Complicated Urinary Tract Infection (cUTI) Including Acute Pyelonephritis
Conditions
Keywords
Ceftazidime, Avibactam, Doripenem, Ciprofloxacin, sulfamethoxazole/trimethoprim, Anti-Infective Agents, Complicated Urinary Tract Infection,Acute Pyelonephritis
Brief summary
The purpose of this study is to evaluate the effects of Ceftazidime Avibactam compared to Doripenem for treating hospitalized patients with complicated urinary tract infections, including acute pyelonephritis
Detailed description
A Phase III, Randomized, Multicenter, Double-Blind, Double Dummy, Parallel Group, Comparative Study to Determine the Efficacy, Safety, and Tolerability of Ceftazidime Avibactam (CAZ-AVI, formerly CAZ104) Versus Doripenem Followed by Appropriate Oral Therapy in the Treatment of Complicated Urinary Tract Infections, Including Acute Pyelonephritis, With a Gram Negative Pathogen in Hospitalized Adults
Interventions
Ceftazidime 2000 mg and 500 mg of avibactam. Patients randomized to receive CAZ-AVI will receive an infusion of CAZ-AVI (2000 mg ceftazidime and 500 mg avibactam) every 8 hours administered by intravenous (IV) infusion in a volume of 100 mL at a constant rate over 120 minutes
DRUGDoripenem
500 mg of Doripenem. Patients randomized to receive Doripenem will receive an infusion of Doripenem 500 mg every 8 hours administered by intravenous (IV) infusion in a volume of 100 mL at a constant rate over 60 minutes
Patients are eligible for oral switch after receiving 5 full days of IV therapy and have met protocol specified criteria for clinical improvement
Patients are eligible for oral switch after receiving 5 full days of IV therapy and have met protocol specified criteria for clinical improvement
Sponsors
Forest Laboratories
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* 18 to 90 years of age inclusive * Female patients can participate if they are surgically sterile or completed menopause or females capable of having children and agree not to attempt pregnancy while receiving IV study therapy and for a period of 7 days after * Has pyuria with \>/= 10 WBCs (white blood cell) and has a positive urine culture within 48 hours of enrollment containing \>/=10 to the fifth CFU (colony forming unit ) /ml of a recognized uropathogen known to be susceptible to IV study therapy (CAZ-AVI and doripenem) * Demonstrates either acute pyelonephritis or complicated lower UTI without pyelonephritis
Exclusion criteria
* Urine pathogen is a Gram-positive pathogen or a uropathogen resistant to CAZ-AVI or doripenem * Patient's urine culture at study entry isolates more than 2 microorganisms regardless of colony count or patient has a confirmed fungal UTI * Patient is receiving hemodialysis or peritoneal dialysis or had a renal transplant * Patient is immunocompromised * Patient is considered unlikely to survive the 6- to 8-week study period or has a rapidly progressive or terminal illness including septic shock which is associated with a high risk of mortality
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient-reported Symptomatic Response at Day 5 (mMITT Analysis Set): Non-inferiority Hypothesis Test | At Day 5 visit. Day 5 visit is based on 24 hour periods from the first dose date and time. | Number of patients with symptomatic resolution (or return to premorbid state) of UTI-specific symptoms except flank pain (frequency/urgency/dysuria/suprapubic pain) with resolution of or improvement in flank pain based on the patient-reported symptom assessment response at the Day 5 visit in the mMITT analysis set. The sponsor will conclude noninferiority if the lower limit of the 95% CI of difference (corresponding to a 97.5% 1-sided lower bound) is greater than -12.5% for both FDA coprimary outcome variables (symptomatic resolution at day 5 or favorable combined response at test of cure (TOC)). |
| Combined Patient-reported Symptomatic and Microbiological Response at TOC (mMITT Analysis Set): Non-inferiority Hypothesis Test | At TOC visit. TOC visit is 21 to 25 days from Randomization. | Number of patients with both a favorable per patient microbiological response and symptomatic resolution (or return to premorbid state) of all UTI-specific symptoms (frequency/urgency/dysuria/suprapubic pain/flank pain) based on the patient-reported symptom assessment response at the TOC visit in the mMITT analysis set. The sponsor will conclude noninferiority if the lower limit of the 95% CI of difference (corresponding to a 97.5% 1-sided lower bound) is greater than -12.5% for both FDA coprimary outcome variables (symptomatic resolution at day 5 or favorable combined response at test of cure (TOC)). |
| Per-patient Microbiological Response at TOC (mMITT Analysis Set): Non-inferiority Hypothesis Test | At TOC visit. TOC visit is 21 to 25 days from Randomization. | Number of patients with a favorable per patient microbiological response at TOC. The primary efficacy outcome variable for ROW is the proportion of patients with a favorable per-patient microbiological response at the TOC visit in the mMITT analysis set. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Per-patient Microbiological Response at TOC (ME at TOC Analysis Set) | At TOC visit. TOC visit is 21 to 25 days from Randomization. | Number of patients with a favorable per patient microbiological response at TOC |
| Per-patient Microbiological Response at LFU (ME at LFU Analysis Set) | At LFU visit. LFU visit is 45 to 52 days from Randomization. | Number of patients with a favorable per patient microbiological response at LFU |
| Per-patient Microbiological Response at EOT (IV) (Extended ME at EOT (IV) Analysis Set) | At EOT (IV) visit. EOT (IV) visit is Within 24 hours after completion of the last infusion of IV study therapy and on/before the first dose for oral study therapy | Number of patients with a favorable per-patient microbiological response at EOT (IV) |
| Per-patient Microbiological Response at TOC (Extended ME at TOC Analysis Set) | At TOC visit. TOC visit is 21 to 25 days from Randomization. | Number of patients with a favorable per patient microbiological response at TOC |
| Per-patient Microbiological Response at LFU (Extended ME at LFU Analysis Set) | At LFU visit. LFU visit is 45 to 52 days from Randomization. | Number of patients with a favorable per patient microbiological response at LFU |
| Investigator Determined Clinical Response at EOT (IV) (mMITT Analysis Set) | At EOT (IV) visit. EOT (IV) visit is Within 24 hours after completion of the last infusion of IV study therapy and on/before the first dose for oral study therapy | Number of patients with a clinical cure at EOT (IV). The investigator should consider the entirety of the patient's clinical course and current status, including an evaluation of signs and symptoms (eg, fever, dysuria, costovertebral angle tenderness) and physical examination in order to classify the patient's clinical response. |
| Investigator Determined Clinical Response at TOC (mMITT Analysis Set) | At TOC visit. TOC visit is 21 to 25 days from Randomization. | Number of patients with a clinical cure at TOC. The investigator should consider the entirety of the patient's clinical course and current status, including an evaluation of signs and symptoms (eg, fever, dysuria, costovertebral angle tenderness) and physical examination in order to classify the patient's clinical response. |
| Investigator Determined Clinical Response at LFU (mMITT Analysis Set) | At LFU visit. LFU visit is 45 to 52 days from Randomization. | Number of patients with a clinical cure at LFU. The investigator should consider the entirety of the patient's clinical course and current status, including an evaluation of signs and symptoms (eg, fever, dysuria, costovertebral angle tenderness) and physical examination in order to classify the patient's clinical response. |
| Investigator Determined Clinical Response at EOT (IV) (ME at EOT (IV) Analysis Set) | At EOT (IV) visit. EOT (IV) visit is Within 24 hours after completion of the last infusion of IV study therapy and on/before the first dose for oral study therapy | Number of patients with a clinical cure at EOT (IV). The investigator should consider the entirety of the patient's clinical course and current status, including an evaluation of signs and symptoms (eg, fever, dysuria, costovertebral angle tenderness) and physical examination in order to classify the patient's clinical response. |
| Investigator Determined Clinical Response at TOC (ME at TOC Analysis Set) | At TOC visit. TOC visit is 21 to 25 days from Randomization. | Number of patients with a clinical cure at TOC. The investigator should consider the entirety of the patient's clinical course and current status, including an evaluation of signs and symptoms (eg, fever, dysuria, costovertebral angle tenderness) and physical examination in order to classify the patient's clinical response. |
| Investigator Determined Clinical Response at LFU (ME at LFU Analysis Set) | At LFU visit. LFU visit is 45 to 52 days from Randomization. | Number of patients with a clinical cure at LFU. The investigator should consider the entirety of the patient's clinical course and current status, including an evaluation of signs and symptoms (eg, fever, dysuria, costovertebral angle tenderness) and physical examination in order to classify the patient's clinical response. |
| Investigator Determined Clinical Response at EOT (IV) (Extended ME at EOT (IV) Analysis Set) | At EOT (IV) visit. EOT (IV) visit is Within 24 hours after completion of the last infusion of IV study therapy and on/before the first dose for oral study therapy | Number of patients with a clinical cure at EOT (IV). The investigator should consider the entirety of the patient's clinical course and current status, including an evaluation of signs and symptoms (eg, fever, dysuria, costovertebral angle tenderness) and physical examination in order to classify the patient's clinical response. |
| Investigator Determined Clinical Response at TOC (Extended ME at TOC Analysis Set) | At TOC visit. TOC visit is 21 to 25 days from Randomization. | Number of patients with a clinical cure at TOC. The investigator should consider the entirety of the patient's clinical course and current status, including an evaluation of signs and symptoms (eg, fever, dysuria, costovertebral angle tenderness) and physical examination in order to classify the patient's clinical response. |
| Investigator Determined Clinical Response at LFU (Extended ME at LFU Analysis Set) | At LFU visit. LFU visit is 45 to 52 days from Randomization. | Number of patients with a clinical cure at LFU. The investigator should consider the entirety of the patient's clinical course and current status, including an evaluation of signs and symptoms (eg, fever, dysuria, costovertebral angle tenderness) and physical examination in order to classify the patient's clinical response. |
| Investigator Determined Clinical Response at EOT (IV) (CE at EOT (IV) Analysis Set) | At EOT (IV) visit. EOT (IV) visit is Within 24 hours after completion of the last infusion of IV study therapy and on/before the first dose for oral study therapy | Number of patients with a clinical cure at EOT (IV). The investigator should consider the entirety of the patient's clinical course and current status, including an evaluation of signs and symptoms (eg, fever, dysuria, costovertebral angle tenderness) and physical examination in order to classify the patient's clinical response. |
| Investigator Determined Clinical Response at TOC (CE at TOC Analysis Set) | At TOC visit. TOC visit is 21 to 25 days from Randomization. | Number of patients with a clinical cure at TOC. The investigator should consider the entirety of the patient's clinical course and current status, including an evaluation of signs and symptoms (eg, fever, dysuria, costovertebral angle tenderness) and physical examination in order to classify the patient's clinical response. |
| Investigator Determined Clinical Response at LFU (CE at LFU Analysis Set) | At LFU visit. LFU visit is 45 to 52 days from Randomization. | Number of patients with a clinical cure at LFU. The investigator should consider the entirety of the patient's clinical course and current status, including an evaluation of signs and symptoms (eg, fever, dysuria, costovertebral angle tenderness) and physical examination in order to classify the patient's clinical response. |
| Investigator Determined Clinical Response at TOC for Patients Infected by Ceftazidime-resistant Gram-negative Pathogen (mMITT Analysis Set) | At TOC visit. TOC visit is 21 to 25 days from Randomization. | Clinical cure at the TOC visit for patients infected with a ceftazidime resistant pathogen in the mMITT analysis set. Includes patients infected by at least one ceftazidime-resistant Gram-negative pathogen. |
| Investigator Determined Clinical Response at TOC for Patients Infected by Ceftazidime-resistant Gram-negative Pathogen (ME at TOC Analysis Set) | At TOC visit. TOC visit is 21 to 25 days from Randomization. | Clinical cure at the TOC visit for patients infected with a ceftazidime resistant pathogen in the ME at TOC analysis set. Includes patients infected by at least one ceftazidime-resistant Gram-negative pathogen. |
| Investigator Determined Clinical Response at TOC for Patients Infected by Ceftazidime-resistant Gram-negative Pathogen (Extended ME at TOC Analysis Set) | At TOC visit. TOC visit is 21 to 25 days from Randomization. | Clinical cure at the TOC visit for patients infected with a ceftazidime resistant pathogen in the Extended ME at TOC analysis set. Includes patients infected by at least one ceftazidime-resistant Gram-negative pathogen. |
| Per-patient Microbiological Response at TOC in Patients Infected by Ceftazidime-resistant Gram-negative Pathogen (mMITT Analysis Set) | At TOC visit. TOC visit is 21 to 25 days from Randomization. | Favorable per-patient microbiological response at the TOC visit for patients infected with a ceftazidime resistant pathogen in the mMITT analysis set. |
| Per-patient Microbiological Response at TOC in Patients Infected by Ceftazidime-resistant Gram-negative Pathogen (ME at TOC Analysis Set) | At TOC visit. TOC visit is 21 to 25 days from Randomization. | Favorable per-patient microbiological response at the TOC visit for patients infected with a ceftazidime resistant pathogen in the ME at TOC analysis set. |
| Per-patient Microbiological Response at TOC in Patients Infected by Ceftazidime-resistant Gram-negative Pathogen (Extended ME at TOC Analysis Set) | At TOC visit. TOC visit is 21 to 25 days from Randomization. | Favorable per-patient microbiological response at the TOC visit for patients infected with a ceftazidime resistant pathogen in the Extended ME at TOC analysis set. |
| Time to First Defervescence While on IV Study Therapy (mMITT Analysis Set) | Time to first defervescence is defined as the time (in days) from the first dose of IV study therapy to first absence of fever, which is temperature ≤ 37.8 C in a 24-hour period. | Time to first defervescence while on IV study therapy in patients in the mMITT analysis set who have fever at study entry. |
| Time to First Defervescence While on IV Study Therapy (ME at TOC Analysis Set) | Time to first defervescence is defined as the time (in days) from the first dose of IV study therapy to first absence of fever, which is temperature ≤ 37.8 C in a 24-hour period. | Time to first defervescence while on IV study therapy in patients in the ME at TOC analysis set who have fever at study entry. |
| Time to First Defervescence While on IV Study Therapy (Extended ME at TOC Analysis Set) | Time to first defervescence is defined as the time (in days) from the first dose of IV study therapy to first absence of fever, which is temperature ≤ 37.8 C in a 24-hour period. | Time to first defervescence while on IV study therapy in patients in the Extended ME at TOC analysis set who have fever at study entry. |
| Time to First Defervescence While on IV Study Therapy (CE at TOC Analysis Set) | Time to first defervescence is defined as the time (in days) from the first dose of IV study therapy to first absence of fever, which is temperature ≤ 37.8 C in a 24-hour period. | Time to first defervescence while on IV study therapy in patients in the CE at TOC analysis set who have fever at study entry. |
| Per-pathogen Microbiological Response at EOT (IV) for Baseline Pathogen (mMITT Analysis Set) | At EOT IV visit. EOT (IV) visit is Within 24 hours after completion of the last infusion of IV study therapy and on/before the first dose for oral study therapy | Number of favorable per-pathogen microbiological responses at the EOT (IV) visit in the mMITT analysis set |
| Per-pathogen Microbiological Response at TOC for Baseline Pathogen (mMITT Analysis Set) | At TOC visit. TOC visit is 21 to 25 days from Randomization | Number of favorable per-pathogen microbiological responses at the TOC visit in the mMITT analysis set |
| Per-pathogen Microbiological Response at LFU for Baseline Pathogen (Extended ME at LFU Analysis Set) | At LFU visit. LFU visit is 45 to 52 days from Randomization. | Number of favorable per-pathogen microbiological responses at the LFU visit in the Extended ME at LFU analysis set |
| Per-pathogen Microbiological Response at LFU for Baseline Pathogen (mMITT Analysis Set) | At LFU visit. LFU visit is 45 to 52 days from Randomization | Number of favorable per-pathogen microbiological responses at the LFU visit in the mMITT analysis set |
| Per-pathogen Microbiological Response at EOT (IV) for Baseline Pathogen (Extended ME at EOT (IV) Analysis Set) | At EOT IV visit. EOT (IV) visit is Within 24 hours after completion of the last infusion of IV study therapy and on/before the first dose for oral study therapy | Number of favorable per-pathogen microbiological responses at the EOT (IV) visit in the Extended ME at EOT (IV) analysis set |
| Per-pathogen Microbiological Response at TOC for Baseline Pathogen (Extended ME at TOC Analysis Set) | At TOC visit. TOC visit is 21 to 25 days from Randomization. | Number of favorable per-pathogen microbiological responses at the TOC visit in the Extended ME at TOC analysis set |
| Per-pathogen Microbiological Response at EOT (IV) for Baseline Pathogen (ME at EOT (IV) Analysis Set) | At EOT (IV) visit. EOT (IV) visit is Within 24 hours after completion of the last infusion of IV study therapy and on/before the first dose for oral study therapy | Number of favorable per-pathogen microbiological responses at the EOT (IV) visit in the ME at EOT (IV) analysis set |
| Per-pathogen Microbiological Response at TOC for Baseline Pathogen (ME at TOC Analysis Set) | At TOC visit. TOC visit is 21 to 25 days from Randomization. | Number of favorable per-pathogen microbiological responses at the TOC visit in the ME at TOC analysis set |
| Per-pathogen Microbiological Response at LFU for Baseline Pathogen (ME at LFU Analysis Set) | At LFU visit. LFU visit is 45 to 52 days from Randomization. | Number of favorable per-pathogen microbiological responses at the LFU visit in the ME at LFU analysis set |
| Per-pathogen Microbiological Response at EOT (IV) for Blood Only (mMITT Analysis Set) | At EOT IV visit. EOT (IV) visit is Within 24 hours after completion of the last infusion of IV study therapy and on/before the first dose for oral study therapy | Number of favorable per-pathogen microbiological responses at the EOT (IV) visit in the mMITT analysis set for blood only |
| Per-pathogen Microbiological Response at TOC for Blood Only (mMITT Analysis Set) | At TOC visit. TOC visit is 21 to 25 days from Randomization | Number of favorable per-pathogen microbiological responses at the TOC visit in the mMITT analysis set for blood only |
| Per-pathogen Microbiological Response at LFU for Blood Only (mMITT Analysis Set) | At LFU visit. LFU visit is 45 to 52 days from Randomization | Number of favorable per-pathogen microbiological responses at the LFU visit in the mMITT analysis set for blood only |
| Per-pathogen Microbiological Response at EOT (IV) for Blood Only (Extended ME at EOT (IV) Analysis Set) | At EOT IV visit. EOT (IV) visit is Within 24 hours after completion of the last infusion of IV study therapy and on/before the first dose for oral study therapy | Number of favorable per-pathogen microbiological responses at the EOT (IV) visit in the Extended ME at EOT (IV) analysis set for blood only |
| Per-pathogen Microbiological Response at TOC for Blood Only (Extended ME at TOC Analysis Set) | At TOC visit. TOC visit is 21 to 25 days from Randomization. | Number of favorable per-pathogen microbiological responses at the TOC visit in the Extended ME at TOC analysis set for blood only |
| Per-pathogen Microbiological Response at LFU for Blood Only (Extended ME at LFU Analysis Set) | At LFU visit. LFU visit is 45 to 52 days from Randomization. | Number of favorable per-pathogen microbiological responses at the LFU visit in the Extended ME at LFU analysis set for blood only |
| Per-pathogen Microbiological Response at EOT (IV) for Blood Only (ME at EOT (IV) Analysis Set) | At EOT (IV) visit. EOT (IV) visit is Within 24 hours after completion of the last infusion of IV study therapy and on/before the first dose for oral study therapy | Number of favorable per-pathogen microbiological responses at the EOT (IV) visit in the ME at EOT (IV) analysis set for blood only |
| Per-pathogen Microbiological Response at TOC for Blood Only (ME at TOC Analysis Set) | At TOC visit. TOC visit is 21 to 25 days from Randomization. | Number of favorable per-pathogen microbiological responses at the TOC visit in the ME at TOC analysis set for blood only |
| Per-pathogen Microbiological Response at LFU for Blood Only (ME at LFU Analysis Set) | At LFU visit. LFU visit is 45 to 52 days from Randomization. | Number of favorable per-pathogen microbiological responses at the LFU visit in the ME at LFU analysis set for blood only |
| Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (mMITT Analysis Set) | At TOC visit. TOC visit is 21 to 25 days from Randomization | Per pathogen microbiological response at TOC by CAZ-AVI MIC for baseline pathogen in the mMITT analysis set |
| Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (Extended ME at TOC Analysis Set) | At TOC visit. TOC visit is 21 to 25 days from Randomization | Per pathogen microbiological response at TOC by CAZ-AVI MIC for baseline pathogen in the Extended ME at TOC analysis set |
| Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (ME at TOC Analysis Set) | At TOC visit. TOC visit is 21 to 25 days from Randomization | Per pathogen microbiological response at TOC by CAZ-AVI MIC for baseline pathogen in the ME at TOC analysis set |
| Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (mMITT Analysis Set) | At TOC visit. TOC visit is 21 to 25 days from Randomization | Per pathogen microbiological response at TOC by Doripenem MIC for baseline pathogen in the mMITT analysis set |
| Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (Extended ME at TOC Analysis Set) | At TOC visit. TOC visit is 21 to 25 days from Randomization | Per pathogen microbiological response at TOC by Doripenem MIC for baseline pathogen in the Extended ME at TOC analysis set |
| Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (ME at TOC Analysis Set) | At TOC visit. TOC visit is 21 to 25 days from Randomization | Per pathogen microbiological response at TOC by Doripenem MIC for baseline pathogen in the ME at TOC analysis set |
| Plasma Concentrations for Ceftazidime Within 15 Minutes Before/After Dose (PK Analysis Set) | within 15 minutes before/after dose | Blood samples were taken on Day 3 for ceftazidime (CAZ) and avibactam (AVI) plasma concentration. |
| Per-patient Microbiological Response at EOT (IV) (mMITT Analysis Set) | At EOT (IV) visit. EOT (IV) visit is Within 24 hours after completion of the last infusion of IV study therapy and on/before the first dose for oral study therapy | Number of patients with a favorable per-patient microbiological response at EOT (IV) |
| Plasma Concentrations for Ceftazidime Between 300 to 360 Minutes After Dose(PK Analysis Set) | Between 300 to 360 minutes after dose | Blood samples were taken on Day 3 for ceftazidime (CAZ) and avibactam (AVI) plasma concentration. |
| Plasma Concentrations for Avibactam Within 15 Minutes Before/After Dose (PK Analysis Set) | within 15 minutes before/after dose | Blood samples were taken on Day 3 for ceftazidime (CAZ) and avibactam (AVI) plasma concentration. |
| Plasma Concentrations for Avibactam Between 30 to 90 Minutes After Dose(PK Analysis Set) | Between 30 to 90 minutes after dose | Blood samples were taken on Day 3 for ceftazidime (CAZ) and avibactam (AVI) plasma concentration. |
| Plasma Concentrations for Avibactam Between 300 to 360 Minutes After Dose(PK Analysis Set) | Between 300 to 360 minutes after dose | Blood samples were taken on Day 3 for ceftazidime (CAZ) and avibactam (AVI) plasma concentration. |
| Plasma Concentrations for Ceftazidime Between 30 to 90 Minutes After Dose(PK Analysis Set) | Between 30 to 90 minutes after dose | Blood samples were taken on Day 3 for ceftazidime (CAZ) and avibactam (AVI) plasma concentration. |
| Per-patient Microbiological Response at LFU (mMITT Analysis Set) | At LFU visit. LFU visit is 45 to 52 days from Randomization. | Number of patients with a favorable per patient microbiological response at LFU |
| Per-patient Microbiological Response at EOT (IV) (ME at EOT (IV) Analysis Set) | At EOT (IV) visit. EOT (IV) visit is Within 24 hours after completion of the last infusion of IV study therapy and on/before the first dose for oral study therapy | Number of patients with a favorable per-patient microbiological response at EOT (IV) |
Countries
Argentina, Bulgaria, Croatia, Czechia, Germany, Israel, Italy, Mexico, Peru, Poland, Romania, Russia, South Korea, Spain, Taiwan, Ukraine, United States
Participant flow
Pre-assignment details
The results presented in these forms represent the combined data base of the two identical protocols D4280C00002 and D4280C00004. The protocol D4280C00002 has a total of 522 randomized patients and the protocol D4280C00004 has a total of 511 randomized patients which adds up to a combined total of 1033 patients.
Participants by arm
| Arm | Count |
|---|---|
| CAZ-AVI Ceftazidime-avibactam treatment group | 511 |
| Doripenem Doripenem treatment group | 509 |
| Total | 1,020 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 20 | 20 |
| Overall Study | Other Eligibility criteria | 11 | 9 |
| Overall Study | Withdrawal by Subject | 12 | 12 |
Baseline characteristics
| Characteristic | CAZ-AVI | Doripenem | Total |
|---|---|---|---|
| Age, Continuous | 51.6 Years STANDARD_DEVIATION 19.76 | 52.3 Years STANDARD_DEVIATION 18.83 | 52.0 Years STANDARD_DEVIATION 19.29 |
| Age, Customized 18-45 | 192 Participants | 172 Participants | 364 Participants |
| Age, Customized 46-64 | 162 Participants | 177 Participants | 339 Participants |
| Age, Customized 65-74 | 79 Participants | 98 Participants | 177 Participants |
| Age, Customized 75-90 | 78 Participants | 62 Participants | 140 Participants |
| Race/Ethnicity, Customized American Indian Or Alaska Native | 1 Participants | 3 Participants | 4 Participants |
| Race/Ethnicity, Customized Asian | 48 Participants | 37 Participants | 85 Participants |
| Race/Ethnicity, Customized Black Or African American | 1 Participants | 8 Participants | 9 Participants |
| Race/Ethnicity, Customized Other | 40 Participants | 35 Participants | 75 Participants |
| Race/Ethnicity, Customized White | 421 Participants | 426 Participants | 847 Participants |
| Sex: Female, Male Female | 349 Participants | 357 Participants | 706 Participants |
| Sex: Female, Male Male | 162 Participants | 152 Participants | 314 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 67 / 511 | 57 / 509 |
| serious Total, serious adverse events | 21 / 511 | 12 / 509 |
Outcome results
Primary
Combined Patient-reported Symptomatic and Microbiological Response at TOC (mMITT Analysis Set): Non-inferiority Hypothesis Test
Number of patients with both a favorable per patient microbiological response and symptomatic resolution (or return to premorbid state) of all UTI-specific symptoms (frequency/urgency/dysuria/suprapubic pain/flank pain) based on the patient-reported symptom assessment response at the TOC visit in the mMITT analysis set. The sponsor will conclude noninferiority if the lower limit of the 95% CI of difference (corresponding to a 97.5% 1-sided lower bound) is greater than -12.5% for both FDA coprimary outcome variables (symptomatic resolution at day 5 or favorable combined response at test of cure (TOC)).
Time frame: At TOC visit. TOC visit is 21 to 25 days from Randomization.
Population: Microbiological modified intent to treat analysis set (mMITT)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CAZ-AVI | Combined Patient-reported Symptomatic and Microbiological Response at TOC (mMITT Analysis Set): Non-inferiority Hypothesis Test | Favorable | 280 Participants |
| CAZ-AVI | Combined Patient-reported Symptomatic and Microbiological Response at TOC (mMITT Analysis Set): Non-inferiority Hypothesis Test | Unfavorable | 81 Participants |
| CAZ-AVI | Combined Patient-reported Symptomatic and Microbiological Response at TOC (mMITT Analysis Set): Non-inferiority Hypothesis Test | Indeterminate | 32 Participants |
| Doripenem | Combined Patient-reported Symptomatic and Microbiological Response at TOC (mMITT Analysis Set): Non-inferiority Hypothesis Test | Favorable | 269 Participants |
| Doripenem | Combined Patient-reported Symptomatic and Microbiological Response at TOC (mMITT Analysis Set): Non-inferiority Hypothesis Test | Unfavorable | 109 Participants |
| Doripenem | Combined Patient-reported Symptomatic and Microbiological Response at TOC (mMITT Analysis Set): Non-inferiority Hypothesis Test | Indeterminate | 39 Participants |
Comparison: H0: Difference (CAZ-AVI treatment group minus Doripenem treatment group) of favorable combined response rates ≤ non-inferiority margin95% CI: [0.3, 13.12]Unstratified Miettinen & Nurminen method
Primary
Patient-reported Symptomatic Response at Day 5 (mMITT Analysis Set): Non-inferiority Hypothesis Test
Number of patients with symptomatic resolution (or return to premorbid state) of UTI-specific symptoms except flank pain (frequency/urgency/dysuria/suprapubic pain) with resolution of or improvement in flank pain based on the patient-reported symptom assessment response at the Day 5 visit in the mMITT analysis set. The sponsor will conclude noninferiority if the lower limit of the 95% CI of difference (corresponding to a 97.5% 1-sided lower bound) is greater than -12.5% for both FDA coprimary outcome variables (symptomatic resolution at day 5 or favorable combined response at test of cure (TOC)).
Time frame: At Day 5 visit. Day 5 visit is based on 24 hour periods from the first dose date and time.
Population: Microbiological modified intent to treat analysis set (mMITT)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CAZ-AVI | Patient-reported Symptomatic Response at Day 5 (mMITT Analysis Set): Non-inferiority Hypothesis Test | Symptomatic resolution | 276 Participants |
| CAZ-AVI | Patient-reported Symptomatic Response at Day 5 (mMITT Analysis Set): Non-inferiority Hypothesis Test | Symptom persistence | 103 Participants |
| CAZ-AVI | Patient-reported Symptomatic Response at Day 5 (mMITT Analysis Set): Non-inferiority Hypothesis Test | Indeterminate | 14 Participants |
| Doripenem | Patient-reported Symptomatic Response at Day 5 (mMITT Analysis Set): Non-inferiority Hypothesis Test | Symptomatic resolution | 276 Participants |
| Doripenem | Patient-reported Symptomatic Response at Day 5 (mMITT Analysis Set): Non-inferiority Hypothesis Test | Symptom persistence | 124 Participants |
| Doripenem | Patient-reported Symptomatic Response at Day 5 (mMITT Analysis Set): Non-inferiority Hypothesis Test | Indeterminate | 17 Participants |
Comparison: H0: Difference (CAZ-AVI treatment group minus Doripenem treatment group) of symptomatic resolution rates ≤ non-inferiority margin95% CI: [-2.39, 10.42]Unstratified Miettinen & Nurminen method
Primary
Per-patient Microbiological Response at TOC (mMITT Analysis Set): Non-inferiority Hypothesis Test
Number of patients with a favorable per patient microbiological response at TOC. The primary efficacy outcome variable for ROW is the proportion of patients with a favorable per-patient microbiological response at the TOC visit in the mMITT analysis set.
Time frame: At TOC visit. TOC visit is 21 to 25 days from Randomization.
Population: Microbiological modified intent to treat analysis set (mMITT)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CAZ-AVI | Per-patient Microbiological Response at TOC (mMITT Analysis Set): Non-inferiority Hypothesis Test | Favorable | 304 Participants |
| CAZ-AVI | Per-patient Microbiological Response at TOC (mMITT Analysis Set): Non-inferiority Hypothesis Test | Unfavorable | 58 Participants |
| CAZ-AVI | Per-patient Microbiological Response at TOC (mMITT Analysis Set): Non-inferiority Hypothesis Test | Indeterminate | 31 Participants |
| Doripenem | Per-patient Microbiological Response at TOC (mMITT Analysis Set): Non-inferiority Hypothesis Test | Favorable | 296 Participants |
| Doripenem | Per-patient Microbiological Response at TOC (mMITT Analysis Set): Non-inferiority Hypothesis Test | Unfavorable | 83 Participants |
| Doripenem | Per-patient Microbiological Response at TOC (mMITT Analysis Set): Non-inferiority Hypothesis Test | Indeterminate | 38 Participants |
Comparison: H0: Difference (CAZ-AVI treatment group minus Doripenem treatment group) of favorable response rates ≤ non-inferiority margin95% CI: [0.33, 12.36]Unstratified Miettinen & Nurminen method
Secondary
Investigator Determined Clinical Response at EOT (IV) (CE at EOT (IV) Analysis Set)
Number of patients with a clinical cure at EOT (IV). The investigator should consider the entirety of the patient's clinical course and current status, including an evaluation of signs and symptoms (eg, fever, dysuria, costovertebral angle tenderness) and physical examination in order to classify the patient's clinical response.
Time frame: At EOT (IV) visit. EOT (IV) visit is Within 24 hours after completion of the last infusion of IV study therapy and on/before the first dose for oral study therapy
Population: Clinically evaluable analysis set at EOT (IV) (CE at EOT (IV))
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CAZ-AVI | Investigator Determined Clinical Response at EOT (IV) (CE at EOT (IV) Analysis Set) | Clinical cure | 346 Participants |
| CAZ-AVI | Investigator Determined Clinical Response at EOT (IV) (CE at EOT (IV) Analysis Set) | Clinical failure | 4 Participants |
| Doripenem | Investigator Determined Clinical Response at EOT (IV) (CE at EOT (IV) Analysis Set) | Clinical cure | 387 Participants |
| Doripenem | Investigator Determined Clinical Response at EOT (IV) (CE at EOT (IV) Analysis Set) | Clinical failure | 4 Participants |
Comparison: Confidence interval of the difference (CAZ-AVI treatment group minus Doripenem treatment group) of clinical cure rates95% CI: [-1.99, 1.61]Unstratified Miettinen & Nurminen method
Secondary
Investigator Determined Clinical Response at EOT (IV) (Extended ME at EOT (IV) Analysis Set)
Number of patients with a clinical cure at EOT (IV). The investigator should consider the entirety of the patient's clinical course and current status, including an evaluation of signs and symptoms (eg, fever, dysuria, costovertebral angle tenderness) and physical examination in order to classify the patient's clinical response.
Time frame: At EOT (IV) visit. EOT (IV) visit is Within 24 hours after completion of the last infusion of IV study therapy and on/before the first dose for oral study therapy
Population: Extended microbiological evaluable analysis set at EOT (IV) (Extended ME at EOT (IV))
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CAZ-AVI | Investigator Determined Clinical Response at EOT (IV) (Extended ME at EOT (IV) Analysis Set) | Clinical cure | 327 Participants |
| CAZ-AVI | Investigator Determined Clinical Response at EOT (IV) (Extended ME at EOT (IV) Analysis Set) | Clinical failure | 4 Participants |
| CAZ-AVI | Investigator Determined Clinical Response at EOT (IV) (Extended ME at EOT (IV) Analysis Set) | Indeterminate | 5 Participants |
| Doripenem | Investigator Determined Clinical Response at EOT (IV) (Extended ME at EOT (IV) Analysis Set) | Clinical cure | 368 Participants |
| Doripenem | Investigator Determined Clinical Response at EOT (IV) (Extended ME at EOT (IV) Analysis Set) | Clinical failure | 2 Participants |
| Doripenem | Investigator Determined Clinical Response at EOT (IV) (Extended ME at EOT (IV) Analysis Set) | Indeterminate | 1 Participants |
Comparison: Confidence interval of the difference (CAZ-AVI treatment group minus Doripenem treatment group) of clinical cure rates95% CI: [-4.3, 0.04]Unstratified Miettinen & Nurminen method
Secondary
Investigator Determined Clinical Response at EOT (IV) (ME at EOT (IV) Analysis Set)
Number of patients with a clinical cure at EOT (IV). The investigator should consider the entirety of the patient's clinical course and current status, including an evaluation of signs and symptoms (eg, fever, dysuria, costovertebral angle tenderness) and physical examination in order to classify the patient's clinical response.
Time frame: At EOT (IV) visit. EOT (IV) visit is Within 24 hours after completion of the last infusion of IV study therapy and on/before the first dose for oral study therapy
Population: Microbiological evaluable analysis set at EOT (IV) (ME at EOT (IV))
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CAZ-AVI | Investigator Determined Clinical Response at EOT (IV) (ME at EOT (IV) Analysis Set) | Clinical cure | 318 Participants |
| CAZ-AVI | Investigator Determined Clinical Response at EOT (IV) (ME at EOT (IV) Analysis Set) | Clinical failure | 4 Participants |
| CAZ-AVI | Investigator Determined Clinical Response at EOT (IV) (ME at EOT (IV) Analysis Set) | Indeterminate | 3 Participants |
| Doripenem | Investigator Determined Clinical Response at EOT (IV) (ME at EOT (IV) Analysis Set) | Clinical cure | 358 Participants |
| Doripenem | Investigator Determined Clinical Response at EOT (IV) (ME at EOT (IV) Analysis Set) | Clinical failure | 2 Participants |
| Doripenem | Investigator Determined Clinical Response at EOT (IV) (ME at EOT (IV) Analysis Set) | Indeterminate | 1 Participants |
Comparison: Confidence interval of the difference (CAZ-AVI treatment group minus Doripenem treatment group) of clinical cure rates95% CI: [-3.64, 0.55]Unstratified Miettinen & Nurminen method
Secondary
Investigator Determined Clinical Response at EOT (IV) (mMITT Analysis Set)
Number of patients with a clinical cure at EOT (IV). The investigator should consider the entirety of the patient's clinical course and current status, including an evaluation of signs and symptoms (eg, fever, dysuria, costovertebral angle tenderness) and physical examination in order to classify the patient's clinical response.
Time frame: At EOT (IV) visit. EOT (IV) visit is Within 24 hours after completion of the last infusion of IV study therapy and on/before the first dose for oral study therapy
Population: Microbiological modified intent to treat analysis set (mMITT)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CAZ-AVI | Investigator Determined Clinical Response at EOT (IV) (mMITT Analysis Set) | Clinical cure | 378 Participants |
| CAZ-AVI | Investigator Determined Clinical Response at EOT (IV) (mMITT Analysis Set) | Clinical failure | 5 Participants |
| CAZ-AVI | Investigator Determined Clinical Response at EOT (IV) (mMITT Analysis Set) | Indeterminate | 10 Participants |
| Doripenem | Investigator Determined Clinical Response at EOT (IV) (mMITT Analysis Set) | Clinical cure | 407 Participants |
| Doripenem | Investigator Determined Clinical Response at EOT (IV) (mMITT Analysis Set) | Clinical failure | 5 Participants |
| Doripenem | Investigator Determined Clinical Response at EOT (IV) (mMITT Analysis Set) | Indeterminate | 5 Participants |
Comparison: Confidence interval of the difference (CAZ-AVI treatment group minus Doripenem treatment group) of clinical cure rates95% CI: [-4.07, 1.02]Unstratified Miettinen & Nurminen method
Secondary
Investigator Determined Clinical Response at LFU (CE at LFU Analysis Set)
Number of patients with a clinical cure at LFU. The investigator should consider the entirety of the patient's clinical course and current status, including an evaluation of signs and symptoms (eg, fever, dysuria, costovertebral angle tenderness) and physical examination in order to classify the patient's clinical response.
Time frame: At LFU visit. LFU visit is 45 to 52 days from Randomization.
Population: Clinically evaluable analysis set at LFU (CE at LFU)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CAZ-AVI | Investigator Determined Clinical Response at LFU (CE at LFU Analysis Set) | Clinical cure | 235 Participants |
| CAZ-AVI | Investigator Determined Clinical Response at LFU (CE at LFU Analysis Set) | Clinical failure | 19 Participants |
| Doripenem | Investigator Determined Clinical Response at LFU (CE at LFU Analysis Set) | Clinical cure | 254 Participants |
| Doripenem | Investigator Determined Clinical Response at LFU (CE at LFU Analysis Set) | Clinical failure | 33 Participants |
Comparison: Confidence interval of the difference (CAZ-AVI treatment group minus Doripenem treatment group) of clinical cure rates95% CI: [-1, 9.05]Unstratified Miettinen & Nurminen method
Secondary
Investigator Determined Clinical Response at LFU (Extended ME at LFU Analysis Set)
Number of patients with a clinical cure at LFU. The investigator should consider the entirety of the patient's clinical course and current status, including an evaluation of signs and symptoms (eg, fever, dysuria, costovertebral angle tenderness) and physical examination in order to classify the patient's clinical response.
Time frame: At LFU visit. LFU visit is 45 to 52 days from Randomization.
Population: Extended microbiological evaluable analysis set at LFU (Extended ME at LFU)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CAZ-AVI | Investigator Determined Clinical Response at LFU (Extended ME at LFU Analysis Set) | Clinical cure | 232 Participants |
| CAZ-AVI | Investigator Determined Clinical Response at LFU (Extended ME at LFU Analysis Set) | Clinical failure | 15 Participants |
| CAZ-AVI | Investigator Determined Clinical Response at LFU (Extended ME at LFU Analysis Set) | Indeterminate | 4 Participants |
| Doripenem | Investigator Determined Clinical Response at LFU (Extended ME at LFU Analysis Set) | Clinical cure | 246 Participants |
| Doripenem | Investigator Determined Clinical Response at LFU (Extended ME at LFU Analysis Set) | Clinical failure | 24 Participants |
| Doripenem | Investigator Determined Clinical Response at LFU (Extended ME at LFU Analysis Set) | Indeterminate | 2 Participants |
Comparison: Confidence interval of the difference (CAZ-AVI treatment group minus Doripenem treatment group) of clinical cure rates95% CI: [-2.94, 6.91]Unstratified Miettinen & Nurminen method
Secondary
Investigator Determined Clinical Response at LFU (ME at LFU Analysis Set)
Number of patients with a clinical cure at LFU. The investigator should consider the entirety of the patient's clinical course and current status, including an evaluation of signs and symptoms (eg, fever, dysuria, costovertebral angle tenderness) and physical examination in order to classify the patient's clinical response.
Time frame: At LFU visit. LFU visit is 45 to 52 days from Randomization.
Population: Microbiological evaluable analysis set at LFU (ME at LFU)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CAZ-AVI | Investigator Determined Clinical Response at LFU (ME at LFU Analysis Set) | Clinical cure | 226 Participants |
| CAZ-AVI | Investigator Determined Clinical Response at LFU (ME at LFU Analysis Set) | Clinical failure | 15 Participants |
| CAZ-AVI | Investigator Determined Clinical Response at LFU (ME at LFU Analysis Set) | Indeterminate | 4 Participants |
| Doripenem | Investigator Determined Clinical Response at LFU (ME at LFU Analysis Set) | Clinical cure | 236 Participants |
| Doripenem | Investigator Determined Clinical Response at LFU (ME at LFU Analysis Set) | Clinical failure | 24 Participants |
| Doripenem | Investigator Determined Clinical Response at LFU (ME at LFU Analysis Set) | Indeterminate | 2 Participants |
Comparison: Confidence interval of the difference (CAZ-AVI treatment group minus Doripenem treatment group) of clinical cure rates95% CI: [-2.9, 7.24]Unstratified Miettinen & Nurminen method
Secondary
Investigator Determined Clinical Response at LFU (mMITT Analysis Set)
Number of patients with a clinical cure at LFU. The investigator should consider the entirety of the patient's clinical course and current status, including an evaluation of signs and symptoms (eg, fever, dysuria, costovertebral angle tenderness) and physical examination in order to classify the patient's clinical response.
Time frame: At LFU visit. LFU visit is 45 to 52 days from Randomization.
Population: Microbiological modified intent to treat analysis set (mMITT)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CAZ-AVI | Investigator Determined Clinical Response at LFU (mMITT Analysis Set) | Clinical cure | 335 Participants |
| CAZ-AVI | Investigator Determined Clinical Response at LFU (mMITT Analysis Set) | Clinical failure | 23 Participants |
| CAZ-AVI | Investigator Determined Clinical Response at LFU (mMITT Analysis Set) | Indeterminate | 35 Participants |
| Doripenem | Investigator Determined Clinical Response at LFU (mMITT Analysis Set) | Clinical cure | 350 Participants |
| Doripenem | Investigator Determined Clinical Response at LFU (mMITT Analysis Set) | Clinical failure | 39 Participants |
| Doripenem | Investigator Determined Clinical Response at LFU (mMITT Analysis Set) | Indeterminate | 28 Participants |
Comparison: Confidence interval of the difference (CAZ-AVI treatment group minus Doripenem treatment group) of clinical cure rates95% CI: [-3.71, 6.3]Unstratified Miettinen & Nurminen method
Secondary
Investigator Determined Clinical Response at TOC (CE at TOC Analysis Set)
Number of patients with a clinical cure at TOC. The investigator should consider the entirety of the patient's clinical course and current status, including an evaluation of signs and symptoms (eg, fever, dysuria, costovertebral angle tenderness) and physical examination in order to classify the patient's clinical response.
Time frame: At TOC visit. TOC visit is 21 to 25 days from Randomization.
Population: Clinically evaluable analysis set at TOC (CE at TOC)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CAZ-AVI | Investigator Determined Clinical Response at TOC (CE at TOC Analysis Set) | Clinical cure | 289 Participants |
| CAZ-AVI | Investigator Determined Clinical Response at TOC (CE at TOC Analysis Set) | Clinical failure | 8 Participants |
| Doripenem | Investigator Determined Clinical Response at TOC (CE at TOC Analysis Set) | Clinical cure | 309 Participants |
| Doripenem | Investigator Determined Clinical Response at TOC (CE at TOC Analysis Set) | Clinical failure | 21 Participants |
Comparison: Confidence interval of the difference (CAZ-AVI treatment group minus Doripenem treatment group) of clinical cure rates95% CI: [0.41, 7.16]Unstratified Miettinen & Nurminen method
Secondary
Investigator Determined Clinical Response at TOC (Extended ME at TOC Analysis Set)
Number of patients with a clinical cure at TOC. The investigator should consider the entirety of the patient's clinical course and current status, including an evaluation of signs and symptoms (eg, fever, dysuria, costovertebral angle tenderness) and physical examination in order to classify the patient's clinical response.
Time frame: At TOC visit. TOC visit is 21 to 25 days from Randomization.
Population: Extended microbiological evaluable analysis set at TOC (Extended ME at TOC)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CAZ-AVI | Investigator Determined Clinical Response at TOC (Extended ME at TOC Analysis Set) | Clinical cure | 283 Participants |
| CAZ-AVI | Investigator Determined Clinical Response at TOC (Extended ME at TOC Analysis Set) | Clinical failure | 4 Participants |
| CAZ-AVI | Investigator Determined Clinical Response at TOC (Extended ME at TOC Analysis Set) | Indeterminate | 5 Participants |
| Doripenem | Investigator Determined Clinical Response at TOC (Extended ME at TOC Analysis Set) | Clinical cure | 298 Participants |
| Doripenem | Investigator Determined Clinical Response at TOC (Extended ME at TOC Analysis Set) | Clinical failure | 13 Participants |
| Doripenem | Investigator Determined Clinical Response at TOC (Extended ME at TOC Analysis Set) | Indeterminate | 0 Participants |
Comparison: Confidence interval of the difference (CAZ-AVI treatment group minus Doripenem treatment group) of clinical cure rates95% CI: [-2.07, 4.32]Unstratified Miettinen & Nurminen method
Secondary
Investigator Determined Clinical Response at TOC for Patients Infected by Ceftazidime-resistant Gram-negative Pathogen (Extended ME at TOC Analysis Set)
Clinical cure at the TOC visit for patients infected with a ceftazidime resistant pathogen in the Extended ME at TOC analysis set. Includes patients infected by at least one ceftazidime-resistant Gram-negative pathogen.
Time frame: At TOC visit. TOC visit is 21 to 25 days from Randomization.
Population: Extended microbiological evaluable analysis set at TOC(Extended ME at TOC)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CAZ-AVI | Investigator Determined Clinical Response at TOC for Patients Infected by Ceftazidime-resistant Gram-negative Pathogen (Extended ME at TOC Analysis Set) | All patients - Clinical cure (n=51, 63) | 50 Participants |
| CAZ-AVI | Investigator Determined Clinical Response at TOC for Patients Infected by Ceftazidime-resistant Gram-negative Pathogen (Extended ME at TOC Analysis Set) | Escherichia coli patients - Clin cure (n=23, 27) | 22 Participants |
| CAZ-AVI | Investigator Determined Clinical Response at TOC for Patients Infected by Ceftazidime-resistant Gram-negative Pathogen (Extended ME at TOC Analysis Set) | Klebsiella pneumoniae patients-Clin cure(n=15, 23) | 15 Participants |
| CAZ-AVI | Investigator Determined Clinical Response at TOC for Patients Infected by Ceftazidime-resistant Gram-negative Pathogen (Extended ME at TOC Analysis Set) | Pseudomonas aeruginosa patients-Clin cure(n=3,6) | 3 Participants |
| CAZ-AVI | Investigator Determined Clinical Response at TOC for Patients Infected by Ceftazidime-resistant Gram-negative Pathogen (Extended ME at TOC Analysis Set) | Enterobacter cloacae patients-Clin cure(n=5,5) | 5 Participants |
| CAZ-AVI | Investigator Determined Clinical Response at TOC for Patients Infected by Ceftazidime-resistant Gram-negative Pathogen (Extended ME at TOC Analysis Set) | Proteus mirabilis patients - Clin cure (n=0, 2) | 0 Participants |
| Doripenem | Investigator Determined Clinical Response at TOC for Patients Infected by Ceftazidime-resistant Gram-negative Pathogen (Extended ME at TOC Analysis Set) | Enterobacter cloacae patients-Clin cure(n=5,5) | 5 Participants |
| Doripenem | Investigator Determined Clinical Response at TOC for Patients Infected by Ceftazidime-resistant Gram-negative Pathogen (Extended ME at TOC Analysis Set) | All patients - Clinical cure (n=51, 63) | 61 Participants |
| Doripenem | Investigator Determined Clinical Response at TOC for Patients Infected by Ceftazidime-resistant Gram-negative Pathogen (Extended ME at TOC Analysis Set) | Pseudomonas aeruginosa patients-Clin cure(n=3,6) | 6 Participants |
| Doripenem | Investigator Determined Clinical Response at TOC for Patients Infected by Ceftazidime-resistant Gram-negative Pathogen (Extended ME at TOC Analysis Set) | Escherichia coli patients - Clin cure (n=23, 27) | 25 Participants |
| Doripenem | Investigator Determined Clinical Response at TOC for Patients Infected by Ceftazidime-resistant Gram-negative Pathogen (Extended ME at TOC Analysis Set) | Proteus mirabilis patients - Clin cure (n=0, 2) | 2 Participants |
| Doripenem | Investigator Determined Clinical Response at TOC for Patients Infected by Ceftazidime-resistant Gram-negative Pathogen (Extended ME at TOC Analysis Set) | Klebsiella pneumoniae patients-Clin cure(n=15, 23) | 23 Participants |
Comparison: Confidence interval of the difference (CAZ-AVI treatment group minus Doripenem treatment group) of clinical cure rates in All patients with a ceftazidime-resistant Gram-negative pathogen95% CI: [-7.5, 9.2]Unstratified Miettinen & Nurminen method
Secondary
Investigator Determined Clinical Response at TOC for Patients Infected by Ceftazidime-resistant Gram-negative Pathogen (ME at TOC Analysis Set)
Clinical cure at the TOC visit for patients infected with a ceftazidime resistant pathogen in the ME at TOC analysis set. Includes patients infected by at least one ceftazidime-resistant Gram-negative pathogen.
Time frame: At TOC visit. TOC visit is 21 to 25 days from Randomization.
Population: Microbiological evaluable analysis set at TOC(ME at TOC)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CAZ-AVI | Investigator Determined Clinical Response at TOC for Patients Infected by Ceftazidime-resistant Gram-negative Pathogen (ME at TOC Analysis Set) | All patients - Clinical cure (n=48, 57) | 47 Participants |
| CAZ-AVI | Investigator Determined Clinical Response at TOC for Patients Infected by Ceftazidime-resistant Gram-negative Pathogen (ME at TOC Analysis Set) | Escherichia coli patients-Clin cure (n=23,27) | 22 Participants |
| CAZ-AVI | Investigator Determined Clinical Response at TOC for Patients Infected by Ceftazidime-resistant Gram-negative Pathogen (ME at TOC Analysis Set) | Klebsiella pneumoniae patients-Clin cure(n=14, 22) | 14 Participants |
| CAZ-AVI | Investigator Determined Clinical Response at TOC for Patients Infected by Ceftazidime-resistant Gram-negative Pathogen (ME at TOC Analysis Set) | Pseudomonas aeruginosa patients-Clin cure(n=1, 2) | 1 Participants |
| CAZ-AVI | Investigator Determined Clinical Response at TOC for Patients Infected by Ceftazidime-resistant Gram-negative Pathogen (ME at TOC Analysis Set) | Enterobacter cloacae patients-Clin cure(n=5,5) | 5 Participants |
| CAZ-AVI | Investigator Determined Clinical Response at TOC for Patients Infected by Ceftazidime-resistant Gram-negative Pathogen (ME at TOC Analysis Set) | Proteus mirabilis patients - Clin cure (n=0, 2) | 0 Participants |
| Doripenem | Investigator Determined Clinical Response at TOC for Patients Infected by Ceftazidime-resistant Gram-negative Pathogen (ME at TOC Analysis Set) | Enterobacter cloacae patients-Clin cure(n=5,5) | 5 Participants |
| Doripenem | Investigator Determined Clinical Response at TOC for Patients Infected by Ceftazidime-resistant Gram-negative Pathogen (ME at TOC Analysis Set) | All patients - Clinical cure (n=48, 57) | 55 Participants |
| Doripenem | Investigator Determined Clinical Response at TOC for Patients Infected by Ceftazidime-resistant Gram-negative Pathogen (ME at TOC Analysis Set) | Pseudomonas aeruginosa patients-Clin cure(n=1, 2) | 2 Participants |
| Doripenem | Investigator Determined Clinical Response at TOC for Patients Infected by Ceftazidime-resistant Gram-negative Pathogen (ME at TOC Analysis Set) | Escherichia coli patients-Clin cure (n=23,27) | 25 Participants |
| Doripenem | Investigator Determined Clinical Response at TOC for Patients Infected by Ceftazidime-resistant Gram-negative Pathogen (ME at TOC Analysis Set) | Proteus mirabilis patients - Clin cure (n=0, 2) | 2 Participants |
| Doripenem | Investigator Determined Clinical Response at TOC for Patients Infected by Ceftazidime-resistant Gram-negative Pathogen (ME at TOC Analysis Set) | Klebsiella pneumoniae patients-Clin cure(n=14, 22) | 22 Participants |
Comparison: Confidence interval of the difference (CAZ-AVI treatment group minus Doripenem treatment group) of clinical cure rates in All patients with a ceftazidime-resistant Gram-negative pathogen95% CI: [-7.8, 10.2]Unstratified Miettinen & Nurminen method
Secondary
Investigator Determined Clinical Response at TOC for Patients Infected by Ceftazidime-resistant Gram-negative Pathogen (mMITT Analysis Set)
Clinical cure at the TOC visit for patients infected with a ceftazidime resistant pathogen in the mMITT analysis set. Includes patients infected by at least one ceftazidime-resistant Gram-negative pathogen.
Time frame: At TOC visit. TOC visit is 21 to 25 days from Randomization.
Population: Microbiological modified intent to treat analysis set (mMITT)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CAZ-AVI | Investigator Determined Clinical Response at TOC for Patients Infected by Ceftazidime-resistant Gram-negative Pathogen (mMITT Analysis Set) | All patients - Clinical cure (n=75, 84) | 67 Participants |
| CAZ-AVI | Investigator Determined Clinical Response at TOC for Patients Infected by Ceftazidime-resistant Gram-negative Pathogen (mMITT Analysis Set) | Escherichia coli patients - Clin cure (n=36, 37) | 33 Participants |
| CAZ-AVI | Investigator Determined Clinical Response at TOC for Patients Infected by Ceftazidime-resistant Gram-negative Pathogen (mMITT Analysis Set) | Klebsiella pneumoniae patients-Clin cure(n=18,30) | 17 Participants |
| CAZ-AVI | Investigator Determined Clinical Response at TOC for Patients Infected by Ceftazidime-resistant Gram-negative Pathogen (mMITT Analysis Set) | Pseudomonas aeruginosa patients- Clin cure(n=7,6) | 5 Participants |
| CAZ-AVI | Investigator Determined Clinical Response at TOC for Patients Infected by Ceftazidime-resistant Gram-negative Pathogen (mMITT Analysis Set) | Enterobacter cloacae patients-Clin cure(n=7,6) | 5 Participants |
| CAZ-AVI | Investigator Determined Clinical Response at TOC for Patients Infected by Ceftazidime-resistant Gram-negative Pathogen (mMITT Analysis Set) | Proteus mirabilis patients - Clin cure (n=2, 5) | 2 Participants |
| Doripenem | Investigator Determined Clinical Response at TOC for Patients Infected by Ceftazidime-resistant Gram-negative Pathogen (mMITT Analysis Set) | Enterobacter cloacae patients-Clin cure(n=7,6) | 5 Participants |
| Doripenem | Investigator Determined Clinical Response at TOC for Patients Infected by Ceftazidime-resistant Gram-negative Pathogen (mMITT Analysis Set) | All patients - Clinical cure (n=75, 84) | 75 Participants |
| Doripenem | Investigator Determined Clinical Response at TOC for Patients Infected by Ceftazidime-resistant Gram-negative Pathogen (mMITT Analysis Set) | Pseudomonas aeruginosa patients- Clin cure(n=7,6) | 6 Participants |
| Doripenem | Investigator Determined Clinical Response at TOC for Patients Infected by Ceftazidime-resistant Gram-negative Pathogen (mMITT Analysis Set) | Escherichia coli patients - Clin cure (n=36, 37) | 31 Participants |
| Doripenem | Investigator Determined Clinical Response at TOC for Patients Infected by Ceftazidime-resistant Gram-negative Pathogen (mMITT Analysis Set) | Proteus mirabilis patients - Clin cure (n=2, 5) | 5 Participants |
| Doripenem | Investigator Determined Clinical Response at TOC for Patients Infected by Ceftazidime-resistant Gram-negative Pathogen (mMITT Analysis Set) | Klebsiella pneumoniae patients-Clin cure(n=18,30) | 28 Participants |
Comparison: Confidence interval of the difference (CAZ-AVI treatment group minus Doripenem treatment group) of clinical cure rates in All patients with a ceftazidime-resistant Gram-negative pathogen95% CI: [-10.4, 10.1]Unstratified Miettinen & Nurminen method
Secondary
Investigator Determined Clinical Response at TOC (ME at TOC Analysis Set)
Number of patients with a clinical cure at TOC. The investigator should consider the entirety of the patient's clinical course and current status, including an evaluation of signs and symptoms (eg, fever, dysuria, costovertebral angle tenderness) and physical examination in order to classify the patient's clinical response.
Time frame: At TOC visit. TOC visit is 21 to 25 days from Randomization.
Population: Microbiological evaluable analysis set at TOC (ME at TOC )
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CAZ-AVI | Investigator Determined Clinical Response at TOC (ME at TOC Analysis Set) | Clinical cure | 277 Participants |
| CAZ-AVI | Investigator Determined Clinical Response at TOC (ME at TOC Analysis Set) | Clinical failure | 4 Participants |
| CAZ-AVI | Investigator Determined Clinical Response at TOC (ME at TOC Analysis Set) | Indeterminate | 5 Participants |
| Doripenem | Investigator Determined Clinical Response at TOC (ME at TOC Analysis Set) | Clinical cure | 285 Participants |
| Doripenem | Investigator Determined Clinical Response at TOC (ME at TOC Analysis Set) | Clinical failure | 13 Participants |
| Doripenem | Investigator Determined Clinical Response at TOC (ME at TOC Analysis Set) | Indeterminate | 0 Participants |
Comparison: Confidence interval of the difference (CAZ-AVI treatment group minus Doripenem treatment group) of clinical cure rates95% CI: [-2.03, 4.56]Unstratified Miettinen & Nurminen method
Secondary
Investigator Determined Clinical Response at TOC (mMITT Analysis Set)
Number of patients with a clinical cure at TOC. The investigator should consider the entirety of the patient's clinical course and current status, including an evaluation of signs and symptoms (eg, fever, dysuria, costovertebral angle tenderness) and physical examination in order to classify the patient's clinical response.
Time frame: At TOC visit. TOC visit is 21 to 25 days from Randomization.
Population: Microbiological modified intent to treat analysis set (mMITT)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CAZ-AVI | Investigator Determined Clinical Response at TOC (mMITT Analysis Set) | Clinical cure | 355 Participants |
| CAZ-AVI | Investigator Determined Clinical Response at TOC (mMITT Analysis Set) | Clinical failure | 11 Participants |
| CAZ-AVI | Investigator Determined Clinical Response at TOC (mMITT Analysis Set) | Indeterminate | 27 Participants |
| Doripenem | Investigator Determined Clinical Response at TOC (mMITT Analysis Set) | Clinical cure | 377 Participants |
| Doripenem | Investigator Determined Clinical Response at TOC (mMITT Analysis Set) | Clinical failure | 24 Participants |
| Doripenem | Investigator Determined Clinical Response at TOC (mMITT Analysis Set) | Indeterminate | 16 Participants |
Comparison: Confidence interval of the difference (CAZ-AVI treatment group minus Doripenem treatment group) of clinical cure rates95% CI: [-4.23, 4.03]Unstratified Miettinen & Nurminen method
Secondary
Per-pathogen Microbiological Response at EOT (IV) for Baseline Pathogen (Extended ME at EOT (IV) Analysis Set)
Number of favorable per-pathogen microbiological responses at the EOT (IV) visit in the Extended ME at EOT (IV) analysis set
Time frame: At EOT IV visit. EOT (IV) visit is Within 24 hours after completion of the last infusion of IV study therapy and on/before the first dose for oral study therapy
Population: Extended microbiological evaluable analysis set at EOT (IV) (EME at EOT (IV))
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CAZ-AVI | Per-pathogen Microbiological Response at EOT (IV) for Baseline Pathogen (Extended ME at EOT (IV) Analysis Set) | Klebsiella pneumoniae - Favorable (n=34, 49) | 34 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at EOT (IV) for Baseline Pathogen (Extended ME at EOT (IV) Analysis Set) | Enterobacter cloacae - Favorable (n= 9, 12) | 9 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at EOT (IV) for Baseline Pathogen (Extended ME at EOT (IV) Analysis Set) | Proteus mirabilis - Favorable (n=13, 11) | 13 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at EOT (IV) for Baseline Pathogen (Extended ME at EOT (IV) Analysis Set) | Pseudomonas aeruginosa - Favorable (n=18, 18) | 17 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at EOT (IV) for Baseline Pathogen (Extended ME at EOT (IV) Analysis Set) | Escherichia coli - Favorable (n=250, 274) | 250 Participant |
| Doripenem | Per-pathogen Microbiological Response at EOT (IV) for Baseline Pathogen (Extended ME at EOT (IV) Analysis Set) | Pseudomonas aeruginosa - Favorable (n=18, 18) | 17 Participant |
| Doripenem | Per-pathogen Microbiological Response at EOT (IV) for Baseline Pathogen (Extended ME at EOT (IV) Analysis Set) | Escherichia coli - Favorable (n=250, 274) | 274 Participant |
| Doripenem | Per-pathogen Microbiological Response at EOT (IV) for Baseline Pathogen (Extended ME at EOT (IV) Analysis Set) | Klebsiella pneumoniae - Favorable (n=34, 49) | 48 Participant |
| Doripenem | Per-pathogen Microbiological Response at EOT (IV) for Baseline Pathogen (Extended ME at EOT (IV) Analysis Set) | Proteus mirabilis - Favorable (n=13, 11) | 11 Participant |
| Doripenem | Per-pathogen Microbiological Response at EOT (IV) for Baseline Pathogen (Extended ME at EOT (IV) Analysis Set) | Enterobacter cloacae - Favorable (n= 9, 12) | 12 Participant |
Secondary
Per-pathogen Microbiological Response at EOT (IV) for Baseline Pathogen (ME at EOT (IV) Analysis Set)
Number of favorable per-pathogen microbiological responses at the EOT (IV) visit in the ME at EOT (IV) analysis set
Time frame: At EOT (IV) visit. EOT (IV) visit is Within 24 hours after completion of the last infusion of IV study therapy and on/before the first dose for oral study therapy
Population: Microbiological evaluable analysis set at EOT (IV) (ME at EOT (IV))
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CAZ-AVI | Per-pathogen Microbiological Response at EOT (IV) for Baseline Pathogen (ME at EOT (IV) Analysis Set) | Klebsiella pneumoniae - Favorable (n=33, 48) | 33 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at EOT (IV) for Baseline Pathogen (ME at EOT (IV) Analysis Set) | Enterobacter cloacae - Favorable (n= 9, 12) | 9 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at EOT (IV) for Baseline Pathogen (ME at EOT (IV) Analysis Set) | Proteus mirabilis - Favorable (n=13,11) | 13 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at EOT (IV) for Baseline Pathogen (ME at EOT (IV) Analysis Set) | Pseudomonas aeruginosa - Favorable (n=10, 15) | 9 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at EOT (IV) for Baseline Pathogen (ME at EOT (IV) Analysis Set) | Escherichia coli - Favorable (n=249, 270) | 249 Participant |
| Doripenem | Per-pathogen Microbiological Response at EOT (IV) for Baseline Pathogen (ME at EOT (IV) Analysis Set) | Pseudomonas aeruginosa - Favorable (n=10, 15) | 14 Participant |
| Doripenem | Per-pathogen Microbiological Response at EOT (IV) for Baseline Pathogen (ME at EOT (IV) Analysis Set) | Escherichia coli - Favorable (n=249, 270) | 270 Participant |
| Doripenem | Per-pathogen Microbiological Response at EOT (IV) for Baseline Pathogen (ME at EOT (IV) Analysis Set) | Klebsiella pneumoniae - Favorable (n=33, 48) | 47 Participant |
| Doripenem | Per-pathogen Microbiological Response at EOT (IV) for Baseline Pathogen (ME at EOT (IV) Analysis Set) | Proteus mirabilis - Favorable (n=13,11) | 11 Participant |
| Doripenem | Per-pathogen Microbiological Response at EOT (IV) for Baseline Pathogen (ME at EOT (IV) Analysis Set) | Enterobacter cloacae - Favorable (n= 9, 12) | 12 Participant |
Secondary
Per-pathogen Microbiological Response at EOT (IV) for Baseline Pathogen (mMITT Analysis Set)
Number of favorable per-pathogen microbiological responses at the EOT (IV) visit in the mMITT analysis set
Time frame: At EOT IV visit. EOT (IV) visit is Within 24 hours after completion of the last infusion of IV study therapy and on/before the first dose for oral study therapy
Population: Microbiological modified intent to treat analysis set (mMITT)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CAZ-AVI | Per-pathogen Microbiological Response at EOT (IV) for Baseline Pathogen (mMITT Analysis Set) | Klebsiella pneumoniae - Favorable (n=44, 56) | 41 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at EOT (IV) for Baseline Pathogen (mMITT Analysis Set) | Enterobacter cloacae - Favorable (n= 11,13) | 9 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at EOT (IV) for Baseline Pathogen (mMITT Analysis Set) | Proteus mirabilis - Favorable (n=17, 13) | 16 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at EOT (IV) for Baseline Pathogen (mMITT Analysis Set) | Pseudomonas aeruginosa - Favorable (n=18, 20) | 17 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at EOT (IV) for Baseline Pathogen (mMITT Analysis Set) | Escherichia coli - Favorable (n=292, 306) | 280 Participant |
| Doripenem | Per-pathogen Microbiological Response at EOT (IV) for Baseline Pathogen (mMITT Analysis Set) | Pseudomonas aeruginosa - Favorable (n=18, 20) | 18 Participant |
| Doripenem | Per-pathogen Microbiological Response at EOT (IV) for Baseline Pathogen (mMITT Analysis Set) | Escherichia coli - Favorable (n=292, 306) | 293 Participant |
| Doripenem | Per-pathogen Microbiological Response at EOT (IV) for Baseline Pathogen (mMITT Analysis Set) | Klebsiella pneumoniae - Favorable (n=44, 56) | 51 Participant |
| Doripenem | Per-pathogen Microbiological Response at EOT (IV) for Baseline Pathogen (mMITT Analysis Set) | Proteus mirabilis - Favorable (n=17, 13) | 11 Participant |
| Doripenem | Per-pathogen Microbiological Response at EOT (IV) for Baseline Pathogen (mMITT Analysis Set) | Enterobacter cloacae - Favorable (n= 11,13) | 13 Participant |
Secondary
Per-pathogen Microbiological Response at EOT (IV) for Blood Only (Extended ME at EOT (IV) Analysis Set)
Number of favorable per-pathogen microbiological responses at the EOT (IV) visit in the Extended ME at EOT (IV) analysis set for blood only
Time frame: At EOT IV visit. EOT (IV) visit is Within 24 hours after completion of the last infusion of IV study therapy and on/before the first dose for oral study therapy
Population: Extended microbiological evaluable analysis set at EOT (IV) (EME at EOT (IV))
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CAZ-AVI | Per-pathogen Microbiological Response at EOT (IV) for Blood Only (Extended ME at EOT (IV) Analysis Set) | Escherichia coli - Favorable (n=26, 24) | 26 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at EOT (IV) for Blood Only (Extended ME at EOT (IV) Analysis Set) | Klebsiella pneumoniae - Favorable (n=2, 1) | 1 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at EOT (IV) for Blood Only (Extended ME at EOT (IV) Analysis Set) | Proteus mirabilis - Favorable (n=1, 0) | 1 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at EOT (IV) for Blood Only (Extended ME at EOT (IV) Analysis Set) | Pseudomonas aeruginosa - Favorable (n=1, 2) | 1 Participant |
| Doripenem | Per-pathogen Microbiological Response at EOT (IV) for Blood Only (Extended ME at EOT (IV) Analysis Set) | Pseudomonas aeruginosa - Favorable (n=1, 2) | 2 Participant |
| Doripenem | Per-pathogen Microbiological Response at EOT (IV) for Blood Only (Extended ME at EOT (IV) Analysis Set) | Escherichia coli - Favorable (n=26, 24) | 24 Participant |
| Doripenem | Per-pathogen Microbiological Response at EOT (IV) for Blood Only (Extended ME at EOT (IV) Analysis Set) | Proteus mirabilis - Favorable (n=1, 0) | 0 Participant |
| Doripenem | Per-pathogen Microbiological Response at EOT (IV) for Blood Only (Extended ME at EOT (IV) Analysis Set) | Klebsiella pneumoniae - Favorable (n=2, 1) | 1 Participant |
Secondary
Per-pathogen Microbiological Response at EOT (IV) for Blood Only (ME at EOT (IV) Analysis Set)
Number of favorable per-pathogen microbiological responses at the EOT (IV) visit in the ME at EOT (IV) analysis set for blood only
Time frame: At EOT (IV) visit. EOT (IV) visit is Within 24 hours after completion of the last infusion of IV study therapy and on/before the first dose for oral study therapy
Population: Microbiological evaluable analysis set at EOT (IV) (ME at EOT (IV))
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CAZ-AVI | Per-pathogen Microbiological Response at EOT (IV) for Blood Only (ME at EOT (IV) Analysis Set) | Escherichia coli - Favorable (n=26, 24) | 26 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at EOT (IV) for Blood Only (ME at EOT (IV) Analysis Set) | Klebsiella pneumoniae - Favorable (n=2, 1) | 1 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at EOT (IV) for Blood Only (ME at EOT (IV) Analysis Set) | Proteus mirabilis - Favorable (n=1, 0) | 1 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at EOT (IV) for Blood Only (ME at EOT (IV) Analysis Set) | Pseudomonas aeruginosa - Favorable (n=1, 2) | 1 Participant |
| Doripenem | Per-pathogen Microbiological Response at EOT (IV) for Blood Only (ME at EOT (IV) Analysis Set) | Pseudomonas aeruginosa - Favorable (n=1, 2) | 2 Participant |
| Doripenem | Per-pathogen Microbiological Response at EOT (IV) for Blood Only (ME at EOT (IV) Analysis Set) | Escherichia coli - Favorable (n=26, 24) | 24 Participant |
| Doripenem | Per-pathogen Microbiological Response at EOT (IV) for Blood Only (ME at EOT (IV) Analysis Set) | Proteus mirabilis - Favorable (n=1, 0) | 0 Participant |
| Doripenem | Per-pathogen Microbiological Response at EOT (IV) for Blood Only (ME at EOT (IV) Analysis Set) | Klebsiella pneumoniae - Favorable (n=2, 1) | 1 Participant |
Secondary
Per-pathogen Microbiological Response at EOT (IV) for Blood Only (mMITT Analysis Set)
Number of favorable per-pathogen microbiological responses at the EOT (IV) visit in the mMITT analysis set for blood only
Time frame: At EOT IV visit. EOT (IV) visit is Within 24 hours after completion of the last infusion of IV study therapy and on/before the first dose for oral study therapy
Population: Microbiological modified intent to treat analysis set (mMITT)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CAZ-AVI | Per-pathogen Microbiological Response at EOT (IV) for Blood Only (mMITT Analysis Set) | Escherichia coli - Favorable (n=32, 28) | 31 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at EOT (IV) for Blood Only (mMITT Analysis Set) | Klebsiella pneumoniae - Favorable (n=4, 2) | 2 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at EOT (IV) for Blood Only (mMITT Analysis Set) | Proteus mirabilis - Favorable (n=1, 0) | 1 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at EOT (IV) for Blood Only (mMITT Analysis Set) | Pseudomonas aeruginosa - Favorable (n=1, 2) | 1 Participant |
| Doripenem | Per-pathogen Microbiological Response at EOT (IV) for Blood Only (mMITT Analysis Set) | Pseudomonas aeruginosa - Favorable (n=1, 2) | 2 Participant |
| Doripenem | Per-pathogen Microbiological Response at EOT (IV) for Blood Only (mMITT Analysis Set) | Escherichia coli - Favorable (n=32, 28) | 28 Participant |
| Doripenem | Per-pathogen Microbiological Response at EOT (IV) for Blood Only (mMITT Analysis Set) | Proteus mirabilis - Favorable (n=1, 0) | 0 Participant |
| Doripenem | Per-pathogen Microbiological Response at EOT (IV) for Blood Only (mMITT Analysis Set) | Klebsiella pneumoniae - Favorable (n=4, 2) | 2 Participant |
Secondary
Per-pathogen Microbiological Response at LFU for Baseline Pathogen (Extended ME at LFU Analysis Set)
Number of favorable per-pathogen microbiological responses at the LFU visit in the Extended ME at LFU analysis set
Time frame: At LFU visit. LFU visit is 45 to 52 days from Randomization.
Population: Extended microbiological evaluable analysis set at LFU (EME at LFU)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CAZ-AVI | Per-pathogen Microbiological Response at LFU for Baseline Pathogen (Extended ME at LFU Analysis Set) | Klebsiella pneumoniae - Favorable (n=31, 36) | 24 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at LFU for Baseline Pathogen (Extended ME at LFU Analysis Set) | Enterobacter cloacae - Favorable (n= 7, 11) | 5 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at LFU for Baseline Pathogen (Extended ME at LFU Analysis Set) | Proteus mirabilis - Favorable (n=11,5) | 11 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at LFU for Baseline Pathogen (Extended ME at LFU Analysis Set) | Pseudomonas aeruginosa - Favorable (n=12, 16) | 7 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at LFU for Baseline Pathogen (Extended ME at LFU Analysis Set) | Escherichia coli - Favorable (n=179, 198) | 129 Participant |
| Doripenem | Per-pathogen Microbiological Response at LFU for Baseline Pathogen (Extended ME at LFU Analysis Set) | Pseudomonas aeruginosa - Favorable (n=12, 16) | 9 Participant |
| Doripenem | Per-pathogen Microbiological Response at LFU for Baseline Pathogen (Extended ME at LFU Analysis Set) | Escherichia coli - Favorable (n=179, 198) | 131 Participant |
| Doripenem | Per-pathogen Microbiological Response at LFU for Baseline Pathogen (Extended ME at LFU Analysis Set) | Klebsiella pneumoniae - Favorable (n=31, 36) | 19 Participant |
| Doripenem | Per-pathogen Microbiological Response at LFU for Baseline Pathogen (Extended ME at LFU Analysis Set) | Proteus mirabilis - Favorable (n=11,5) | 1 Participant |
| Doripenem | Per-pathogen Microbiological Response at LFU for Baseline Pathogen (Extended ME at LFU Analysis Set) | Enterobacter cloacae - Favorable (n= 7, 11) | 8 Participant |
Secondary
Per-pathogen Microbiological Response at LFU for Baseline Pathogen (ME at LFU Analysis Set)
Number of favorable per-pathogen microbiological responses at the LFU visit in the ME at LFU analysis set
Time frame: At LFU visit. LFU visit is 45 to 52 days from Randomization.
Population: Microbiological evaluable analysis set at LFU (ME at LFU)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CAZ-AVI | Per-pathogen Microbiological Response at LFU for Baseline Pathogen (ME at LFU Analysis Set) | Proteus mirabilis - Favorable (n=11,5) | 11 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at LFU for Baseline Pathogen (ME at LFU Analysis Set) | Enterobacter cloacae - Favorable (n= 7, 11) | 5 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at LFU for Baseline Pathogen (ME at LFU Analysis Set) | Klebsiella pneumoniae - Favorable (n=30, 35) | 23 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at LFU for Baseline Pathogen (ME at LFU Analysis Set) | Pseudomonas aeruginosa - Favorable (n=8, 13) | 6 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at LFU for Baseline Pathogen (ME at LFU Analysis Set) | Escherichia coli - Favorable (n=179, 194) | 129 Participant |
| Doripenem | Per-pathogen Microbiological Response at LFU for Baseline Pathogen (ME at LFU Analysis Set) | Pseudomonas aeruginosa - Favorable (n=8, 13) | 8 Participant |
| Doripenem | Per-pathogen Microbiological Response at LFU for Baseline Pathogen (ME at LFU Analysis Set) | Escherichia coli - Favorable (n=179, 194) | 127 Participant |
| Doripenem | Per-pathogen Microbiological Response at LFU for Baseline Pathogen (ME at LFU Analysis Set) | Klebsiella pneumoniae - Favorable (n=30, 35) | 18 Participant |
| Doripenem | Per-pathogen Microbiological Response at LFU for Baseline Pathogen (ME at LFU Analysis Set) | Enterobacter cloacae - Favorable (n= 7, 11) | 8 Participant |
| Doripenem | Per-pathogen Microbiological Response at LFU for Baseline Pathogen (ME at LFU Analysis Set) | Proteus mirabilis - Favorable (n=11,5) | 1 Participant |
Secondary
Per-pathogen Microbiological Response at LFU for Baseline Pathogen (mMITT Analysis Set)
Number of favorable per-pathogen microbiological responses at the LFU visit in the mMITT analysis set
Time frame: At LFU visit. LFU visit is 45 to 52 days from Randomization
Population: Microbiological modified intent to treat analysis set (mMITT)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CAZ-AVI | Per-pathogen Microbiological Response at LFU for Baseline Pathogen (mMITT Analysis Set) | Klebsiella pneumoniae - Favorable (n=44, 56) | 32 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at LFU for Baseline Pathogen (mMITT Analysis Set) | Enterobacter cloacae - Favorable (n= 11,13) | 6 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at LFU for Baseline Pathogen (mMITT Analysis Set) | Proteus mirabilis - Favorable (n=17, 13) | 16 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at LFU for Baseline Pathogen (mMITT Analysis Set) | Pseudomonas aeruginosa - Favorable (n=18, 20) | 9 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at LFU for Baseline Pathogen (mMITT Analysis Set) | Escherichia coli - Favorable (n=292, 306) | 198 Participant |
| Doripenem | Per-pathogen Microbiological Response at LFU for Baseline Pathogen (mMITT Analysis Set) | Pseudomonas aeruginosa - Favorable (n=18, 20) | 13 Participant |
| Doripenem | Per-pathogen Microbiological Response at LFU for Baseline Pathogen (mMITT Analysis Set) | Escherichia coli - Favorable (n=292, 306) | 189 Participant |
| Doripenem | Per-pathogen Microbiological Response at LFU for Baseline Pathogen (mMITT Analysis Set) | Klebsiella pneumoniae - Favorable (n=44, 56) | 30 Participant |
| Doripenem | Per-pathogen Microbiological Response at LFU for Baseline Pathogen (mMITT Analysis Set) | Proteus mirabilis - Favorable (n=17, 13) | 6 Participant |
| Doripenem | Per-pathogen Microbiological Response at LFU for Baseline Pathogen (mMITT Analysis Set) | Enterobacter cloacae - Favorable (n= 11,13) | 9 Participant |
Secondary
Per-pathogen Microbiological Response at LFU for Blood Only (Extended ME at LFU Analysis Set)
Number of favorable per-pathogen microbiological responses at the LFU visit in the Extended ME at LFU analysis set for blood only
Time frame: At LFU visit. LFU visit is 45 to 52 days from Randomization.
Population: Extended microbiological evaluable analysis set at LFU (EME at LFU)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CAZ-AVI | Per-pathogen Microbiological Response at LFU for Blood Only (Extended ME at LFU Analysis Set) | Escherichia coli - Favorable (n=19, 18) | 19 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at LFU for Blood Only (Extended ME at LFU Analysis Set) | Klebsiella pneumoniae - Favorable (n=2, 1) | 2 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at LFU for Blood Only (Extended ME at LFU Analysis Set) | Proteus mirabilis - Favorable (n=1, 0) | 1 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at LFU for Blood Only (Extended ME at LFU Analysis Set) | Pseudomonas aeruginosa - Favorable (n=0, 1) | 0 Participant |
| Doripenem | Per-pathogen Microbiological Response at LFU for Blood Only (Extended ME at LFU Analysis Set) | Pseudomonas aeruginosa - Favorable (n=0, 1) | 1 Participant |
| Doripenem | Per-pathogen Microbiological Response at LFU for Blood Only (Extended ME at LFU Analysis Set) | Escherichia coli - Favorable (n=19, 18) | 17 Participant |
| Doripenem | Per-pathogen Microbiological Response at LFU for Blood Only (Extended ME at LFU Analysis Set) | Proteus mirabilis - Favorable (n=1, 0) | 0 Participant |
| Doripenem | Per-pathogen Microbiological Response at LFU for Blood Only (Extended ME at LFU Analysis Set) | Klebsiella pneumoniae - Favorable (n=2, 1) | 1 Participant |
Secondary
Per-pathogen Microbiological Response at LFU for Blood Only (ME at LFU Analysis Set)
Number of favorable per-pathogen microbiological responses at the LFU visit in the ME at LFU analysis set for blood only
Time frame: At LFU visit. LFU visit is 45 to 52 days from Randomization.
Population: Microbiological evaluable analysis set at LFU (ME at LFU)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CAZ-AVI | Per-pathogen Microbiological Response at LFU for Blood Only (ME at LFU Analysis Set) | Escherichia coli - Favorable (n=19, 18) | 19 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at LFU for Blood Only (ME at LFU Analysis Set) | Klebsiella pneumoniae - Favorable (n=2, 1) | 2 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at LFU for Blood Only (ME at LFU Analysis Set) | Proteus mirabilis - Favorable (n=1, 0) | 1 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at LFU for Blood Only (ME at LFU Analysis Set) | Pseudomonas aeruginosa - Favorable (n=0, 1) | 0 Participant |
| Doripenem | Per-pathogen Microbiological Response at LFU for Blood Only (ME at LFU Analysis Set) | Pseudomonas aeruginosa - Favorable (n=0, 1) | 1 Participant |
| Doripenem | Per-pathogen Microbiological Response at LFU for Blood Only (ME at LFU Analysis Set) | Escherichia coli - Favorable (n=19, 18) | 17 Participant |
| Doripenem | Per-pathogen Microbiological Response at LFU for Blood Only (ME at LFU Analysis Set) | Proteus mirabilis - Favorable (n=1, 0) | 0 Participant |
| Doripenem | Per-pathogen Microbiological Response at LFU for Blood Only (ME at LFU Analysis Set) | Klebsiella pneumoniae - Favorable (n=2, 1) | 1 Participant |
Secondary
Per-pathogen Microbiological Response at LFU for Blood Only (mMITT Analysis Set)
Number of favorable per-pathogen microbiological responses at the LFU visit in the mMITT analysis set for blood only
Time frame: At LFU visit. LFU visit is 45 to 52 days from Randomization
Population: Microbiological modified intent to treat analysis set (mMITT)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CAZ-AVI | Per-pathogen Microbiological Response at LFU for Blood Only (mMITT Analysis Set) | Escherichia coli - Favorable (n=32, 28) | 29 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at LFU for Blood Only (mMITT Analysis Set) | Klebsiella pneumoniae - Favorable (n=4, 2) | 3 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at LFU for Blood Only (mMITT Analysis Set) | Proteus mirabilis - Favorable (n=1, 0) | 1 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at LFU for Blood Only (mMITT Analysis Set) | Pseudomonas aeruginosa - Favorable (n=1, 2) | 1 Participant |
| Doripenem | Per-pathogen Microbiological Response at LFU for Blood Only (mMITT Analysis Set) | Pseudomonas aeruginosa - Favorable (n=1, 2) | 2 Participant |
| Doripenem | Per-pathogen Microbiological Response at LFU for Blood Only (mMITT Analysis Set) | Escherichia coli - Favorable (n=32, 28) | 27 Participant |
| Doripenem | Per-pathogen Microbiological Response at LFU for Blood Only (mMITT Analysis Set) | Proteus mirabilis - Favorable (n=1, 0) | 0 Participant |
| Doripenem | Per-pathogen Microbiological Response at LFU for Blood Only (mMITT Analysis Set) | Klebsiella pneumoniae - Favorable (n=4, 2) | 2 Participant |
Secondary
Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (Extended ME at TOC Analysis Set)
Per pathogen microbiological response at TOC by CAZ-AVI MIC for baseline pathogen in the Extended ME at TOC analysis set
Time frame: At TOC visit. TOC visit is 21 to 25 days from Randomization
Population: Extended microbiological evaluable analysis set at TOC (EME at TOC)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (Extended ME at TOC Analysis Set) | Proteus mirabilis (MIC: 1)- Favorable (n=0, 0) | 0 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (Extended ME at TOC Analysis Set) | Kleb.pneumoniae (MIC: 0.12) -Favorable(n=8, 9) | 7 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (Extended ME at TOC Analysis Set) | Proteus mirabilis (MIC: 2)- Favorable (n=0, 0) | 0 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (Extended ME at TOC Analysis Set) | E. coli (MIC: 0.25) - Favorable (n=19, 18) | 13 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (Extended ME at TOC Analysis Set) | Proteus mirabilis (MIC: 4)- Favorable (n=0, 0) | 0 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (Extended ME at TOC Analysis Set) | Kleb. pneumoniae (MIC: 0.25) - Favorable (n=3, 7) | 1 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (Extended ME at TOC Analysis Set) | Proteus mirabilis (MIC: 8)- Favorable (n=0, 0) | 0 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (Extended ME at TOC Analysis Set) | E. coli (MIC: 8) - Favorable (n=0, 0) | 0 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (Extended ME at TOC Analysis Set) | Proteus mirabilis (MIC: 16)- Favorable (n=0, 0) | 0 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (Extended ME at TOC Analysis Set) | Kleb. pneumoniae (MIC: 0.5) - Favorable (n=6, 11) | 4 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (Extended ME at TOC Analysis Set) | Proteus mirabilis (MIC: 32)- Favorable (n=0, 0) | 0 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (Extended ME at TOC Analysis Set) | E. coli (MIC: 0.06) - Favorable (n=95, 111) | 83 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (Extended ME at TOC Analysis Set) | Proteus mirabilis (MIC: >32)- Favorable (n=0, 0) | 0 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (Extended ME at TOC Analysis Set) | Kleb. pneumoniae (MIC: 1) - Favorable (n=6, 4) | 6 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (Extended ME at TOC Analysis Set) | Entero. cloacae (MIC: <=0.008)- Favorable (n= 0,0) | 0 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (Extended ME at TOC Analysis Set) | E. coli (MIC: 16) - Favorable (n=0, 0) | 0 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (Extended ME at TOC Analysis Set) | Entero. cloacae (MIC: 0.015)- Favorable (n= 0,0) | 0 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (Extended ME at TOC Analysis Set) | Kleb. pneumoniae (MIC: 2) - Favorable (n= 2, 1) | 2 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (Extended ME at TOC Analysis Set) | Entero. cloacae (MIC: 0.03)- Favorable (n= 1,0) | 1 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (Extended ME at TOC Analysis Set) | E. coli (MIC: 0.5) - Favorable (n=2, 5) | 2 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (Extended ME at TOC Analysis Set) | Entero. cloacae (MIC: 0.06)- Favorable (n= 0, 1) | 0 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (Extended ME at TOC Analysis Set) | Kleb. pneumoniae (MIC: 4) - Favorable (n=0, 0) | 0 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (Extended ME at TOC Analysis Set) | Entero. cloacae (MIC: 0.12)- Favorable (n= 1,2) | 1 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (Extended ME at TOC Analysis Set) | E. coli (MIC: 32) - Favorable (n=0, 0) | 0 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (Extended ME at TOC Analysis Set) | Entero. cloacae (MIC: 0.25)- Favorable (n= 0,3) | 0 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (Extended ME at TOC Analysis Set) | Kleb. pneumoniae (MIC: 8) - Favorable (n=0, 0) | 0 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (Extended ME at TOC Analysis Set) | Entero. cloacae (MIC: 0.5)- Favorable (n= 1,1) | 0 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (Extended ME at TOC Analysis Set) | E. coli (MIC: 0.03) - Favorable (n=18, 21) | 17 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (Extended ME at TOC Analysis Set) | Entero. cloacae (MIC: 1)- Favorable (n= 1,4) | 1 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (Extended ME at TOC Analysis Set) | Kleb. pneumoniae (MIC: 16) - Favorable (n=0, 0) | 0 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (Extended ME at TOC Analysis Set) | Entero. cloacae (MIC: 2)- Favorable (n= 1,0) | 1 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (Extended ME at TOC Analysis Set) | E. coli (MIC: >32) - Favorable (n=0, 0) | 0 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (Extended ME at TOC Analysis Set) | Entero. cloacae (MIC: 4)- Favorable (n= 2,0) | 1 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (Extended ME at TOC Analysis Set) | Kleb. pneumoniae (MIC: 32) - Favorable (n=0, 0) | 0 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (Extended ME at TOC Analysis Set) | Entero. cloacae (MIC: 8)- Favorable (n= 0,0) | 0 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (Extended ME at TOC Analysis Set) | E. coli (MIC: 1) - Favorable (n=2, 0) | 1 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (Extended ME at TOC Analysis Set) | Entero. cloacae (MIC: 16)- Favorable (n= 0,0) | 0 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (Extended ME at TOC Analysis Set) | Kleb. pneumoniae (MIC: >32) - Favorable (n=0, 1) | 0 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (Extended ME at TOC Analysis Set) | Entero. cloacae (MIC: 32)- Favorable (n= 0,0) | 0 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (Extended ME at TOC Analysis Set) | Kleb.pneumoniae (MIC: <=0.008)-Favorable(n=0, 0) | 0 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (Extended ME at TOC Analysis Set) | Entero. cloacae (MIC: >32)- Favorable (n= 0,0) | 0 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (Extended ME at TOC Analysis Set) | Proteus mirabilis (MIC:<=0.008)- Favorable (n=0,0) | 0 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (Extended ME at TOC Analysis Set) | P.aeruginosa (MIC: <=0.008) - Favorable (n=0,0) | 0 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (Extended ME at TOC Analysis Set) | E. coli (MIC: 0.12) - Favorable (n=68, 54) | 56 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (Extended ME at TOC Analysis Set) | P.aeruginosa (MIC: 0.015) - Favorable (n=0,0) | 0 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (Extended ME at TOC Analysis Set) | Proteus mirabilis (MIC: 0.015)- Favorable (n=1,0) | 1 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (Extended ME at TOC Analysis Set) | P.aeruginosa (MIC: 0.03) - Favorable (n=0,0) | 0 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (Extended ME at TOC Analysis Set) | Kleb. pneumoniae (MIC: 0.015) - Favorable (n=1, 0) | 1 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (Extended ME at TOC Analysis Set) | P.aeruginosa (MIC: 0.06) - Favorable (n=0,0) | 0 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (Extended ME at TOC Analysis Set) | Proteus mirabilis (MIC: 0.03)- Favorable (n=9, 2) | 9 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (Extended ME at TOC Analysis Set) | P.aeruginosa (MIC: 0.12) - Favorable (n=0,0) | 0 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (Extended ME at TOC Analysis Set) | E. coli (MIC: 2) - Favorable (n=1, 0) | 1 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (Extended ME at TOC Analysis Set) | P.aeruginosa (MIC: 0.25) - Favorable (n=0,0) | 0 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (Extended ME at TOC Analysis Set) | Proteus mirabilis (MIC: 0.06)- Favorable (n=4,5) | 4 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (Extended ME at TOC Analysis Set) | P.aeruginosa (MIC: 0.5) - Favorable (n=0,0) | 0 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (Extended ME at TOC Analysis Set) | Kleb. pneumoniae (MIC: 0.03) - Favorable (n=1, 2) | 1 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (Extended ME at TOC Analysis Set) | P.aeruginosa (MIC: 1) - Favorable (n=1,4) | 1 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (Extended ME at TOC Analysis Set) | Proteus mirabilis (MIC: 0.12)- Favorable (n=0,0) | 0 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (Extended ME at TOC Analysis Set) | P.aeruginosa (MIC: 2) - Favorable (n=4,5) | 4 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (Extended ME at TOC Analysis Set) | E. coli (MIC: 0.015) - Favorable (n=5, 6) | 5 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (Extended ME at TOC Analysis Set) | P.aeruginosa (MIC: 4) - Favorable (n=5,6) | 1 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (Extended ME at TOC Analysis Set) | Proteus mirabilis (MIC: 0.25)- Favorable (n=0, 0) | 0 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (Extended ME at TOC Analysis Set) | P.aeruginosa (MIC: 8) - Favorable (n=2,2) | 1 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (Extended ME at TOC Analysis Set) | Kleb. pneumoniae (MIC: 0.06) - Favorable (n=5, 7) | 4 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (Extended ME at TOC Analysis Set) | P.aeruginosa (MIC: 16) - Favorable (n=0,1) | 0 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (Extended ME at TOC Analysis Set) | Proteus mirabilis (MIC: 0.5)- Favorable (n=0,0) | 0 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (Extended ME at TOC Analysis Set) | P.aeruginosa (MIC: 32) - Favorable (n=0,0) | 0 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (Extended ME at TOC Analysis Set) | E. coli (MIC: 4) - Favorable (n=0, 0) | 0 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (Extended ME at TOC Analysis Set) | P.aeruginosa (MIC: >32) - Favorable (n=1,0) | 1 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (Extended ME at TOC Analysis Set) | E. coli (MIC: <=0.008) - Favorable (n=4,4) | 2 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (Extended ME at TOC Analysis Set) | P.aeruginosa (MIC: >32) - Favorable (n=1,0) | 0 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (Extended ME at TOC Analysis Set) | E. coli (MIC: <=0.008) - Favorable (n=4,4) | 4 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (Extended ME at TOC Analysis Set) | E. coli (MIC: 0.015) - Favorable (n=5, 6) | 5 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (Extended ME at TOC Analysis Set) | E. coli (MIC: 0.03) - Favorable (n=18, 21) | 17 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (Extended ME at TOC Analysis Set) | E. coli (MIC: 0.06) - Favorable (n=95, 111) | 94 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (Extended ME at TOC Analysis Set) | E. coli (MIC: 0.12) - Favorable (n=68, 54) | 40 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (Extended ME at TOC Analysis Set) | E. coli (MIC: 0.25) - Favorable (n=19, 18) | 8 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (Extended ME at TOC Analysis Set) | E. coli (MIC: 0.5) - Favorable (n=2, 5) | 2 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (Extended ME at TOC Analysis Set) | E. coli (MIC: 1) - Favorable (n=2, 0) | 0 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (Extended ME at TOC Analysis Set) | E. coli (MIC: 2) - Favorable (n=1, 0) | 0 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (Extended ME at TOC Analysis Set) | E. coli (MIC: 4) - Favorable (n=0, 0) | 0 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (Extended ME at TOC Analysis Set) | E. coli (MIC: 8) - Favorable (n=0, 0) | 0 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (Extended ME at TOC Analysis Set) | E. coli (MIC: 16) - Favorable (n=0, 0) | 0 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (Extended ME at TOC Analysis Set) | E. coli (MIC: 32) - Favorable (n=0, 0) | 0 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (Extended ME at TOC Analysis Set) | E. coli (MIC: >32) - Favorable (n=0, 0) | 0 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (Extended ME at TOC Analysis Set) | Kleb.pneumoniae (MIC: <=0.008)-Favorable(n=0, 0) | 0 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (Extended ME at TOC Analysis Set) | Kleb. pneumoniae (MIC: 0.015) - Favorable (n=1, 0) | 0 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (Extended ME at TOC Analysis Set) | Kleb. pneumoniae (MIC: 0.03) - Favorable (n=1, 2) | 2 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (Extended ME at TOC Analysis Set) | Kleb. pneumoniae (MIC: 0.06) - Favorable (n=5, 7) | 7 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (Extended ME at TOC Analysis Set) | Kleb.pneumoniae (MIC: 0.12) -Favorable(n=8, 9) | 6 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (Extended ME at TOC Analysis Set) | Kleb. pneumoniae (MIC: 0.25) - Favorable (n=3, 7) | 2 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (Extended ME at TOC Analysis Set) | Kleb. pneumoniae (MIC: 0.5) - Favorable (n=6, 11) | 8 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (Extended ME at TOC Analysis Set) | Kleb. pneumoniae (MIC: 1) - Favorable (n=6, 4) | 3 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (Extended ME at TOC Analysis Set) | Kleb. pneumoniae (MIC: 2) - Favorable (n= 2, 1) | 0 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (Extended ME at TOC Analysis Set) | Kleb. pneumoniae (MIC: 4) - Favorable (n=0, 0) | 0 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (Extended ME at TOC Analysis Set) | Kleb. pneumoniae (MIC: 8) - Favorable (n=0, 0) | 0 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (Extended ME at TOC Analysis Set) | Kleb. pneumoniae (MIC: 16) - Favorable (n=0, 0) | 0 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (Extended ME at TOC Analysis Set) | Kleb. pneumoniae (MIC: 32) - Favorable (n=0, 0) | 0 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (Extended ME at TOC Analysis Set) | Kleb. pneumoniae (MIC: >32) - Favorable (n=0, 1) | 1 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (Extended ME at TOC Analysis Set) | Proteus mirabilis (MIC:<=0.008)- Favorable (n=0,0) | 0 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (Extended ME at TOC Analysis Set) | Proteus mirabilis (MIC: 0.015)- Favorable (n=1,0) | 0 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (Extended ME at TOC Analysis Set) | Proteus mirabilis (MIC: 0.03)- Favorable (n=9, 2) | 0 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (Extended ME at TOC Analysis Set) | Proteus mirabilis (MIC: 0.06)- Favorable (n=4,5) | 4 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (Extended ME at TOC Analysis Set) | Proteus mirabilis (MIC: 0.12)- Favorable (n=0,0) | 0 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (Extended ME at TOC Analysis Set) | Proteus mirabilis (MIC: 0.25)- Favorable (n=0, 0) | 0 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (Extended ME at TOC Analysis Set) | Proteus mirabilis (MIC: 0.5)- Favorable (n=0,0) | 0 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (Extended ME at TOC Analysis Set) | Proteus mirabilis (MIC: 1)- Favorable (n=0, 0) | 0 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (Extended ME at TOC Analysis Set) | Proteus mirabilis (MIC: 2)- Favorable (n=0, 0) | 0 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (Extended ME at TOC Analysis Set) | Proteus mirabilis (MIC: 4)- Favorable (n=0, 0) | 0 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (Extended ME at TOC Analysis Set) | Proteus mirabilis (MIC: 8)- Favorable (n=0, 0) | 0 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (Extended ME at TOC Analysis Set) | Proteus mirabilis (MIC: 16)- Favorable (n=0, 0) | 0 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (Extended ME at TOC Analysis Set) | Proteus mirabilis (MIC: 32)- Favorable (n=0, 0) | 0 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (Extended ME at TOC Analysis Set) | Proteus mirabilis (MIC: >32)- Favorable (n=0, 0) | 0 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (Extended ME at TOC Analysis Set) | Entero. cloacae (MIC: <=0.008)- Favorable (n= 0,0) | 0 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (Extended ME at TOC Analysis Set) | Entero. cloacae (MIC: 0.015)- Favorable (n= 0,0) | 0 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (Extended ME at TOC Analysis Set) | Entero. cloacae (MIC: 0.03)- Favorable (n= 1,0) | 0 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (Extended ME at TOC Analysis Set) | Entero. cloacae (MIC: 0.06)- Favorable (n= 0, 1) | 1 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (Extended ME at TOC Analysis Set) | Entero. cloacae (MIC: 0.12)- Favorable (n= 1,2) | 2 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (Extended ME at TOC Analysis Set) | Entero. cloacae (MIC: 0.25)- Favorable (n= 0,3) | 0 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (Extended ME at TOC Analysis Set) | Entero. cloacae (MIC: 0.5)- Favorable (n= 1,1) | 1 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (Extended ME at TOC Analysis Set) | Entero. cloacae (MIC: 1)- Favorable (n= 1,4) | 4 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (Extended ME at TOC Analysis Set) | Entero. cloacae (MIC: 2)- Favorable (n= 1,0) | 0 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (Extended ME at TOC Analysis Set) | Entero. cloacae (MIC: 4)- Favorable (n= 2,0) | 0 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (Extended ME at TOC Analysis Set) | Entero. cloacae (MIC: 8)- Favorable (n= 0,0) | 0 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (Extended ME at TOC Analysis Set) | Entero. cloacae (MIC: 16)- Favorable (n= 0,0) | 0 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (Extended ME at TOC Analysis Set) | Entero. cloacae (MIC: 32)- Favorable (n= 0,0) | 0 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (Extended ME at TOC Analysis Set) | Entero. cloacae (MIC: >32)- Favorable (n= 0,0) | 0 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (Extended ME at TOC Analysis Set) | P.aeruginosa (MIC: <=0.008) - Favorable (n=0,0) | 0 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (Extended ME at TOC Analysis Set) | P.aeruginosa (MIC: 0.015) - Favorable (n=0,0) | 0 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (Extended ME at TOC Analysis Set) | P.aeruginosa (MIC: 0.03) - Favorable (n=0,0) | 0 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (Extended ME at TOC Analysis Set) | P.aeruginosa (MIC: 0.06) - Favorable (n=0,0) | 0 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (Extended ME at TOC Analysis Set) | P.aeruginosa (MIC: 0.12) - Favorable (n=0,0) | 0 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (Extended ME at TOC Analysis Set) | P.aeruginosa (MIC: 0.25) - Favorable (n=0,0) | 0 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (Extended ME at TOC Analysis Set) | P.aeruginosa (MIC: 0.5) - Favorable (n=0,0) | 0 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (Extended ME at TOC Analysis Set) | P.aeruginosa (MIC: 1) - Favorable (n=1,4) | 2 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (Extended ME at TOC Analysis Set) | P.aeruginosa (MIC: 2) - Favorable (n=4,5) | 5 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (Extended ME at TOC Analysis Set) | P.aeruginosa (MIC: 4) - Favorable (n=5,6) | 4 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (Extended ME at TOC Analysis Set) | P.aeruginosa (MIC: 8) - Favorable (n=2,2) | 1 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (Extended ME at TOC Analysis Set) | P.aeruginosa (MIC: 16) - Favorable (n=0,1) | 1 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (Extended ME at TOC Analysis Set) | P.aeruginosa (MIC: 32) - Favorable (n=0,0) | 0 Participant |
Secondary
Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (ME at TOC Analysis Set)
Per pathogen microbiological response at TOC by CAZ-AVI MIC for baseline pathogen in the ME at TOC analysis set
Time frame: At TOC visit. TOC visit is 21 to 25 days from Randomization
Population: Microbiological evaluable analysis set at TOC (ME at TOC)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (ME at TOC Analysis Set) | Proteus mirabilis (MIC: 1)- Favorable (n=0, 0) | 0 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (ME at TOC Analysis Set) | Kleb.pneumoniae (MIC: 0.12) -Favorable(n=8, 9) | 7 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (ME at TOC Analysis Set) | Proteus mirabilis (MIC: 2)- Favorable (n=0, 0) | 0 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (ME at TOC Analysis Set) | E. coli (MIC: 0.25) - Favorable (n=19, 18) | 13 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (ME at TOC Analysis Set) | Proteus mirabilis (MIC: 4)- Favorable (n=0, 0) | 0 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (ME at TOC Analysis Set) | Kleb. pneumoniae (MIC: 0.25) - Favorable (n=3, 7) | 1 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (ME at TOC Analysis Set) | Proteus mirabilis (MIC: 8)- Favorable (n=0, 0) | 0 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (ME at TOC Analysis Set) | E. coli (MIC: 8) - Favorable (n=0, 0) | 0 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (ME at TOC Analysis Set) | Proteus mirabilis (MIC: 16)- Favorable (n=0, 0) | 0 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (ME at TOC Analysis Set) | Kleb. pneumoniae (MIC: 0.5) - Favorable (n=6, 11) | 4 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (ME at TOC Analysis Set) | Proteus mirabilis (MIC: 32)- Favorable (n=0, 0) | 0 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (ME at TOC Analysis Set) | E. coli (MIC: 0.06) - Favorable (n=95, 111) | 83 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (ME at TOC Analysis Set) | Proteus mirabilis (MIC: >32)- Favorable (n=0, 0) | 0 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (ME at TOC Analysis Set) | Kleb. pneumoniae (MIC: 1) - Favorable (n=5, 4) | 5 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (ME at TOC Analysis Set) | Entero. cloacae (MIC: <=0.008)- Favorable (n= 0,0) | 0 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (ME at TOC Analysis Set) | E. coli (MIC: 16) - Favorable (n=0, 0) | 0 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (ME at TOC Analysis Set) | Entero. cloacae (MIC: 0.015)- Favorable (n= 0,0) | 0 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (ME at TOC Analysis Set) | Kleb. pneumoniae (MIC: 2) - Favorable (n= 2, 1) | 2 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (ME at TOC Analysis Set) | Entero. cloacae (MIC: 0.03)- Favorable (n= 1,0) | 1 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (ME at TOC Analysis Set) | E. coli (MIC: 0.5) - Favorable (n=2, 5) | 2 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (ME at TOC Analysis Set) | Entero. cloacae (MIC: 0.06)- Favorable (n= 0, 1) | 0 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (ME at TOC Analysis Set) | Kleb. pneumoniae (MIC: 4) - Favorable (n=0, 0) | 0 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (ME at TOC Analysis Set) | Entero. cloacae (MIC: 0.12)- Favorable (n= 1,2) | 1 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (ME at TOC Analysis Set) | E. coli (MIC: 32) - Favorable (n=0, 0) | 0 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (ME at TOC Analysis Set) | Entero. cloacae (MIC: 0.25)- Favorable (n= 0,3) | 0 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (ME at TOC Analysis Set) | Kleb. pneumoniae (MIC: 8) - Favorable (n=0, 0) | 0 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (ME at TOC Analysis Set) | Entero. cloacae (MIC: 0.5)- Favorable (n= 1,1) | 0 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (ME at TOC Analysis Set) | E. coli (MIC: 0.03) - Favorable (n=18, 21) | 17 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (ME at TOC Analysis Set) | Entero. cloacae (MIC: 1)- Favorable (n= 1,4) | 1 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (ME at TOC Analysis Set) | Kleb. pneumoniae (MIC: 16) - Favorable (n=0, 0) | 0 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (ME at TOC Analysis Set) | Entero. cloacae (MIC: 2)- Favorable (n= 1,0) | 1 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (ME at TOC Analysis Set) | E. coli (MIC: >32) - Favorable (n=0, 0) | 0 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (ME at TOC Analysis Set) | Entero. cloacae (MIC: 4)- Favorable (n= 2,0) | 1 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (ME at TOC Analysis Set) | Kleb. pneumoniae (MIC: 32) - Favorable (n=0, 0) | 0 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (ME at TOC Analysis Set) | Entero. cloacae (MIC: 8)- Favorable (n= 0,0) | 0 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (ME at TOC Analysis Set) | E. coli (MIC: 1) - Favorable (n=2, 0) | 1 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (ME at TOC Analysis Set) | Entero. cloacae (MIC: 16)- Favorable (n= 0,0) | 0 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (ME at TOC Analysis Set) | Kleb. pneumoniae (MIC: >32) - Favorable (n=0, 0) | 0 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (ME at TOC Analysis Set) | Entero. cloacae (MIC: 32)- Favorable (n= 0,0) | 0 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (ME at TOC Analysis Set) | Kleb.pneumoniae (MIC: <=0.008)-Favorable(n=0, 0) | 0 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (ME at TOC Analysis Set) | Entero. cloacae (MIC: >32)- Favorable (n= 0,0) | 0 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (ME at TOC Analysis Set) | Proteus mirabilis (MIC:<=0.008)- Favorable (n=0,0) | 0 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (ME at TOC Analysis Set) | P.aeruginosa (MIC: <=0.008) - Favorable (n=0,0) | 0 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (ME at TOC Analysis Set) | E. coli (MIC: 0.12) - Favorable (n=68, 54) | 56 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (ME at TOC Analysis Set) | P.aeruginosa (MIC: 0.015) - Favorable (n=0,0) | 0 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (ME at TOC Analysis Set) | Proteus mirabilis (MIC: 0.015)- Favorable (n=1,0) | 1 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (ME at TOC Analysis Set) | P.aeruginosa (MIC: 0.03) - Favorable (n=0,0) | 0 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (ME at TOC Analysis Set) | Kleb. pneumoniae (MIC: 0.015) - Favorable (n=1, 0) | 1 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (ME at TOC Analysis Set) | P.aeruginosa (MIC: 0.06) - Favorable (n=0,0) | 0 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (ME at TOC Analysis Set) | Proteus mirabilis (MIC: 0.03)- Favorable (n=9, 2) | 9 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (ME at TOC Analysis Set) | P.aeruginosa (MIC: 0.12) - Favorable (n=0,0) | 0 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (ME at TOC Analysis Set) | E. coli (MIC: 2) - Favorable (n=1, 0) | 1 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (ME at TOC Analysis Set) | P.aeruginosa (MIC: 0.25) - Favorable (n=0,0) | 0 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (ME at TOC Analysis Set) | Proteus mirabilis (MIC: 0.06)- Favorable (n=4,5) | 4 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (ME at TOC Analysis Set) | P.aeruginosa (MIC: 0.5) - Favorable (n=0,0) | 0 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (ME at TOC Analysis Set) | Kleb. pneumoniae (MIC: 0.03) - Favorable (n=1, 2) | 1 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (ME at TOC Analysis Set) | P.aeruginosa (MIC: 1) - Favorable (n=1,4) | 1 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (ME at TOC Analysis Set) | Proteus mirabilis (MIC: 0.12)- Favorable (n=0,0) | 0 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (ME at TOC Analysis Set) | P.aeruginosa (MIC: 2) - Favorable (n=4,4) | 4 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (ME at TOC Analysis Set) | E. coli (MIC: 0.015) - Favorable (n=5, 6) | 5 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (ME at TOC Analysis Set) | P.aeruginosa (MIC: 4) - Favorable (n=3,4) | 1 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (ME at TOC Analysis Set) | Proteus mirabilis (MIC: 0.25)- Favorable (n=0, 0) | 0 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (ME at TOC Analysis Set) | P.aeruginosa (MIC: 8) - Favorable (n=1,1) | 1 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (ME at TOC Analysis Set) | Kleb. pneumoniae (MIC: 0.06) - Favorable (n=5, 7) | 4 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (ME at TOC Analysis Set) | P.aeruginosa (MIC: 16) - Favorable (n=0,0) | 0 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (ME at TOC Analysis Set) | Proteus mirabilis (MIC: 0.5)- Favorable (n=0,0) | 0 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (ME at TOC Analysis Set) | P.aeruginosa (MIC: 32) - Favorable (n=0,0) | 0 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (ME at TOC Analysis Set) | E. coli (MIC: 4) - Favorable (n=0, 0) | 0 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (ME at TOC Analysis Set) | P.aeruginosa (MIC: >32) - Favorable (n=0,0) | 0 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (ME at TOC Analysis Set) | E. coli (MIC: <=0.008) - Favorable (n=4,4) | 2 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (ME at TOC Analysis Set) | P.aeruginosa (MIC: >32) - Favorable (n=0,0) | 0 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (ME at TOC Analysis Set) | E. coli (MIC: <=0.008) - Favorable (n=4,4) | 4 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (ME at TOC Analysis Set) | E. coli (MIC: 0.015) - Favorable (n=5, 6) | 5 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (ME at TOC Analysis Set) | E. coli (MIC: 0.03) - Favorable (n=18, 21) | 17 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (ME at TOC Analysis Set) | E. coli (MIC: 0.06) - Favorable (n=95, 111) | 94 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (ME at TOC Analysis Set) | E. coli (MIC: 0.12) - Favorable (n=68, 54) | 40 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (ME at TOC Analysis Set) | E. coli (MIC: 0.25) - Favorable (n=19, 18) | 8 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (ME at TOC Analysis Set) | E. coli (MIC: 0.5) - Favorable (n=2, 5) | 2 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (ME at TOC Analysis Set) | E. coli (MIC: 1) - Favorable (n=2, 0) | 0 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (ME at TOC Analysis Set) | E. coli (MIC: 2) - Favorable (n=1, 0) | 0 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (ME at TOC Analysis Set) | E. coli (MIC: 4) - Favorable (n=0, 0) | 0 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (ME at TOC Analysis Set) | E. coli (MIC: 8) - Favorable (n=0, 0) | 0 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (ME at TOC Analysis Set) | E. coli (MIC: 16) - Favorable (n=0, 0) | 0 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (ME at TOC Analysis Set) | E. coli (MIC: 32) - Favorable (n=0, 0) | 0 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (ME at TOC Analysis Set) | E. coli (MIC: >32) - Favorable (n=0, 0) | 0 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (ME at TOC Analysis Set) | Kleb.pneumoniae (MIC: <=0.008)-Favorable(n=0, 0) | 0 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (ME at TOC Analysis Set) | Kleb. pneumoniae (MIC: 0.015) - Favorable (n=1, 0) | 0 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (ME at TOC Analysis Set) | Kleb. pneumoniae (MIC: 0.03) - Favorable (n=1, 2) | 2 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (ME at TOC Analysis Set) | Kleb. pneumoniae (MIC: 0.06) - Favorable (n=5, 7) | 7 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (ME at TOC Analysis Set) | Kleb.pneumoniae (MIC: 0.12) -Favorable(n=8, 9) | 6 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (ME at TOC Analysis Set) | Kleb. pneumoniae (MIC: 0.25) - Favorable (n=3, 7) | 2 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (ME at TOC Analysis Set) | Kleb. pneumoniae (MIC: 0.5) - Favorable (n=6, 11) | 8 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (ME at TOC Analysis Set) | Kleb. pneumoniae (MIC: 1) - Favorable (n=5, 4) | 3 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (ME at TOC Analysis Set) | Kleb. pneumoniae (MIC: 2) - Favorable (n= 2, 1) | 0 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (ME at TOC Analysis Set) | Kleb. pneumoniae (MIC: 4) - Favorable (n=0, 0) | 0 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (ME at TOC Analysis Set) | Kleb. pneumoniae (MIC: 8) - Favorable (n=0, 0) | 0 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (ME at TOC Analysis Set) | Kleb. pneumoniae (MIC: 16) - Favorable (n=0, 0) | 0 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (ME at TOC Analysis Set) | Kleb. pneumoniae (MIC: 32) - Favorable (n=0, 0) | 0 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (ME at TOC Analysis Set) | Kleb. pneumoniae (MIC: >32) - Favorable (n=0, 0) | 0 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (ME at TOC Analysis Set) | Proteus mirabilis (MIC:<=0.008)- Favorable (n=0,0) | 0 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (ME at TOC Analysis Set) | Proteus mirabilis (MIC: 0.015)- Favorable (n=1,0) | 0 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (ME at TOC Analysis Set) | Proteus mirabilis (MIC: 0.03)- Favorable (n=9, 2) | 0 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (ME at TOC Analysis Set) | Proteus mirabilis (MIC: 0.06)- Favorable (n=4,5) | 4 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (ME at TOC Analysis Set) | Proteus mirabilis (MIC: 0.12)- Favorable (n=0,0) | 0 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (ME at TOC Analysis Set) | Proteus mirabilis (MIC: 0.25)- Favorable (n=0, 0) | 0 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (ME at TOC Analysis Set) | Proteus mirabilis (MIC: 0.5)- Favorable (n=0,0) | 0 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (ME at TOC Analysis Set) | Proteus mirabilis (MIC: 1)- Favorable (n=0, 0) | 0 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (ME at TOC Analysis Set) | Proteus mirabilis (MIC: 2)- Favorable (n=0, 0) | 0 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (ME at TOC Analysis Set) | Proteus mirabilis (MIC: 4)- Favorable (n=0, 0) | 0 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (ME at TOC Analysis Set) | Proteus mirabilis (MIC: 8)- Favorable (n=0, 0) | 0 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (ME at TOC Analysis Set) | Proteus mirabilis (MIC: 16)- Favorable (n=0, 0) | 0 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (ME at TOC Analysis Set) | Proteus mirabilis (MIC: 32)- Favorable (n=0, 0) | 0 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (ME at TOC Analysis Set) | Proteus mirabilis (MIC: >32)- Favorable (n=0, 0) | 0 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (ME at TOC Analysis Set) | Entero. cloacae (MIC: <=0.008)- Favorable (n= 0,0) | 0 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (ME at TOC Analysis Set) | Entero. cloacae (MIC: 0.015)- Favorable (n= 0,0) | 0 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (ME at TOC Analysis Set) | Entero. cloacae (MIC: 0.03)- Favorable (n= 1,0) | 0 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (ME at TOC Analysis Set) | Entero. cloacae (MIC: 0.06)- Favorable (n= 0, 1) | 1 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (ME at TOC Analysis Set) | Entero. cloacae (MIC: 0.12)- Favorable (n= 1,2) | 2 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (ME at TOC Analysis Set) | Entero. cloacae (MIC: 0.25)- Favorable (n= 0,3) | 0 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (ME at TOC Analysis Set) | Entero. cloacae (MIC: 0.5)- Favorable (n= 1,1) | 1 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (ME at TOC Analysis Set) | Entero. cloacae (MIC: 1)- Favorable (n= 1,4) | 4 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (ME at TOC Analysis Set) | Entero. cloacae (MIC: 2)- Favorable (n= 1,0) | 0 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (ME at TOC Analysis Set) | Entero. cloacae (MIC: 4)- Favorable (n= 2,0) | 0 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (ME at TOC Analysis Set) | Entero. cloacae (MIC: 8)- Favorable (n= 0,0) | 0 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (ME at TOC Analysis Set) | Entero. cloacae (MIC: 16)- Favorable (n= 0,0) | 0 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (ME at TOC Analysis Set) | Entero. cloacae (MIC: 32)- Favorable (n= 0,0) | 0 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (ME at TOC Analysis Set) | Entero. cloacae (MIC: >32)- Favorable (n= 0,0) | 0 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (ME at TOC Analysis Set) | P.aeruginosa (MIC: <=0.008) - Favorable (n=0,0) | 0 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (ME at TOC Analysis Set) | P.aeruginosa (MIC: 0.015) - Favorable (n=0,0) | 0 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (ME at TOC Analysis Set) | P.aeruginosa (MIC: 0.03) - Favorable (n=0,0) | 0 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (ME at TOC Analysis Set) | P.aeruginosa (MIC: 0.06) - Favorable (n=0,0) | 0 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (ME at TOC Analysis Set) | P.aeruginosa (MIC: 0.12) - Favorable (n=0,0) | 0 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (ME at TOC Analysis Set) | P.aeruginosa (MIC: 0.25) - Favorable (n=0,0) | 0 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (ME at TOC Analysis Set) | P.aeruginosa (MIC: 0.5) - Favorable (n=0,0) | 0 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (ME at TOC Analysis Set) | P.aeruginosa (MIC: 1) - Favorable (n=1,4) | 2 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (ME at TOC Analysis Set) | P.aeruginosa (MIC: 2) - Favorable (n=4,4) | 4 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (ME at TOC Analysis Set) | P.aeruginosa (MIC: 4) - Favorable (n=3,4) | 3 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (ME at TOC Analysis Set) | P.aeruginosa (MIC: 8) - Favorable (n=1,1) | 0 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (ME at TOC Analysis Set) | P.aeruginosa (MIC: 16) - Favorable (n=0,0) | 0 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (ME at TOC Analysis Set) | P.aeruginosa (MIC: 32) - Favorable (n=0,0) | 0 Participant |
Secondary
Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (mMITT Analysis Set)
Per pathogen microbiological response at TOC by CAZ-AVI MIC for baseline pathogen in the mMITT analysis set
Time frame: At TOC visit. TOC visit is 21 to 25 days from Randomization
Population: Microbiological modified intent to treat analysis set (mMITT)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (mMITT Analysis Set) | Proteus mirabilis (MIC: 1)- Favorable (n=0, 0) | 0 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (mMITT Analysis Set) | Kleb.pneumoniae (MIC: 0.12) -Favorable(n=11, 10) | 9 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (mMITT Analysis Set) | Proteus mirabilis (MIC: 2)- Favorable (n=0, 0) | 0 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (mMITT Analysis Set) | E. coli (MIC: 0.25) - Favorable (n=28, 25) | 18 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (mMITT Analysis Set) | Proteus mirabilis (MIC: 4)- Favorable (n=0, 0) | 0 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (mMITT Analysis Set) | Kleb. pneumoniae (MIC: 0.25) - Favorable (n=4, 10) | 1 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (mMITT Analysis Set) | Proteus mirabilis (MIC: 8)- Favorable (n=0, 0) | 0 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (mMITT Analysis Set) | E. coli (MIC: 8) - Favorable (n=0, 0) | 0 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (mMITT Analysis Set) | Proteus mirabilis (MIC: 16)- Favorable (n=0, 0) | 0 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (mMITT Analysis Set) | Kleb. pneumoniae (MIC: 0.5) - Favorable (n=8, 16) | 6 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (mMITT Analysis Set) | Proteus mirabilis (MIC: 32)- Favorable (n=0, 0) | 0 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (mMITT Analysis Set) | E. coli (MIC: 0.06) - Favorable (n=123, 139) | 103 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (mMITT Analysis Set) | Proteus mirabilis (MIC: >32)- Favorable (n=0, 0) | 0 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (mMITT Analysis Set) | Kleb. pneumoniae (MIC: 1) - Favorable (n=8, 5) | 6 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (mMITT Analysis Set) | Entero. cloacae (MIC: <=0.008)- Favorable (n= 0,0) | 0 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (mMITT Analysis Set) | E. coli (MIC: 16) - Favorable (n=0, 0) | 0 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (mMITT Analysis Set) | Entero. cloacae (MIC: 0.015)- Favorable (n= 0,0) | 0 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (mMITT Analysis Set) | Kleb. pneumoniae (MIC: 2) - Favorable (n= 2, 4) | 2 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (mMITT Analysis Set) | Entero. cloacae (MIC: 0.03)- Favorable (n= 1,0) | 1 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (mMITT Analysis Set) | E. coli (MIC: 0.5) - Favorable (n=5, 6) | 4 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (mMITT Analysis Set) | Entero. cloacae (MIC: 0.06)- Favorable (n= 0, 1) | 0 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (mMITT Analysis Set) | Kleb. pneumoniae (MIC: 4) - Favorable (n=0, 0) | 0 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (mMITT Analysis Set) | Entero. cloacae (MIC: 0.12)- Favorable (n= 3,2) | 2 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (mMITT Analysis Set) | E. coli (MIC: 32) - Favorable (n=0, 0) | 0 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (mMITT Analysis Set) | Entero. cloacae (MIC: 0.25)- Favorable (n= 1,4) | 0 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (mMITT Analysis Set) | Kleb. pneumoniae (MIC: 8) - Favorable (n=0, 0) | 0 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (mMITT Analysis Set) | Entero. cloacae (MIC: 0.5)- Favorable (n= 1,1) | 0 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (mMITT Analysis Set) | E. coli (MIC: 0.03) - Favorable (n=28, 35) | 24 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (mMITT Analysis Set) | Entero. cloacae (MIC: 1)- Favorable (n= 2,5) | 1 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (mMITT Analysis Set) | Kleb. pneumoniae (MIC: 16) - Favorable (n=0, 0) | 0 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (mMITT Analysis Set) | Entero. cloacae (MIC: 2)- Favorable (n= 1,0) | 1 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (mMITT Analysis Set) | E. coli (MIC: >32) - Favorable (n=0, 0) | 0 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (mMITT Analysis Set) | Entero. cloacae (MIC: 4)- Favorable (n= 2,0) | 1 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (mMITT Analysis Set) | Kleb. pneumoniae (MIC: 32) - Favorable (n=0, 0) | 0 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (mMITT Analysis Set) | Entero. cloacae (MIC: 8)- Favorable (n= 0,0) | 0 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (mMITT Analysis Set) | E. coli (MIC: 1) - Favorable (n=3, 0) | 1 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (mMITT Analysis Set) | Entero. cloacae (MIC: 16)- Favorable (n= 0,0) | 0 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (mMITT Analysis Set) | Kleb. pneumoniae (MIC: >32) - Favorable (n=0, 1) | 0 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (mMITT Analysis Set) | Entero. cloacae (MIC: 32)- Favorable (n= 0,0) | 0 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (mMITT Analysis Set) | Kleb.pneumoniae (MIC: <=0.008)-Favorable(n=0, 0) | 0 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (mMITT Analysis Set) | Entero. cloacae (MIC: >32)- Favorable (n= 0,0) | 0 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (mMITT Analysis Set) | Proteus mirabilis (MIC:<=0.008)- Favorable (n=0,0) | 0 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (mMITT Analysis Set) | P.aeruginosa (MIC: <=0.008) - Favorable (n=0,0) | 0 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (mMITT Analysis Set) | E. coli (MIC: 0.12) - Favorable (n=90, 81) | 67 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (mMITT Analysis Set) | P.aeruginosa (MIC: 0.015) - Favorable (n=0,0) | 0 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (mMITT Analysis Set) | Proteus mirabilis (MIC: 0.015)- Favorable (n=1,1) | 1 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (mMITT Analysis Set) | P.aeruginosa (MIC: 0.03) - Favorable (n=0,0) | 0 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (mMITT Analysis Set) | Kleb. pneumoniae (MIC: 0.015) - Favorable (n=1, 0) | 1 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (mMITT Analysis Set) | P.aeruginosa (MIC: 0.06) - Favorable (n=0,0) | 0 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (mMITT Analysis Set) | Proteus mirabilis (MIC: 0.03)- Favorable (n=10, 5) | 10 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (mMITT Analysis Set) | P.aeruginosa (MIC: 0.12) - Favorable (n=0,0) | 0 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (mMITT Analysis Set) | E. coli (MIC: 2) - Favorable (n=1, 0) | 1 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (mMITT Analysis Set) | P.aeruginosa (MIC: 0.25) - Favorable (n=0,0) | 0 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (mMITT Analysis Set) | Proteus mirabilis (MIC: 0.06)- Favorable (n=6,6) | 5 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (mMITT Analysis Set) | P.aeruginosa (MIC: 0.5) - Favorable (n=0,2) | 0 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (mMITT Analysis Set) | Kleb. pneumoniae (MIC: 0.03) - Favorable (n=1, 2) | 1 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (mMITT Analysis Set) | P.aeruginosa (MIC: 1) - Favorable (n=1,4) | 1 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (mMITT Analysis Set) | Proteus mirabilis (MIC: 0.12)- Favorable (n=0,0) | 0 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (mMITT Analysis Set) | P.aeruginosa (MIC: 2) - Favorable (n=5,5) | 5 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (mMITT Analysis Set) | E. coli (MIC: 0.015) - Favorable (n=8, 7) | 8 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (mMITT Analysis Set) | P.aeruginosa (MIC: 4) - Favorable (n=7,6) | 3 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (mMITT Analysis Set) | Proteus mirabilis (MIC: 0.25)- Favorable (n=0, 0) | 0 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (mMITT Analysis Set) | P.aeruginosa (MIC: 8) - Favorable (n=2,2) | 1 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (mMITT Analysis Set) | Kleb. pneumoniae (MIC: 0.06) - Favorable (n=9, 8) | 7 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (mMITT Analysis Set) | P.aeruginosa (MIC: 16) - Favorable (n=1,1) | 0 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (mMITT Analysis Set) | Proteus mirabilis (MIC: 0.5)- Favorable (n=0,1) | 0 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (mMITT Analysis Set) | P.aeruginosa (MIC: 32) - Favorable (n=0,0) | 0 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (mMITT Analysis Set) | E. coli (MIC: 4) - Favorable (n=0, 0) | 0 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (mMITT Analysis Set) | P.aeruginosa (MIC: >32) - Favorable (n=2,0) | 2 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (mMITT Analysis Set) | E. coli (MIC: <=0.008) - Favorable (n=5, 6) | 3 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (mMITT Analysis Set) | P.aeruginosa (MIC: >32) - Favorable (n=2,0) | 0 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (mMITT Analysis Set) | E. coli (MIC: <=0.008) - Favorable (n=5, 6) | 5 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (mMITT Analysis Set) | E. coli (MIC: 0.015) - Favorable (n=8, 7) | 6 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (mMITT Analysis Set) | E. coli (MIC: 0.03) - Favorable (n=28, 35) | 23 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (mMITT Analysis Set) | E. coli (MIC: 0.06) - Favorable (n=123, 139) | 111 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (mMITT Analysis Set) | E. coli (MIC: 0.12) - Favorable (n=90, 81) | 54 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (mMITT Analysis Set) | E. coli (MIC: 0.25) - Favorable (n=28, 25) | 13 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (mMITT Analysis Set) | E. coli (MIC: 0.5) - Favorable (n=5, 6) | 2 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (mMITT Analysis Set) | E. coli (MIC: 1) - Favorable (n=3, 0) | 0 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (mMITT Analysis Set) | E. coli (MIC: 2) - Favorable (n=1, 0) | 0 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (mMITT Analysis Set) | E. coli (MIC: 4) - Favorable (n=0, 0) | 0 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (mMITT Analysis Set) | E. coli (MIC: 8) - Favorable (n=0, 0) | 0 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (mMITT Analysis Set) | E. coli (MIC: 16) - Favorable (n=0, 0) | 0 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (mMITT Analysis Set) | E. coli (MIC: 32) - Favorable (n=0, 0) | 0 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (mMITT Analysis Set) | E. coli (MIC: >32) - Favorable (n=0, 0) | 0 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (mMITT Analysis Set) | Kleb.pneumoniae (MIC: <=0.008)-Favorable(n=0, 0) | 0 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (mMITT Analysis Set) | Kleb. pneumoniae (MIC: 0.015) - Favorable (n=1, 0) | 0 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (mMITT Analysis Set) | Kleb. pneumoniae (MIC: 0.03) - Favorable (n=1, 2) | 2 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (mMITT Analysis Set) | Kleb. pneumoniae (MIC: 0.06) - Favorable (n=9, 8) | 8 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (mMITT Analysis Set) | Kleb.pneumoniae (MIC: 0.12) -Favorable(n=11, 10) | 7 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (mMITT Analysis Set) | Kleb. pneumoniae (MIC: 0.25) - Favorable (n=4, 10) | 3 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (mMITT Analysis Set) | Kleb. pneumoniae (MIC: 0.5) - Favorable (n=8, 16) | 11 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (mMITT Analysis Set) | Kleb. pneumoniae (MIC: 1) - Favorable (n=8, 5) | 3 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (mMITT Analysis Set) | Kleb. pneumoniae (MIC: 2) - Favorable (n= 2, 4) | 0 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (mMITT Analysis Set) | Kleb. pneumoniae (MIC: 4) - Favorable (n=0, 0) | 0 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (mMITT Analysis Set) | Kleb. pneumoniae (MIC: 8) - Favorable (n=0, 0) | 0 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (mMITT Analysis Set) | Kleb. pneumoniae (MIC: 16) - Favorable (n=0, 0) | 0 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (mMITT Analysis Set) | Kleb. pneumoniae (MIC: 32) - Favorable (n=0, 0) | 0 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (mMITT Analysis Set) | Kleb. pneumoniae (MIC: >32) - Favorable (n=0, 1) | 1 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (mMITT Analysis Set) | Proteus mirabilis (MIC:<=0.008)- Favorable (n=0,0) | 0 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (mMITT Analysis Set) | Proteus mirabilis (MIC: 0.015)- Favorable (n=1,1) | 0 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (mMITT Analysis Set) | Proteus mirabilis (MIC: 0.03)- Favorable (n=10, 5) | 3 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (mMITT Analysis Set) | Proteus mirabilis (MIC: 0.06)- Favorable (n=6,6) | 5 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (mMITT Analysis Set) | Proteus mirabilis (MIC: 0.12)- Favorable (n=0,0) | 0 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (mMITT Analysis Set) | Proteus mirabilis (MIC: 0.25)- Favorable (n=0, 0) | 0 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (mMITT Analysis Set) | Proteus mirabilis (MIC: 0.5)- Favorable (n=0,1) | 1 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (mMITT Analysis Set) | Proteus mirabilis (MIC: 1)- Favorable (n=0, 0) | 0 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (mMITT Analysis Set) | Proteus mirabilis (MIC: 2)- Favorable (n=0, 0) | 0 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (mMITT Analysis Set) | Proteus mirabilis (MIC: 4)- Favorable (n=0, 0) | 0 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (mMITT Analysis Set) | Proteus mirabilis (MIC: 8)- Favorable (n=0, 0) | 0 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (mMITT Analysis Set) | Proteus mirabilis (MIC: 16)- Favorable (n=0, 0) | 0 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (mMITT Analysis Set) | Proteus mirabilis (MIC: 32)- Favorable (n=0, 0) | 0 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (mMITT Analysis Set) | Proteus mirabilis (MIC: >32)- Favorable (n=0, 0) | 0 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (mMITT Analysis Set) | Entero. cloacae (MIC: <=0.008)- Favorable (n= 0,0) | 0 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (mMITT Analysis Set) | Entero. cloacae (MIC: 0.015)- Favorable (n= 0,0) | 0 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (mMITT Analysis Set) | Entero. cloacae (MIC: 0.03)- Favorable (n= 1,0) | 0 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (mMITT Analysis Set) | Entero. cloacae (MIC: 0.06)- Favorable (n= 0, 1) | 1 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (mMITT Analysis Set) | Entero. cloacae (MIC: 0.12)- Favorable (n= 3,2) | 2 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (mMITT Analysis Set) | Entero. cloacae (MIC: 0.25)- Favorable (n= 1,4) | 1 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (mMITT Analysis Set) | Entero. cloacae (MIC: 0.5)- Favorable (n= 1,1) | 1 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (mMITT Analysis Set) | Entero. cloacae (MIC: 1)- Favorable (n= 2,5) | 4 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (mMITT Analysis Set) | Entero. cloacae (MIC: 2)- Favorable (n= 1,0) | 0 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (mMITT Analysis Set) | Entero. cloacae (MIC: 4)- Favorable (n= 2,0) | 0 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (mMITT Analysis Set) | Entero. cloacae (MIC: 8)- Favorable (n= 0,0) | 0 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (mMITT Analysis Set) | Entero. cloacae (MIC: 16)- Favorable (n= 0,0) | 0 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (mMITT Analysis Set) | Entero. cloacae (MIC: 32)- Favorable (n= 0,0) | 0 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (mMITT Analysis Set) | Entero. cloacae (MIC: >32)- Favorable (n= 0,0) | 0 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (mMITT Analysis Set) | P.aeruginosa (MIC: <=0.008) - Favorable (n=0,0) | 0 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (mMITT Analysis Set) | P.aeruginosa (MIC: 0.015) - Favorable (n=0,0) | 0 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (mMITT Analysis Set) | P.aeruginosa (MIC: 0.03) - Favorable (n=0,0) | 0 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (mMITT Analysis Set) | P.aeruginosa (MIC: 0.06) - Favorable (n=0,0) | 0 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (mMITT Analysis Set) | P.aeruginosa (MIC: 0.12) - Favorable (n=0,0) | 0 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (mMITT Analysis Set) | P.aeruginosa (MIC: 0.25) - Favorable (n=0,0) | 0 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (mMITT Analysis Set) | P.aeruginosa (MIC: 0.5) - Favorable (n=0,2) | 2 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (mMITT Analysis Set) | P.aeruginosa (MIC: 1) - Favorable (n=1,4) | 2 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (mMITT Analysis Set) | P.aeruginosa (MIC: 2) - Favorable (n=5,5) | 5 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (mMITT Analysis Set) | P.aeruginosa (MIC: 4) - Favorable (n=7,6) | 4 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (mMITT Analysis Set) | P.aeruginosa (MIC: 8) - Favorable (n=2,2) | 1 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (mMITT Analysis Set) | P.aeruginosa (MIC: 16) - Favorable (n=1,1) | 1 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (mMITT Analysis Set) | P.aeruginosa (MIC: 32) - Favorable (n=0,0) | 0 Participant |
Secondary
Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (Extended ME at TOC Analysis Set)
Per pathogen microbiological response at TOC by Doripenem MIC for baseline pathogen in the Extended ME at TOC analysis set
Time frame: At TOC visit. TOC visit is 21 to 25 days from Randomization
Population: Extended microbiological evaluable analysis set at TOC (EME at TOC)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (Extended ME at TOC Analysis Set) | E. coli (MIC: 0.015) - Favorable (n=122, 119) | 106 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (Extended ME at TOC Analysis Set) | Proteus mirabilis (MIC: 1)- Favorable (n=0, 0) | 0 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (Extended ME at TOC Analysis Set) | Kleb.pneumoniae (MIC: 0.12) -Favorable(n=3, 2) | 2 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (Extended ME at TOC Analysis Set) | Proteus mirabilis (MIC: 2)- Favorable (n=0, 0) | 0 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (Extended ME at TOC Analysis Set) | E. coli (MIC: 4) - Favorable (n=0, 0) | 0 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (Extended ME at TOC Analysis Set) | Proteus mirabilis (MIC: 4)- Favorable (n=0, 0) | 0 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (Extended ME at TOC Analysis Set) | Kleb. pneumoniae (MIC: 0.25) - Favorable (n=2, 2) | 1 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (Extended ME at TOC Analysis Set) | Proteus mirabilis (MIC: 8)- Favorable (n=0, 0) | 0 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (Extended ME at TOC Analysis Set) | E. coli (MIC: 0.25) - Favorable (n=1, 0) | 1 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (Extended ME at TOC Analysis Set) | Proteus mirabilis (MIC: 16)- Favorable (n=0, 0) | 0 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (Extended ME at TOC Analysis Set) | Kleb. pneumoniae (MIC: 0.5) - Favorable (n=1, 0) | 1 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (Extended ME at TOC Analysis Set) | Proteus mirabilis (MIC: >16)- Favorable (n=0, 0) | 0 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (Extended ME at TOC Analysis Set) | E. coli (MIC: 8) - Favorable (n=0, 0) | 0 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (Extended ME at TOC Analysis Set) | Entero. cloacae (MIC: <=0.008)- Favorable (n= 0,0) | 0 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (Extended ME at TOC Analysis Set) | Kleb. pneumoniae (MIC: 1) - Favorable (n=1, 0) | 1 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (Extended ME at TOC Analysis Set) | Entero. cloacae (MIC: 0.015)- Favorable (n= 1,1) | 1 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (Extended ME at TOC Analysis Set) | E. coli (MIC: 0.06) - Favorable (n=10, 8) | 7 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (Extended ME at TOC Analysis Set) | Entero. cloacae (MIC: 0.03)- Favorable (n= 1,4) | 1 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (Extended ME at TOC Analysis Set) | Kleb. pneumoniae (MIC: 2) - Favorable (n= 0,0) | 0 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (Extended ME at TOC Analysis Set) | Entero. cloacae (MIC: 0.06)- Favorable (n= 2, 1) | 1 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (Extended ME at TOC Analysis Set) | E. coli (MIC: 16) - Favorable (n=0, 0) | 0 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (Extended ME at TOC Analysis Set) | Entero. cloacae (MIC: 0.12)- Favorable (n= 0,4) | 0 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (Extended ME at TOC Analysis Set) | Kleb. pneumoniae (MIC: 4) - Favorable (n=0, 0) | 0 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (Extended ME at TOC Analysis Set) | Entero. cloacae (MIC: 0.25)- Favorable (n= 0,0) | 0 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (Extended ME at TOC Analysis Set) | E. coli (MIC: 0.5) - Favorable (n=0, 0) | 0 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (Extended ME at TOC Analysis Set) | Entero. cloacae (MIC: 0.5)- Favorable (n= 3,0) | 2 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (Extended ME at TOC Analysis Set) | Kleb. pneumoniae (MIC: 8) - Favorable (n=0, 1) | 0 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (Extended ME at TOC Analysis Set) | Entero. cloacae (MIC: 1)- Favorable (n= 0,1) | 0 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (Extended ME at TOC Analysis Set) | E. coli (MIC: >16) - Favorable (n=0, 0) | 0 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (Extended ME at TOC Analysis Set) | Entero. cloacae (MIC: 2)- Favorable (n= 0,0) | 0 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (Extended ME at TOC Analysis Set) | Kleb. pneumoniae (MIC: 16) - Favorable (n=0, 0) | 0 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (Extended ME at TOC Analysis Set) | Entero. cloacae (MIC: 4)- Favorable (n= 0,0) | 0 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (Extended ME at TOC Analysis Set) | E. coli (MIC: 0.03) - Favorable (n=79, 89) | 64 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (Extended ME at TOC Analysis Set) | Entero. cloacae (MIC: 8)- Favorable (n= 0,0) | 0 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (Extended ME at TOC Analysis Set) | Kleb. pneumoniae (MIC: >16) - Favorable (n=1, 0) | 1 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (Extended ME at TOC Analysis Set) | Entero. cloacae (MIC: 16)- Favorable (n= 0,0) | 0 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (Extended ME at TOC Analysis Set) | Kleb.pneumoniae (MIC: <=0.008)-Favorable(n=0, 0) | 0 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (Extended ME at TOC Analysis Set) | Entero. cloacae (MIC: >16)- Favorable (n= 0,0) | 0 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (Extended ME at TOC Analysis Set) | Proteus mirabilis (MIC:<=0.008)- Favorable (n=0,0) | 0 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (Extended ME at TOC Analysis Set) | P.aeruginosa (MIC: <=0.008) - Favorable (n=0,0) | 0 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (Extended ME at TOC Analysis Set) | E. coli (MIC: 1) - Favorable (n=0, 0) | 0 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (Extended ME at TOC Analysis Set) | P.aeruginosa (MIC: 0.015) - Favorable (n=0,0) | 0 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (Extended ME at TOC Analysis Set) | Proteus mirabilis (MIC: 0.015)- Favorable (n=0,0) | 0 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (Extended ME at TOC Analysis Set) | P.aeruginosa (MIC: 0.03) - Favorable (n=0,0) | 0 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (Extended ME at TOC Analysis Set) | Kleb. pneumoniae (MIC: 0.015) - Favorable (n=1, 2) | 1 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (Extended ME at TOC Analysis Set) | P.aeruginosa (MIC: 0.06) - Favorable (n=2,3) | 2 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (Extended ME at TOC Analysis Set) | Proteus mirabilis (MIC: 0.03)- Favorable (n=1,0) | 1 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (Extended ME at TOC Analysis Set) | P.aeruginosa (MIC: 0.12) - Favorable (n=1,2) | 0 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (Extended ME at TOC Analysis Set) | E. coli (MIC: 0.12) - Favorable (n=1, 2) | 1 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (Extended ME at TOC Analysis Set) | P.aeruginosa (MIC: 0.25) - Favorable (n=2,4) | 2 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (Extended ME at TOC Analysis Set) | Proteus mirabilis (MIC: 0.06)- Favorable (n=2,2) | 2 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (Extended ME at TOC Analysis Set) | P.aeruginosa (MIC: 0.5) - Favorable (n=2,1) | 2 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (Extended ME at TOC Analysis Set) | Kleb. pneumoniae (MIC:0.03) - Favorable (n=15, 23) | 12 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (Extended ME at TOC Analysis Set) | P.aeruginosa (MIC: 1) - Favorable (n=1,3) | 0 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (Extended ME at TOC Analysis Set) | Proteus mirabilis (MIC: 0.12)- Favorable (n=4,2) | 4 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (Extended ME at TOC Analysis Set) | P.aeruginosa (MIC: 2) - Favorable (n=1,0) | 1 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (Extended ME at TOC Analysis Set) | E. coli (MIC: 2) - Favorable (n=0, 0) | 0 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (Extended ME at TOC Analysis Set) | P.aeruginosa (MIC: 4) - Favorable (n=0,2) | 0 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (Extended ME at TOC Analysis Set) | Proteus mirabilis (MIC: 0.25)- Favorable (n=6, 3) | 6 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (Extended ME at TOC Analysis Set) | P.aeruginosa (MIC: 8) - Favorable (n=1,1) | 0 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (Extended ME at TOC Analysis Set) | Kleb. pneumoniae (MIC: 0.06) - Favorable (n=8, 12) | 7 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (Extended ME at TOC Analysis Set) | P.aeruginosa (MIC: 16) - Favorable (n=2,1) | 0 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (Extended ME at TOC Analysis Set) | Proteus mirabilis (MIC: 0.5)- Favorable (n=1,0) | 1 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (Extended ME at TOC Analysis Set) | P.aeruginosa (MIC: >16) - Favorable (n=1,1) | 1 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (Extended ME at TOC Analysis Set) | E. coli (MIC: <=0.008) - Favorable (n=1,1) | 1 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (Extended ME at TOC Analysis Set) | P.aeruginosa (MIC: >16) - Favorable (n=1,1) | 1 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (Extended ME at TOC Analysis Set) | E. coli (MIC: <=0.008) - Favorable (n=1,1) | 1 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (Extended ME at TOC Analysis Set) | E. coli (MIC: 0.015) - Favorable (n=122, 119) | 95 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (Extended ME at TOC Analysis Set) | E. coli (MIC: 0.03) - Favorable (n=79, 89) | 70 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (Extended ME at TOC Analysis Set) | E. coli (MIC: 0.06) - Favorable (n=10, 8) | 3 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (Extended ME at TOC Analysis Set) | E. coli (MIC: 0.12) - Favorable (n=1, 2) | 1 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (Extended ME at TOC Analysis Set) | E. coli (MIC: 0.25) - Favorable (n=1, 0) | 0 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (Extended ME at TOC Analysis Set) | E. coli (MIC: 0.5) - Favorable (n=0, 0) | 0 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (Extended ME at TOC Analysis Set) | E. coli (MIC: 1) - Favorable (n=0, 0) | 0 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (Extended ME at TOC Analysis Set) | E. coli (MIC: 2) - Favorable (n=0, 0) | 0 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (Extended ME at TOC Analysis Set) | E. coli (MIC: 4) - Favorable (n=0, 0) | 0 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (Extended ME at TOC Analysis Set) | E. coli (MIC: 8) - Favorable (n=0, 0) | 0 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (Extended ME at TOC Analysis Set) | E. coli (MIC: 16) - Favorable (n=0, 0) | 0 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (Extended ME at TOC Analysis Set) | E. coli (MIC: >16) - Favorable (n=0, 0) | 0 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (Extended ME at TOC Analysis Set) | Kleb.pneumoniae (MIC: <=0.008)-Favorable(n=0, 0) | 0 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (Extended ME at TOC Analysis Set) | Kleb. pneumoniae (MIC: 0.015) - Favorable (n=1, 2) | 1 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (Extended ME at TOC Analysis Set) | Kleb. pneumoniae (MIC:0.03) - Favorable (n=15, 23) | 18 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (Extended ME at TOC Analysis Set) | Kleb. pneumoniae (MIC: 0.06) - Favorable (n=8, 12) | 6 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (Extended ME at TOC Analysis Set) | Kleb.pneumoniae (MIC: 0.12) -Favorable(n=3, 2) | 2 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (Extended ME at TOC Analysis Set) | Kleb. pneumoniae (MIC: 0.25) - Favorable (n=2, 2) | 1 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (Extended ME at TOC Analysis Set) | Kleb. pneumoniae (MIC: 0.5) - Favorable (n=1, 0) | 0 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (Extended ME at TOC Analysis Set) | Kleb. pneumoniae (MIC: 1) - Favorable (n=1, 0) | 0 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (Extended ME at TOC Analysis Set) | Kleb. pneumoniae (MIC: 2) - Favorable (n= 0,0) | 0 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (Extended ME at TOC Analysis Set) | Kleb. pneumoniae (MIC: 4) - Favorable (n=0, 0) | 0 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (Extended ME at TOC Analysis Set) | Kleb. pneumoniae (MIC: 8) - Favorable (n=0, 1) | 1 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (Extended ME at TOC Analysis Set) | Kleb. pneumoniae (MIC: 16) - Favorable (n=0, 0) | 0 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (Extended ME at TOC Analysis Set) | Kleb. pneumoniae (MIC: >16) - Favorable (n=1, 0) | 0 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (Extended ME at TOC Analysis Set) | Proteus mirabilis (MIC:<=0.008)- Favorable (n=0,0) | 0 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (Extended ME at TOC Analysis Set) | Proteus mirabilis (MIC: 0.015)- Favorable (n=0,0) | 0 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (Extended ME at TOC Analysis Set) | Proteus mirabilis (MIC: 0.03)- Favorable (n=1,0) | 0 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (Extended ME at TOC Analysis Set) | Proteus mirabilis (MIC: 0.06)- Favorable (n=2,2) | 1 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (Extended ME at TOC Analysis Set) | Proteus mirabilis (MIC: 0.12)- Favorable (n=4,2) | 2 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (Extended ME at TOC Analysis Set) | Proteus mirabilis (MIC: 0.25)- Favorable (n=6, 3) | 1 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (Extended ME at TOC Analysis Set) | Proteus mirabilis (MIC: 0.5)- Favorable (n=1,0) | 0 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (Extended ME at TOC Analysis Set) | Proteus mirabilis (MIC: 1)- Favorable (n=0, 0) | 0 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (Extended ME at TOC Analysis Set) | Proteus mirabilis (MIC: 2)- Favorable (n=0, 0) | 0 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (Extended ME at TOC Analysis Set) | Proteus mirabilis (MIC: 4)- Favorable (n=0, 0) | 0 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (Extended ME at TOC Analysis Set) | Proteus mirabilis (MIC: 8)- Favorable (n=0, 0) | 0 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (Extended ME at TOC Analysis Set) | Proteus mirabilis (MIC: 16)- Favorable (n=0, 0) | 0 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (Extended ME at TOC Analysis Set) | Proteus mirabilis (MIC: >16)- Favorable (n=0, 0) | 0 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (Extended ME at TOC Analysis Set) | Entero. cloacae (MIC: <=0.008)- Favorable (n= 0,0) | 0 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (Extended ME at TOC Analysis Set) | Entero. cloacae (MIC: 0.015)- Favorable (n= 1,1) | 1 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (Extended ME at TOC Analysis Set) | Entero. cloacae (MIC: 0.03)- Favorable (n= 1,4) | 1 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (Extended ME at TOC Analysis Set) | Entero. cloacae (MIC: 0.06)- Favorable (n= 2, 1) | 1 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (Extended ME at TOC Analysis Set) | Entero. cloacae (MIC: 0.12)- Favorable (n= 0,4) | 4 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (Extended ME at TOC Analysis Set) | Entero. cloacae (MIC: 0.25)- Favorable (n= 0,0) | 0 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (Extended ME at TOC Analysis Set) | Entero. cloacae (MIC: 0.5)- Favorable (n= 3,0) | 0 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (Extended ME at TOC Analysis Set) | Entero. cloacae (MIC: 1)- Favorable (n= 0,1) | 1 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (Extended ME at TOC Analysis Set) | Entero. cloacae (MIC: 2)- Favorable (n= 0,0) | 0 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (Extended ME at TOC Analysis Set) | Entero. cloacae (MIC: 4)- Favorable (n= 0,0) | 0 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (Extended ME at TOC Analysis Set) | Entero. cloacae (MIC: 8)- Favorable (n= 0,0) | 0 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (Extended ME at TOC Analysis Set) | Entero. cloacae (MIC: 16)- Favorable (n= 0,0) | 0 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (Extended ME at TOC Analysis Set) | Entero. cloacae (MIC: >16)- Favorable (n= 0,0) | 0 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (Extended ME at TOC Analysis Set) | P.aeruginosa (MIC: <=0.008) - Favorable (n=0,0) | 0 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (Extended ME at TOC Analysis Set) | P.aeruginosa (MIC: 0.015) - Favorable (n=0,0) | 0 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (Extended ME at TOC Analysis Set) | P.aeruginosa (MIC: 0.03) - Favorable (n=0,0) | 0 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (Extended ME at TOC Analysis Set) | P.aeruginosa (MIC: 0.06) - Favorable (n=2,3) | 3 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (Extended ME at TOC Analysis Set) | P.aeruginosa (MIC: 0.12) - Favorable (n=1,2) | 2 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (Extended ME at TOC Analysis Set) | P.aeruginosa (MIC: 0.25) - Favorable (n=2,4) | 1 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (Extended ME at TOC Analysis Set) | P.aeruginosa (MIC: 0.5) - Favorable (n=2,1) | 1 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (Extended ME at TOC Analysis Set) | P.aeruginosa (MIC: 1) - Favorable (n=1,3) | 2 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (Extended ME at TOC Analysis Set) | P.aeruginosa (MIC: 2) - Favorable (n=1,0) | 0 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (Extended ME at TOC Analysis Set) | P.aeruginosa (MIC: 4) - Favorable (n=0,2) | 1 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (Extended ME at TOC Analysis Set) | P.aeruginosa (MIC: 8) - Favorable (n=1,1) | 1 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (Extended ME at TOC Analysis Set) | P.aeruginosa (MIC: 16) - Favorable (n=2,1) | 1 Participant |
Secondary
Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (ME at TOC Analysis Set)
Per pathogen microbiological response at TOC by Doripenem MIC for baseline pathogen in the ME at TOC analysis set
Time frame: At TOC visit. TOC visit is 21 to 25 days from Randomization
Population: Microbiological evaluable analysis set at TOC (ME at TOC)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (ME at TOC Analysis Set) | Kleb. pneumoniae (MIC:0.03) - Favorable (n=15, 23) | 12 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (ME at TOC Analysis Set) | Proteus mirabilis (MIC: 0.5)- Favorable (n=1,0) | 1 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (ME at TOC Analysis Set) | E. coli (MIC: 1) - Favorable (n=0, 0) | 0 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (ME at TOC Analysis Set) | Proteus mirabilis (MIC: 1)- Favorable (n=0, 0) | 0 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (ME at TOC Analysis Set) | Kleb. pneumoniae (MIC: 0.06) - Favorable (n=8, 12) | 7 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (ME at TOC Analysis Set) | Proteus mirabilis (MIC: 2)- Favorable (n=0, 0) | 0 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (ME at TOC Analysis Set) | E. coli (MIC: 0.06) - Favorable (n=10, 8) | 7 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (ME at TOC Analysis Set) | Proteus mirabilis (MIC: 4)- Favorable (n=0, 0) | 0 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (ME at TOC Analysis Set) | Kleb.pneumoniae (MIC: 0.12) -Favorable(n=3,2) | 2 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (ME at TOC Analysis Set) | Proteus mirabilis (MIC: 8)- Favorable (n=0, 0) | 0 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (ME at TOC Analysis Set) | E. coli (MIC: 2) - Favorable (n=0, 0) | 0 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (ME at TOC Analysis Set) | Proteus mirabilis (MIC: 16)- Favorable (n=0, 0) | 0 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (ME at TOC Analysis Set) | Kleb. pneumoniae (MIC: 0.25) - Favorable (n=2, 2) | 1 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (ME at TOC Analysis Set) | Proteus mirabilis (MIC: >16)- Favorable (n=0, 0) | 0 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (ME at TOC Analysis Set) | E. coli (MIC: 0.015) - Favorable (n=122, 119) | 106 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (ME at TOC Analysis Set) | Entero. cloacae (MIC: <=0.008)- Favorable (n= 0,0) | 0 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (ME at TOC Analysis Set) | Kleb. pneumoniae (MIC: 0.5) - Favorable (n=1,0) | 1 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (ME at TOC Analysis Set) | Entero. cloacae (MIC: 0.015)- Favorable (n= 1,1) | 1 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (ME at TOC Analysis Set) | E. coli (MIC: 4) - Favorable (n=0, 0) | 0 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (ME at TOC Analysis Set) | Entero. cloacae (MIC: 0.03)- Favorable (n= 1,4) | 1 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (ME at TOC Analysis Set) | Kleb. pneumoniae (MIC: 1) - Favorable (n=1, 0) | 1 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (ME at TOC Analysis Set) | Entero. cloacae (MIC: 0.06)- Favorable (n= 2, 1) | 1 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (ME at TOC Analysis Set) | E. coli (MIC: 0.12) - Favorable (n=1,2) | 1 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (ME at TOC Analysis Set) | Entero. cloacae (MIC: 0.12)- Favorable (n= 0,4) | 0 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (ME at TOC Analysis Set) | Kleb. pneumoniae (MIC: 2) - Favorable (n= 0,0) | 0 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (ME at TOC Analysis Set) | Entero. cloacae (MIC: 0.25)- Favorable (n= 0,0) | 0 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (ME at TOC Analysis Set) | E. coli (MIC: 8) - Favorable (n=0, 0) | 0 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (ME at TOC Analysis Set) | Entero. cloacae (MIC: 0.5)- Favorable (n= 3,0) | 2 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (ME at TOC Analysis Set) | Kleb. pneumoniae (MIC: 4) - Favorable (n=0, 0) | 0 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (ME at TOC Analysis Set) | Entero. cloacae (MIC: 1)- Favorable (n= 0,1) | 0 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (ME at TOC Analysis Set) | E. coli (MIC: <=0.008) - Favorable (n=1,1) | 1 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (ME at TOC Analysis Set) | Entero. cloacae (MIC: 2)- Favorable (n= 0,0) | 0 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (ME at TOC Analysis Set) | Kleb. pneumoniae (MIC: 8) - Favorable (n=0, 0) | 0 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (ME at TOC Analysis Set) | Entero. cloacae (MIC: 4)- Favorable (n= 0,0) | 0 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (ME at TOC Analysis Set) | E. coli (MIC: 16) - Favorable (n=0, 0) | 0 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (ME at TOC Analysis Set) | Entero. cloacae (MIC: 8)- Favorable (n= 0,0) | 0 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (ME at TOC Analysis Set) | Kleb. pneumoniae (MIC: 16) - Favorable (n=0, 0) | 0 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (ME at TOC Analysis Set) | Entero. cloacae (MIC: 16)- Favorable (n= 0,0) | 0 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (ME at TOC Analysis Set) | E. coli (MIC: 0.25) - Favorable (n=1,0) | 1 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (ME at TOC Analysis Set) | Entero. cloacae (MIC: >16)- Favorable (n= 0,0) | 0 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (ME at TOC Analysis Set) | Kleb. pneumoniae (MIC: >16) - Favorable (n=0, 0) | 0 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (ME at TOC Analysis Set) | P.aeruginosa (MIC: <=0.008) - Favorable (n=0,0) | 0 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (ME at TOC Analysis Set) | E. coli (MIC: >16) - Favorable (n=0, 0) | 0 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (ME at TOC Analysis Set) | P.aeruginosa (MIC: 0.015) - Favorable (n=0,0) | 0 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (ME at TOC Analysis Set) | Proteus mirabilis (MIC:<=0.008)- Favorable (n=0,0) | 0 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (ME at TOC Analysis Set) | P.aeruginosa (MIC: 0.03) - Favorable (n=0,0) | 0 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (ME at TOC Analysis Set) | E. coli (MIC: 0.03) - Favorable (n=79, 89) | 64 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (ME at TOC Analysis Set) | P.aeruginosa (MIC: 0.06) - Favorable (n=2,3) | 2 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (ME at TOC Analysis Set) | Proteus mirabilis (MIC: 0.015)- Favorable (n=0,0) | 0 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (ME at TOC Analysis Set) | P.aeruginosa (MIC: 0.12) - Favorable (n=1,2) | 0 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (ME at TOC Analysis Set) | Kleb.pneumoniae (MIC: <=0.008)-Favorable(n=0, 0) | 0 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (ME at TOC Analysis Set) | P.aeruginosa (MIC: 0.25) - Favorable (n=2,4) | 2 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (ME at TOC Analysis Set) | Proteus mirabilis (MIC: 0.03)- Favorable (n=1, 0) | 1 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (ME at TOC Analysis Set) | P.aeruginosa (MIC: 0.5) - Favorable (n=2,1) | 2 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (ME at TOC Analysis Set) | E. coli (MIC: 0.5) - Favorable (n=0,0) | 0 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (ME at TOC Analysis Set) | P.aeruginosa (MIC: 1) - Favorable (n=1,3) | 0 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (ME at TOC Analysis Set) | Proteus mirabilis (MIC: 0.06)- Favorable (n=2,2) | 2 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (ME at TOC Analysis Set) | P.aeruginosa (MIC: 2) - Favorable (n=1,0) | 1 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (ME at TOC Analysis Set) | Kleb. pneumoniae (MIC: 0.015) - Favorable (n=1, 2) | 1 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (ME at TOC Analysis Set) | P.aeruginosa (MIC: 4) - Favorable (n=0,0) | 0 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (ME at TOC Analysis Set) | Proteus mirabilis (MIC: 0.12)- Favorable (n=4,2) | 4 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (ME at TOC Analysis Set) | P.aeruginosa (MIC: 8) - Favorable (n=0,0) | 0 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (ME at TOC Analysis Set) | P.aeruginosa (MIC: >16) - Favorable (n=0,0) | 0 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (ME at TOC Analysis Set) | P.aeruginosa (MIC: 16) - Favorable (n=0,0) | 0 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (ME at TOC Analysis Set) | Proteus mirabilis (MIC: 0.25)- Favorable (n=6, 3) | 6 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (ME at TOC Analysis Set) | P.aeruginosa (MIC: >16) - Favorable (n=0,0) | 0 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (ME at TOC Analysis Set) | E. coli (MIC: <=0.008) - Favorable (n=1,1) | 1 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (ME at TOC Analysis Set) | E. coli (MIC: 0.015) - Favorable (n=122, 119) | 95 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (ME at TOC Analysis Set) | E. coli (MIC: 0.03) - Favorable (n=79, 89) | 70 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (ME at TOC Analysis Set) | E. coli (MIC: 0.06) - Favorable (n=10, 8) | 3 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (ME at TOC Analysis Set) | E. coli (MIC: 0.12) - Favorable (n=1,2) | 1 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (ME at TOC Analysis Set) | E. coli (MIC: 0.25) - Favorable (n=1,0) | 0 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (ME at TOC Analysis Set) | E. coli (MIC: 0.5) - Favorable (n=0,0) | 0 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (ME at TOC Analysis Set) | E. coli (MIC: 1) - Favorable (n=0, 0) | 0 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (ME at TOC Analysis Set) | E. coli (MIC: 2) - Favorable (n=0, 0) | 0 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (ME at TOC Analysis Set) | E. coli (MIC: 4) - Favorable (n=0, 0) | 0 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (ME at TOC Analysis Set) | E. coli (MIC: 8) - Favorable (n=0, 0) | 0 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (ME at TOC Analysis Set) | E. coli (MIC: 16) - Favorable (n=0, 0) | 0 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (ME at TOC Analysis Set) | E. coli (MIC: >16) - Favorable (n=0, 0) | 0 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (ME at TOC Analysis Set) | Kleb.pneumoniae (MIC: <=0.008)-Favorable(n=0, 0) | 0 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (ME at TOC Analysis Set) | Kleb. pneumoniae (MIC: 0.015) - Favorable (n=1, 2) | 1 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (ME at TOC Analysis Set) | Kleb. pneumoniae (MIC:0.03) - Favorable (n=15, 23) | 18 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (ME at TOC Analysis Set) | Kleb. pneumoniae (MIC: 0.06) - Favorable (n=8, 12) | 6 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (ME at TOC Analysis Set) | Kleb.pneumoniae (MIC: 0.12) -Favorable(n=3,2) | 2 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (ME at TOC Analysis Set) | Kleb. pneumoniae (MIC: 0.25) - Favorable (n=2, 2) | 1 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (ME at TOC Analysis Set) | Kleb. pneumoniae (MIC: 0.5) - Favorable (n=1,0) | 0 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (ME at TOC Analysis Set) | Kleb. pneumoniae (MIC: 1) - Favorable (n=1, 0) | 0 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (ME at TOC Analysis Set) | Kleb. pneumoniae (MIC: 2) - Favorable (n= 0,0) | 0 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (ME at TOC Analysis Set) | Kleb. pneumoniae (MIC: 4) - Favorable (n=0, 0) | 0 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (ME at TOC Analysis Set) | Kleb. pneumoniae (MIC: 8) - Favorable (n=0, 0) | 0 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (ME at TOC Analysis Set) | Kleb. pneumoniae (MIC: 16) - Favorable (n=0, 0) | 0 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (ME at TOC Analysis Set) | Kleb. pneumoniae (MIC: >16) - Favorable (n=0, 0) | 0 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (ME at TOC Analysis Set) | Proteus mirabilis (MIC:<=0.008)- Favorable (n=0,0) | 0 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (ME at TOC Analysis Set) | Proteus mirabilis (MIC: 0.015)- Favorable (n=0,0) | 0 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (ME at TOC Analysis Set) | Proteus mirabilis (MIC: 0.03)- Favorable (n=1, 0) | 0 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (ME at TOC Analysis Set) | Proteus mirabilis (MIC: 0.06)- Favorable (n=2,2) | 1 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (ME at TOC Analysis Set) | Proteus mirabilis (MIC: 0.12)- Favorable (n=4,2) | 2 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (ME at TOC Analysis Set) | Proteus mirabilis (MIC: 0.25)- Favorable (n=6, 3) | 1 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (ME at TOC Analysis Set) | Proteus mirabilis (MIC: 0.5)- Favorable (n=1,0) | 0 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (ME at TOC Analysis Set) | Proteus mirabilis (MIC: 1)- Favorable (n=0, 0) | 0 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (ME at TOC Analysis Set) | Proteus mirabilis (MIC: 2)- Favorable (n=0, 0) | 0 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (ME at TOC Analysis Set) | Proteus mirabilis (MIC: 4)- Favorable (n=0, 0) | 0 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (ME at TOC Analysis Set) | Proteus mirabilis (MIC: 8)- Favorable (n=0, 0) | 0 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (ME at TOC Analysis Set) | Proteus mirabilis (MIC: 16)- Favorable (n=0, 0) | 0 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (ME at TOC Analysis Set) | Proteus mirabilis (MIC: >16)- Favorable (n=0, 0) | 0 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (ME at TOC Analysis Set) | Entero. cloacae (MIC: <=0.008)- Favorable (n= 0,0) | 0 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (ME at TOC Analysis Set) | Entero. cloacae (MIC: 0.015)- Favorable (n= 1,1) | 1 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (ME at TOC Analysis Set) | Entero. cloacae (MIC: 0.03)- Favorable (n= 1,4) | 1 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (ME at TOC Analysis Set) | Entero. cloacae (MIC: 0.06)- Favorable (n= 2, 1) | 1 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (ME at TOC Analysis Set) | Entero. cloacae (MIC: 0.12)- Favorable (n= 0,4) | 4 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (ME at TOC Analysis Set) | Entero. cloacae (MIC: 0.25)- Favorable (n= 0,0) | 0 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (ME at TOC Analysis Set) | Entero. cloacae (MIC: 0.5)- Favorable (n= 3,0) | 0 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (ME at TOC Analysis Set) | Entero. cloacae (MIC: 1)- Favorable (n= 0,1) | 1 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (ME at TOC Analysis Set) | Entero. cloacae (MIC: 2)- Favorable (n= 0,0) | 0 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (ME at TOC Analysis Set) | Entero. cloacae (MIC: 4)- Favorable (n= 0,0) | 0 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (ME at TOC Analysis Set) | Entero. cloacae (MIC: 8)- Favorable (n= 0,0) | 0 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (ME at TOC Analysis Set) | Entero. cloacae (MIC: 16)- Favorable (n= 0,0) | 0 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (ME at TOC Analysis Set) | Entero. cloacae (MIC: >16)- Favorable (n= 0,0) | 0 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (ME at TOC Analysis Set) | P.aeruginosa (MIC: <=0.008) - Favorable (n=0,0) | 0 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (ME at TOC Analysis Set) | P.aeruginosa (MIC: 0.015) - Favorable (n=0,0) | 0 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (ME at TOC Analysis Set) | P.aeruginosa (MIC: 0.03) - Favorable (n=0,0) | 0 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (ME at TOC Analysis Set) | P.aeruginosa (MIC: 0.06) - Favorable (n=2,3) | 3 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (ME at TOC Analysis Set) | P.aeruginosa (MIC: 0.12) - Favorable (n=1,2) | 2 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (ME at TOC Analysis Set) | P.aeruginosa (MIC: 0.25) - Favorable (n=2,4) | 1 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (ME at TOC Analysis Set) | P.aeruginosa (MIC: 0.5) - Favorable (n=2,1) | 1 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (ME at TOC Analysis Set) | P.aeruginosa (MIC: 1) - Favorable (n=1,3) | 2 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (ME at TOC Analysis Set) | P.aeruginosa (MIC: 2) - Favorable (n=1,0) | 0 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (ME at TOC Analysis Set) | P.aeruginosa (MIC: 4) - Favorable (n=0,0) | 0 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (ME at TOC Analysis Set) | P.aeruginosa (MIC: 8) - Favorable (n=0,0) | 0 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (ME at TOC Analysis Set) | P.aeruginosa (MIC: 16) - Favorable (n=0,0) | 0 Participant |
Secondary
Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (mMITT Analysis Set)
Per pathogen microbiological response at TOC by Doripenem MIC for baseline pathogen in the mMITT analysis set
Time frame: At TOC visit. TOC visit is 21 to 25 days from Randomization
Population: Microbiological modified intent to treat analysis set (mMITT)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (mMITT Analysis Set) | E. coli (MIC: 0.015) - Favorable (n=160, 160) | 127 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (mMITT Analysis Set) | Proteus mirabilis (MIC: 1)- Favorable (n=0, 0) | 0 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (mMITT Analysis Set) | Kleb.pneumoniae (MIC: 0.12) -Favorable(n=4,4) | 2 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (mMITT Analysis Set) | Proteus mirabilis (MIC: 2)- Favorable (n=0, 0) | 0 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (mMITT Analysis Set) | E. coli (MIC: 4) - Favorable (n=0, 0) | 0 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (mMITT Analysis Set) | Proteus mirabilis (MIC: 4)- Favorable (n=0, 0) | 0 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (mMITT Analysis Set) | Kleb. pneumoniae (MIC: 0.25) - Favorable (n=2,3) | 1 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (mMITT Analysis Set) | Proteus mirabilis (MIC: 8)- Favorable (n=0, 0) | 0 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (mMITT Analysis Set) | E. coli (MIC: 0.25) - Favorable (n=1, 0) | 1 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (mMITT Analysis Set) | Proteus mirabilis (MIC: 16)- Favorable (n=0, 0) | 0 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (mMITT Analysis Set) | Kleb. pneumoniae (MIC: 0.5) - Favorable (n=2, 1) | 1 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (mMITT Analysis Set) | Proteus mirabilis (MIC: >16)- Favorable (n=0, 0) | 0 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (mMITT Analysis Set) | E. coli (MIC: 8) - Favorable (n=0, 0) | 0 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (mMITT Analysis Set) | Entero. cloacae (MIC: <=0.008)- Favorable (n= 0,0) | 0 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (mMITT Analysis Set) | Kleb. pneumoniae (MIC: 1) - Favorable (n=1, 0) | 1 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (mMITT Analysis Set) | Entero. cloacae (MIC: 0.015)- Favorable (n= 3,1) | 2 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (mMITT Analysis Set) | E. coli (MIC: 0.06) - Favorable (n=14, 10) | 10 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (mMITT Analysis Set) | Entero. cloacae (MIC: 0.03)- Favorable (n= 1,5) | 1 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (mMITT Analysis Set) | Kleb. pneumoniae (MIC: 2) - Favorable (n= 0, 0) | 0 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (mMITT Analysis Set) | Entero. cloacae (MIC: 0.06)- Favorable (n= 3, 1) | 1 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (mMITT Analysis Set) | E. coli (MIC: 16) - Favorable (n=0, 0) | 0 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (mMITT Analysis Set) | Entero. cloacae (MIC: 0.12)- Favorable (n= 0, 4) | 0 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (mMITT Analysis Set) | Kleb. pneumoniae (MIC: 4) - Favorable (n=0, 0) | 0 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (mMITT Analysis Set) | Entero. cloacae (MIC: 0.25)- Favorable (n= 0,1) | 0 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (mMITT Analysis Set) | E. coli (MIC: 0.5) - Favorable (n=0,0) | 0 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (mMITT Analysis Set) | Entero. cloacae (MIC: 0.5)- Favorable (n= 4,0) | 2 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (mMITT Analysis Set) | Kleb. pneumoniae (MIC: 8) - Favorable (n=0, 1) | 0 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (mMITT Analysis Set) | Entero. cloacae (MIC: 1)- Favorable (n= 0,1) | 0 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (mMITT Analysis Set) | E. coli (MIC: >16) - Favorable (n=0, 0) | 0 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (mMITT Analysis Set) | Entero. cloacae (MIC: 2)- Favorable (n= 0,0) | 0 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (mMITT Analysis Set) | Kleb. pneumoniae (MIC: 16) - Favorable (n=0, 1) | 0 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (mMITT Analysis Set) | Entero. cloacae (MIC: 4)- Favorable (n= 0,0) | 0 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (mMITT Analysis Set) | E. coli (MIC: 0.03) - Favorable (n=112, 123) | 89 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (mMITT Analysis Set) | Entero. cloacae (MIC: 8)- Favorable (n= 0,0) | 0 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (mMITT Analysis Set) | Kleb. pneumoniae (MIC: >16) - Favorable (n=1, 0) | 1 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (mMITT Analysis Set) | Entero. cloacae (MIC: 16)- Favorable (n= 0,0) | 0 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (mMITT Analysis Set) | Kleb.pneumoniae (MIC: <=0.008)-Favorable(n=0, 0) | 0 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (mMITT Analysis Set) | Entero. cloacae (MIC: >16)- Favorable (n= 0,0) | 0 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (mMITT Analysis Set) | Proteus mirabilis (MIC:<=0.008)- Favorable (n=0,0) | 0 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (mMITT Analysis Set) | P.aeruginosa (MIC: <=0.008) - Favorable (n=0,0) | 0 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (mMITT Analysis Set) | E. coli (MIC: 1) - Favorable (n=0, 0) | 0 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (mMITT Analysis Set) | P.aeruginosa (MIC: 0.015) - Favorable (n=0,0) | 0 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (mMITT Analysis Set) | Proteus mirabilis (MIC: 0.015)- Favorable (n=0,0) | 0 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (mMITT Analysis Set) | P.aeruginosa (MIC: 0.03) - Favorable (n=0,0) | 0 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (mMITT Analysis Set) | Kleb. pneumoniae (MIC: 0.015) - Favorable (n=1, 3) | 1 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (mMITT Analysis Set) | P.aeruginosa (MIC: 0.06) - Favorable (n=2,3) | 2 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (mMITT Analysis Set) | Proteus mirabilis (MIC: 0.03)- Favorable (n=1, 0) | 1 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (mMITT Analysis Set) | P.aeruginosa (MIC: 0.12) - Favorable (n=2,2) | 1 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (mMITT Analysis Set) | E. coli (MIC: 0.12) - Favorable (n=3, 3) | 1 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (mMITT Analysis Set) | P.aeruginosa (MIC: 0.25) - Favorable (n=2,5) | 2 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (mMITT Analysis Set) | Proteus mirabilis (MIC: 0.06)- Favorable (n=2,2) | 2 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (mMITT Analysis Set) | P.aeruginosa (MIC: 0.5) - Favorable (n=2,1) | 2 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (mMITT Analysis Set) | Kleb. pneumoniae (MIC: 0.03)-Favorable (n=22, 27) | 16 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (mMITT Analysis Set) | P.aeruginosa (MIC: 1) - Favorable (n=1,4) | 0 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (mMITT Analysis Set) | Proteus mirabilis (MIC: 0.12)- Favorable (n=6,5) | 5 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (mMITT Analysis Set) | P.aeruginosa (MIC: 2) - Favorable (n=1,0) | 1 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (mMITT Analysis Set) | E. coli (MIC: 2) - Favorable (n=0, 0) | 0 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (mMITT Analysis Set) | P.aeruginosa (MIC: 4) - Favorable (n=2,2) | 1 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (mMITT Analysis Set) | Proteus mirabilis (MIC: 0.25)- Favorable (n=6, 4) | 6 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (mMITT Analysis Set) | P.aeruginosa (MIC: 8) - Favorable (n=2,1) | 1 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (mMITT Analysis Set) | Kleb. pneumoniae (MIC: 0.06)- Favorable (n=11, 16) | 10 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (mMITT Analysis Set) | P.aeruginosa (MIC: 16) - Favorable (n=2,1) | 0 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (mMITT Analysis Set) | Proteus mirabilis (MIC: 0.5)- Favorable (n=2,2) | 2 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (mMITT Analysis Set) | P.aeruginosa (MIC: >16) - Favorable (n=2,1) | 2 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (mMITT Analysis Set) | E. coli (MIC: <=0.008) - Favorable (n=1, 3) | 1 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (mMITT Analysis Set) | P.aeruginosa (MIC: >16) - Favorable (n=2,1) | 1 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (mMITT Analysis Set) | E. coli (MIC: <=0.008) - Favorable (n=1, 3) | 3 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (mMITT Analysis Set) | E. coli (MIC: 0.015) - Favorable (n=160, 160) | 119 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (mMITT Analysis Set) | E. coli (MIC: 0.03) - Favorable (n=112, 123) | 86 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (mMITT Analysis Set) | E. coli (MIC: 0.06) - Favorable (n=14, 10) | 4 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (mMITT Analysis Set) | E. coli (MIC: 0.12) - Favorable (n=3, 3) | 2 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (mMITT Analysis Set) | E. coli (MIC: 0.25) - Favorable (n=1, 0) | 0 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (mMITT Analysis Set) | E. coli (MIC: 0.5) - Favorable (n=0,0) | 0 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (mMITT Analysis Set) | E. coli (MIC: 1) - Favorable (n=0, 0) | 0 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (mMITT Analysis Set) | E. coli (MIC: 2) - Favorable (n=0, 0) | 0 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (mMITT Analysis Set) | E. coli (MIC: 4) - Favorable (n=0, 0) | 0 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (mMITT Analysis Set) | E. coli (MIC: 8) - Favorable (n=0, 0) | 0 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (mMITT Analysis Set) | E. coli (MIC: 16) - Favorable (n=0, 0) | 0 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (mMITT Analysis Set) | E. coli (MIC: >16) - Favorable (n=0, 0) | 0 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (mMITT Analysis Set) | Kleb.pneumoniae (MIC: <=0.008)-Favorable(n=0, 0) | 0 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (mMITT Analysis Set) | Kleb. pneumoniae (MIC: 0.015) - Favorable (n=1, 3) | 2 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (mMITT Analysis Set) | Kleb. pneumoniae (MIC: 0.03)-Favorable (n=22, 27) | 21 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (mMITT Analysis Set) | Kleb. pneumoniae (MIC: 0.06)- Favorable (n=11, 16) | 7 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (mMITT Analysis Set) | Kleb.pneumoniae (MIC: 0.12) -Favorable(n=4,4) | 2 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (mMITT Analysis Set) | Kleb. pneumoniae (MIC: 0.25) - Favorable (n=2,3) | 2 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (mMITT Analysis Set) | Kleb. pneumoniae (MIC: 0.5) - Favorable (n=2, 1) | 0 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (mMITT Analysis Set) | Kleb. pneumoniae (MIC: 1) - Favorable (n=1, 0) | 0 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (mMITT Analysis Set) | Kleb. pneumoniae (MIC: 2) - Favorable (n= 0, 0) | 0 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (mMITT Analysis Set) | Kleb. pneumoniae (MIC: 4) - Favorable (n=0, 0) | 0 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (mMITT Analysis Set) | Kleb. pneumoniae (MIC: 8) - Favorable (n=0, 1) | 1 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (mMITT Analysis Set) | Kleb. pneumoniae (MIC: 16) - Favorable (n=0, 1) | 0 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (mMITT Analysis Set) | Kleb. pneumoniae (MIC: >16) - Favorable (n=1, 0) | 0 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (mMITT Analysis Set) | Proteus mirabilis (MIC:<=0.008)- Favorable (n=0,0) | 0 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (mMITT Analysis Set) | Proteus mirabilis (MIC: 0.015)- Favorable (n=0,0) | 0 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (mMITT Analysis Set) | Proteus mirabilis (MIC: 0.03)- Favorable (n=1, 0) | 0 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (mMITT Analysis Set) | Proteus mirabilis (MIC: 0.06)- Favorable (n=2,2) | 1 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (mMITT Analysis Set) | Proteus mirabilis (MIC: 0.12)- Favorable (n=6,5) | 4 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (mMITT Analysis Set) | Proteus mirabilis (MIC: 0.25)- Favorable (n=6, 4) | 2 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (mMITT Analysis Set) | Proteus mirabilis (MIC: 0.5)- Favorable (n=2,2) | 2 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (mMITT Analysis Set) | Proteus mirabilis (MIC: 1)- Favorable (n=0, 0) | 0 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (mMITT Analysis Set) | Proteus mirabilis (MIC: 2)- Favorable (n=0, 0) | 0 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (mMITT Analysis Set) | Proteus mirabilis (MIC: 4)- Favorable (n=0, 0) | 0 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (mMITT Analysis Set) | Proteus mirabilis (MIC: 8)- Favorable (n=0, 0) | 0 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (mMITT Analysis Set) | Proteus mirabilis (MIC: 16)- Favorable (n=0, 0) | 0 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (mMITT Analysis Set) | Proteus mirabilis (MIC: >16)- Favorable (n=0, 0) | 0 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (mMITT Analysis Set) | Entero. cloacae (MIC: <=0.008)- Favorable (n= 0,0) | 0 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (mMITT Analysis Set) | Entero. cloacae (MIC: 0.015)- Favorable (n= 3,1) | 1 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (mMITT Analysis Set) | Entero. cloacae (MIC: 0.03)- Favorable (n= 1,5) | 2 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (mMITT Analysis Set) | Entero. cloacae (MIC: 0.06)- Favorable (n= 3, 1) | 1 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (mMITT Analysis Set) | Entero. cloacae (MIC: 0.12)- Favorable (n= 0, 4) | 4 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (mMITT Analysis Set) | Entero. cloacae (MIC: 0.25)- Favorable (n= 0,1) | 0 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (mMITT Analysis Set) | Entero. cloacae (MIC: 0.5)- Favorable (n= 4,0) | 0 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (mMITT Analysis Set) | Entero. cloacae (MIC: 1)- Favorable (n= 0,1) | 1 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (mMITT Analysis Set) | Entero. cloacae (MIC: 2)- Favorable (n= 0,0) | 0 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (mMITT Analysis Set) | Entero. cloacae (MIC: 4)- Favorable (n= 0,0) | 0 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (mMITT Analysis Set) | Entero. cloacae (MIC: 8)- Favorable (n= 0,0) | 0 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (mMITT Analysis Set) | Entero. cloacae (MIC: 16)- Favorable (n= 0,0) | 0 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (mMITT Analysis Set) | Entero. cloacae (MIC: >16)- Favorable (n= 0,0) | 0 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (mMITT Analysis Set) | P.aeruginosa (MIC: <=0.008) - Favorable (n=0,0) | 0 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (mMITT Analysis Set) | P.aeruginosa (MIC: 0.015) - Favorable (n=0,0) | 0 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (mMITT Analysis Set) | P.aeruginosa (MIC: 0.03) - Favorable (n=0,0) | 0 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (mMITT Analysis Set) | P.aeruginosa (MIC: 0.06) - Favorable (n=2,3) | 3 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (mMITT Analysis Set) | P.aeruginosa (MIC: 0.12) - Favorable (n=2,2) | 2 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (mMITT Analysis Set) | P.aeruginosa (MIC: 0.25) - Favorable (n=2,5) | 2 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (mMITT Analysis Set) | P.aeruginosa (MIC: 0.5) - Favorable (n=2,1) | 1 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (mMITT Analysis Set) | P.aeruginosa (MIC: 1) - Favorable (n=1,4) | 3 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (mMITT Analysis Set) | P.aeruginosa (MIC: 2) - Favorable (n=1,0) | 0 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (mMITT Analysis Set) | P.aeruginosa (MIC: 4) - Favorable (n=2,2) | 1 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (mMITT Analysis Set) | P.aeruginosa (MIC: 8) - Favorable (n=2,1) | 1 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (mMITT Analysis Set) | P.aeruginosa (MIC: 16) - Favorable (n=2,1) | 1 Participant |
Secondary
Per-pathogen Microbiological Response at TOC for Baseline Pathogen (Extended ME at TOC Analysis Set)
Number of favorable per-pathogen microbiological responses at the TOC visit in the Extended ME at TOC analysis set
Time frame: At TOC visit. TOC visit is 21 to 25 days from Randomization.
Population: Extended microbiological evaluable analysis set at TOC (EME at TOC)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CAZ-AVI | Per-pathogen Microbiological Response at TOC for Baseline Pathogen (Extended ME at TOC Analysis Set) | Klebsiella pneumoniae - Favorable (n=32, 42) | 26 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC for Baseline Pathogen (Extended ME at TOC Analysis Set) | Enterobacter cloacae - Favorable (n= 7, 11) | 5 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC for Baseline Pathogen (Extended ME at TOC Analysis Set) | Proteus mirabilis - Favorable (n=14, 7) | 14 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC for Baseline Pathogen (Extended ME at TOC Analysis Set) | Pseudomonas aeruginosa - Favorable (n=13, 18) | 8 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC for Baseline Pathogen (Extended ME at TOC Analysis Set) | Escherichia coli - Favorable (n=214, 226) | 180 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC for Baseline Pathogen (Extended ME at TOC Analysis Set) | Pseudomonas aeruginosa - Favorable (n=13, 18) | 13 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC for Baseline Pathogen (Extended ME at TOC Analysis Set) | Escherichia coli - Favorable (n=214, 226) | 176 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC for Baseline Pathogen (Extended ME at TOC Analysis Set) | Klebsiella pneumoniae - Favorable (n=32, 42) | 29 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC for Baseline Pathogen (Extended ME at TOC Analysis Set) | Proteus mirabilis - Favorable (n=14, 7) | 4 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC for Baseline Pathogen (Extended ME at TOC Analysis Set) | Enterobacter cloacae - Favorable (n= 7, 11) | 8 Participant |
Secondary
Per-pathogen Microbiological Response at TOC for Baseline Pathogen (ME at TOC Analysis Set)
Number of favorable per-pathogen microbiological responses at the TOC visit in the ME at TOC analysis set
Time frame: At TOC visit. TOC visit is 21 to 25 days from Randomization.
Population: Microbiological evaluable analysis set at TOC (ME at TOC)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CAZ-AVI | Per-pathogen Microbiological Response at TOC for Baseline Pathogen (ME at TOC Analysis Set) | Klebsiella pneumoniae - Favorable (n=31, 41) | 25 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC for Baseline Pathogen (ME at TOC Analysis Set) | Enterobacter cloacae - Favorable (n= 7, 11) | 5 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC for Baseline Pathogen (ME at TOC Analysis Set) | Proteus mirabilis - Favorable (n=14, 7) | 14 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC for Baseline Pathogen (ME at TOC Analysis Set) | Pseudomonas aeruginosa - Favorable (n=9, 13) | 7 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC for Baseline Pathogen (ME at TOC Analysis Set) | Escherichia coli - Favorable (n=214, 221) | 180 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC for Baseline Pathogen (ME at TOC Analysis Set) | Pseudomonas aeruginosa - Favorable (n=9, 13) | 9 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC for Baseline Pathogen (ME at TOC Analysis Set) | Escherichia coli - Favorable (n=214, 221) | 171 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC for Baseline Pathogen (ME at TOC Analysis Set) | Klebsiella pneumoniae - Favorable (n=31, 41) | 28 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC for Baseline Pathogen (ME at TOC Analysis Set) | Proteus mirabilis - Favorable (n=14, 7) | 4 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC for Baseline Pathogen (ME at TOC Analysis Set) | Enterobacter cloacae - Favorable (n= 7, 11) | 8 Participant |
Secondary
Per-pathogen Microbiological Response at TOC for Baseline Pathogen (mMITT Analysis Set)
Number of favorable per-pathogen microbiological responses at the TOC visit in the mMITT analysis set
Time frame: At TOC visit. TOC visit is 21 to 25 days from Randomization
Population: Microbiological modified intent to treat analysis set (mMITT)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CAZ-AVI | Per-pathogen Microbiological Response at TOC for Baseline Pathogen (mMITT Analysis Set) | Klebsiella pneumoniae - Favorable (n=44, 56) | 33 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC for Baseline Pathogen (mMITT Analysis Set) | Enterobacter cloacae - Favorable (n= 11,13) | 6 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC for Baseline Pathogen (mMITT Analysis Set) | Proteus mirabilis - Favorable (n=17, 13) | 16 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC for Baseline Pathogen (mMITT Analysis Set) | Pseudomonas aeruginosa - Favorable (n=18, 20) | 12 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC for Baseline Pathogen (mMITT Analysis Set) | Escherichia coli - Favorable (n=292, 306) | 229 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC for Baseline Pathogen (mMITT Analysis Set) | Pseudomonas aeruginosa - Favorable (n=18, 20) | 15 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC for Baseline Pathogen (mMITT Analysis Set) | Escherichia coli - Favorable (n=292, 306) | 220 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC for Baseline Pathogen (mMITT Analysis Set) | Klebsiella pneumoniae - Favorable (n=44, 56) | 35 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC for Baseline Pathogen (mMITT Analysis Set) | Proteus mirabilis - Favorable (n=17, 13) | 9 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC for Baseline Pathogen (mMITT Analysis Set) | Enterobacter cloacae - Favorable (n= 11,13) | 9 Participant |
Secondary
Per-pathogen Microbiological Response at TOC for Blood Only (Extended ME at TOC Analysis Set)
Number of favorable per-pathogen microbiological responses at the TOC visit in the Extended ME at TOC analysis set for blood only
Time frame: At TOC visit. TOC visit is 21 to 25 days from Randomization.
Population: Extended microbiological evaluable analysis set at TOC (EME at TOC)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CAZ-AVI | Per-pathogen Microbiological Response at TOC for Blood Only (Extended ME at TOC Analysis Set) | Escherichia coli - Favorable (n=22, 20) | 22 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC for Blood Only (Extended ME at TOC Analysis Set) | Klebsiella pneumoniae - Favorable (n=2, 2) | 2 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC for Blood Only (Extended ME at TOC Analysis Set) | Proteus mirabilis - Favorable (n=1, 0) | 1 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC for Blood Only (Extended ME at TOC Analysis Set) | Pseudomonas aeruginosa - Favorable (n=0, 1) | 0 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC for Blood Only (Extended ME at TOC Analysis Set) | Pseudomonas aeruginosa - Favorable (n=0, 1) | 1 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC for Blood Only (Extended ME at TOC Analysis Set) | Escherichia coli - Favorable (n=22, 20) | 20 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC for Blood Only (Extended ME at TOC Analysis Set) | Proteus mirabilis - Favorable (n=1, 0) | 0 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC for Blood Only (Extended ME at TOC Analysis Set) | Klebsiella pneumoniae - Favorable (n=2, 2) | 2 Participant |
Secondary
Per-pathogen Microbiological Response at TOC for Blood Only (ME at TOC Analysis Set)
Number of favorable per-pathogen microbiological responses at the TOC visit in the ME at TOC analysis set for blood only
Time frame: At TOC visit. TOC visit is 21 to 25 days from Randomization.
Population: Microbiological evaluable analysis set at TOC (ME at TOC)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CAZ-AVI | Per-pathogen Microbiological Response at TOC for Blood Only (ME at TOC Analysis Set) | Escherichia coli - Favorable (n=22, 20) | 22 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC for Blood Only (ME at TOC Analysis Set) | Klebsiella pneumoniae - Favorable (n=2, 2) | 2 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC for Blood Only (ME at TOC Analysis Set) | Proteus mirabilis - Favorable (n=1, 0) | 1 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC for Blood Only (ME at TOC Analysis Set) | Pseudomonas aeruginosa - Favorable (n=0, 1) | 0 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC for Blood Only (ME at TOC Analysis Set) | Pseudomonas aeruginosa - Favorable (n=0, 1) | 1 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC for Blood Only (ME at TOC Analysis Set) | Escherichia coli - Favorable (n=22, 20) | 20 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC for Blood Only (ME at TOC Analysis Set) | Proteus mirabilis - Favorable (n=1, 0) | 0 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC for Blood Only (ME at TOC Analysis Set) | Klebsiella pneumoniae - Favorable (n=2, 2) | 2 Participant |
Secondary
Per-pathogen Microbiological Response at TOC for Blood Only (mMITT Analysis Set)
Number of favorable per-pathogen microbiological responses at the TOC visit in the mMITT analysis set for blood only
Time frame: At TOC visit. TOC visit is 21 to 25 days from Randomization
Population: Microbiological modified intent to treat analysis set (mMITT)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CAZ-AVI | Per-pathogen Microbiological Response at TOC for Blood Only (mMITT Analysis Set) | Escherichia coli - Favorable (n=32, 28) | 31 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC for Blood Only (mMITT Analysis Set) | Klebsiella pneumoniae - Favorable (n=4, 2) | 3 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC for Blood Only (mMITT Analysis Set) | Proteus mirabilis - Favorable (n=1, 0) | 1 Participant |
| CAZ-AVI | Per-pathogen Microbiological Response at TOC for Blood Only (mMITT Analysis Set) | Pseudomonas aeruginosa - Favorable (n=1, 2) | 1 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC for Blood Only (mMITT Analysis Set) | Pseudomonas aeruginosa - Favorable (n=1, 2) | 2 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC for Blood Only (mMITT Analysis Set) | Escherichia coli - Favorable (n=32, 28) | 28 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC for Blood Only (mMITT Analysis Set) | Proteus mirabilis - Favorable (n=1, 0) | 0 Participant |
| Doripenem | Per-pathogen Microbiological Response at TOC for Blood Only (mMITT Analysis Set) | Klebsiella pneumoniae - Favorable (n=4, 2) | 2 Participant |
Secondary
Per-patient Microbiological Response at EOT (IV) (Extended ME at EOT (IV) Analysis Set)
Number of patients with a favorable per-patient microbiological response at EOT (IV)
Time frame: At EOT (IV) visit. EOT (IV) visit is Within 24 hours after completion of the last infusion of IV study therapy and on/before the first dose for oral study therapy
Population: Extended microbiological evaluable analysis set at EOT (IV) (EME at EOT (IV))
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CAZ-AVI | Per-patient Microbiological Response at EOT (IV) (Extended ME at EOT (IV) Analysis Set) | Favorable | 335 Participants |
| CAZ-AVI | Per-patient Microbiological Response at EOT (IV) (Extended ME at EOT (IV) Analysis Set) | Unfavorable | 1 Participants |
| Doripenem | Per-patient Microbiological Response at EOT (IV) (Extended ME at EOT (IV) Analysis Set) | Favorable | 369 Participants |
| Doripenem | Per-patient Microbiological Response at EOT (IV) (Extended ME at EOT (IV) Analysis Set) | Unfavorable | 2 Participants |
Comparison: Confidence interval of the difference (CAZ-AVI treatment group minus Doripenem treatment group) of favorable response rates95% CI: [-1.17, 1.68]Unstratified Miettinen & Nurminen method
Secondary
Per-patient Microbiological Response at EOT (IV) (ME at EOT (IV) Analysis Set)
Number of patients with a favorable per-patient microbiological response at EOT (IV)
Time frame: At EOT (IV) visit. EOT (IV) visit is Within 24 hours after completion of the last infusion of IV study therapy and on/before the first dose for oral study therapy
Population: Microbiological evaluable analysis set at EOT (IV) (ME at EOT (IV))
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CAZ-AVI | Per-patient Microbiological Response at EOT (IV) (ME at EOT (IV) Analysis Set) | Favorable | 324 Participants |
| CAZ-AVI | Per-patient Microbiological Response at EOT (IV) (ME at EOT (IV) Analysis Set) | Unfavorable | 1 Participants |
| Doripenem | Per-patient Microbiological Response at EOT (IV) (ME at EOT (IV) Analysis Set) | Favorable | 359 Participants |
| Doripenem | Per-patient Microbiological Response at EOT (IV) (ME at EOT (IV) Analysis Set) | Unfavorable | 2 Participants |
Comparison: Confidence interval of the difference (CAZ-AVI treatment group minus Doripenem treatment group) of favorable response rates95% CI: [-1.21, 1.72]Unstratified Miettinen & Nurminen method
Secondary
Per-patient Microbiological Response at EOT (IV) (mMITT Analysis Set)
Number of patients with a favorable per-patient microbiological response at EOT (IV)
Time frame: At EOT (IV) visit. EOT (IV) visit is Within 24 hours after completion of the last infusion of IV study therapy and on/before the first dose for oral study therapy
Population: Microbiological modified intent to treat analysis set (mMITT)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CAZ-AVI | Per-patient Microbiological Response at EOT (IV) (mMITT Analysis Set) | Favorable | 374 Participants |
| CAZ-AVI | Per-patient Microbiological Response at EOT (IV) (mMITT Analysis Set) | Unfavorable | 1 Participants |
| CAZ-AVI | Per-patient Microbiological Response at EOT (IV) (mMITT Analysis Set) | Indeterminate | 18 Participants |
| Doripenem | Per-patient Microbiological Response at EOT (IV) (mMITT Analysis Set) | Favorable | 395 Participants |
| Doripenem | Per-patient Microbiological Response at EOT (IV) (mMITT Analysis Set) | Unfavorable | 3 Participants |
| Doripenem | Per-patient Microbiological Response at EOT (IV) (mMITT Analysis Set) | Indeterminate | 19 Participants |
Comparison: Confidence interval of the difference (CAZ-AVI treatment group minus Doripenem treatment group) of favorable response rates95% CI: [-2.7, 3.56]Unstratified Miettinen & Nurminen method
Secondary
Per-patient Microbiological Response at LFU (Extended ME at LFU Analysis Set)
Number of patients with a favorable per patient microbiological response at LFU
Time frame: At LFU visit. LFU visit is 45 to 52 days from Randomization.
Population: Extended microbiological evaluable analysis set at LFU (Extended ME at LFU)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CAZ-AVI | Per-patient Microbiological Response at LFU (Extended ME at LFU Analysis Set) | Favorable | 184 Participants |
| CAZ-AVI | Per-patient Microbiological Response at LFU (Extended ME at LFU Analysis Set) | Unfavorable | 67 Participants |
| Doripenem | Per-patient Microbiological Response at LFU (Extended ME at LFU Analysis Set) | Favorable | 173 Participants |
| Doripenem | Per-patient Microbiological Response at LFU (Extended ME at LFU Analysis Set) | Unfavorable | 99 Participants |
Comparison: Confidence interval of the difference (CAZ-AVI treatment group minus Doripenem treatment group) of favorable response rates95% CI: [1.72, 17.55]Unstratified Miettinen & Nurminen method
Secondary
Per-patient Microbiological Response at LFU (ME at LFU Analysis Set)
Number of patients with a favorable per patient microbiological response at LFU
Time frame: At LFU visit. LFU visit is 45 to 52 days from Randomization.
Population: Microbiological evaluable analysis set at LFU (ME at LFU)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CAZ-AVI | Per-patient Microbiological Response at LFU (ME at LFU Analysis Set) | Favorable | 182 Participants |
| CAZ-AVI | Per-patient Microbiological Response at LFU (ME at LFU Analysis Set) | Unfavorable | 63 Participants |
| Doripenem | Per-patient Microbiological Response at LFU (ME at LFU Analysis Set) | Favorable | 166 Participants |
| Doripenem | Per-patient Microbiological Response at LFU (ME at LFU Analysis Set) | Unfavorable | 96 Participants |
Comparison: Confidence interval of the difference (CAZ-AVI treatment group minus Doripenem treatment group) of favorable response rates95% CI: [2.86, 18.85]Unstratified Miettinen & Nurminen method
Secondary
Per-patient Microbiological Response at LFU (mMITT Analysis Set)
Number of patients with a favorable per patient microbiological response at LFU
Time frame: At LFU visit. LFU visit is 45 to 52 days from Randomization.
Population: Microbiological modified intent to treat analysis set (mMITT)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CAZ-AVI | Per-patient Microbiological Response at LFU (mMITT Analysis Set) | Favorable | 268 Participants |
| CAZ-AVI | Per-patient Microbiological Response at LFU (mMITT Analysis Set) | Unfavorable | 83 Participants |
| CAZ-AVI | Per-patient Microbiological Response at LFU (mMITT Analysis Set) | Indeterminate | 42 Participants |
| Doripenem | Per-patient Microbiological Response at LFU (mMITT Analysis Set) | Favorable | 254 Participants |
| Doripenem | Per-patient Microbiological Response at LFU (mMITT Analysis Set) | Unfavorable | 125 Participants |
| Doripenem | Per-patient Microbiological Response at LFU (mMITT Analysis Set) | Indeterminate | 38 Participants |
Comparison: Confidence interval of the difference (CAZ-AVI treatment group minus Doripenem treatment group) of favorable response rates95% CI: [0.68, 13.81]Unstratified Miettinen & Nurminen method
Secondary
Per-patient Microbiological Response at TOC (Extended ME at TOC Analysis Set)
Number of patients with a favorable per patient microbiological response at TOC
Time frame: At TOC visit. TOC visit is 21 to 25 days from Randomization.
Population: Extended microbiological evaluable analysis set at TOC (Extended ME at TOC)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CAZ-AVI | Per-patient Microbiological Response at TOC (Extended ME at TOC Analysis Set) | Favorable | 243 Participants |
| CAZ-AVI | Per-patient Microbiological Response at TOC (Extended ME at TOC Analysis Set) | Unfavorable | 49 Participants |
| Doripenem | Per-patient Microbiological Response at TOC (Extended ME at TOC Analysis Set) | Favorable | 236 Participants |
| Doripenem | Per-patient Microbiological Response at TOC (Extended ME at TOC Analysis Set) | Unfavorable | 75 Participants |
Comparison: Confidence interval of the difference (CAZ-AVI treatment group minus Doripenem treatment group) of favorable response rates95% CI: [0.88, 13.74]Unstratified Miettinen & Nurminen method
Secondary
Per-patient Microbiological Response at TOC in Patients Infected by Ceftazidime-resistant Gram-negative Pathogen (Extended ME at TOC Analysis Set)
Favorable per-patient microbiological response at the TOC visit for patients infected with a ceftazidime resistant pathogen in the Extended ME at TOC analysis set.
Time frame: At TOC visit. TOC visit is 21 to 25 days from Randomization.
Population: Extended microbiological evaluable analysis set at TOC(Extended ME at TOC)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CAZ-AVI | Per-patient Microbiological Response at TOC in Patients Infected by Ceftazidime-resistant Gram-negative Pathogen (Extended ME at TOC Analysis Set) | Favorable | 37 Participants |
| CAZ-AVI | Per-patient Microbiological Response at TOC in Patients Infected by Ceftazidime-resistant Gram-negative Pathogen (Extended ME at TOC Analysis Set) | Unfavorable | 14 Participants |
| Doripenem | Per-patient Microbiological Response at TOC in Patients Infected by Ceftazidime-resistant Gram-negative Pathogen (Extended ME at TOC Analysis Set) | Favorable | 41 Participants |
| Doripenem | Per-patient Microbiological Response at TOC in Patients Infected by Ceftazidime-resistant Gram-negative Pathogen (Extended ME at TOC Analysis Set) | Unfavorable | 22 Participants |
Comparison: Confidence interval of the difference (CAZ-AVI treatment group minus Doripenem treatment group) of favorable response rates95% CI: [-9.91, 24.01]Unstratified Miettinen & Nurminen method
Secondary
Per-patient Microbiological Response at TOC in Patients Infected by Ceftazidime-resistant Gram-negative Pathogen (ME at TOC Analysis Set)
Favorable per-patient microbiological response at the TOC visit for patients infected with a ceftazidime resistant pathogen in the ME at TOC analysis set.
Time frame: At TOC visit. TOC visit is 21 to 25 days from Randomization.
Population: Microbiological evaluable analysis set at TOC(ME at TOC)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CAZ-AVI | Per-patient Microbiological Response at TOC in Patients Infected by Ceftazidime-resistant Gram-negative Pathogen (ME at TOC Analysis Set) | Favorable | 35 Participants |
| CAZ-AVI | Per-patient Microbiological Response at TOC in Patients Infected by Ceftazidime-resistant Gram-negative Pathogen (ME at TOC Analysis Set) | Unfavorable | 13 Participants |
| Doripenem | Per-patient Microbiological Response at TOC in Patients Infected by Ceftazidime-resistant Gram-negative Pathogen (ME at TOC Analysis Set) | Favorable | 37 Participants |
| Doripenem | Per-patient Microbiological Response at TOC in Patients Infected by Ceftazidime-resistant Gram-negative Pathogen (ME at TOC Analysis Set) | Unfavorable | 20 Participants |
Comparison: Confidence interval of the difference (CAZ-AVI treatment group minus Doripenem treatment group) of favorable response rates95% CI: [-10.03, 25.21]Unstratified Miettinen & Nurminen method
Secondary
Per-patient Microbiological Response at TOC in Patients Infected by Ceftazidime-resistant Gram-negative Pathogen (mMITT Analysis Set)
Favorable per-patient microbiological response at the TOC visit for patients infected with a ceftazidime resistant pathogen in the mMITT analysis set.
Time frame: At TOC visit. TOC visit is 21 to 25 days from Randomization.
Population: Microbiological modified intent to treat analysis set (mMITT)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CAZ-AVI | Per-patient Microbiological Response at TOC in Patients Infected by Ceftazidime-resistant Gram-negative Pathogen (mMITT Analysis Set) | Favorable | 47 Participants |
| CAZ-AVI | Per-patient Microbiological Response at TOC in Patients Infected by Ceftazidime-resistant Gram-negative Pathogen (mMITT Analysis Set) | Unfavorable | 19 Participants |
| CAZ-AVI | Per-patient Microbiological Response at TOC in Patients Infected by Ceftazidime-resistant Gram-negative Pathogen (mMITT Analysis Set) | Indeterminate | 9 Participants |
| Doripenem | Per-patient Microbiological Response at TOC in Patients Infected by Ceftazidime-resistant Gram-negative Pathogen (mMITT Analysis Set) | Favorable | 51 Participants |
| Doripenem | Per-patient Microbiological Response at TOC in Patients Infected by Ceftazidime-resistant Gram-negative Pathogen (mMITT Analysis Set) | Unfavorable | 27 Participants |
| Doripenem | Per-patient Microbiological Response at TOC in Patients Infected by Ceftazidime-resistant Gram-negative Pathogen (mMITT Analysis Set) | Indeterminate | 6 Participants |
Comparison: Confidence interval of the difference (CAZ-AVI treatment group minus Doripenem treatment group) of favorable response rates95% CI: [-13.18, 16.89]Unstratified Miettinen & Nurminen method
Secondary
Per-patient Microbiological Response at TOC (ME at TOC Analysis Set)
Number of patients with a favorable per patient microbiological response at TOC
Time frame: At TOC visit. TOC visit is 21 to 25 days from Randomization.
Population: Microbiological evaluable analysis set at TOC (ME at TOC)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CAZ-AVI | Per-patient Microbiological Response at TOC (ME at TOC Analysis Set) | Favorable | 241 Participants |
| CAZ-AVI | Per-patient Microbiological Response at TOC (ME at TOC Analysis Set) | Unfavorable | 45 Participants |
| Doripenem | Per-patient Microbiological Response at TOC (ME at TOC Analysis Set) | Favorable | 225 Participants |
| Doripenem | Per-patient Microbiological Response at TOC (ME at TOC Analysis Set) | Unfavorable | 73 Participants |
Comparison: Confidence interval of the difference (CAZ-AVI treatment group minus Doripenem treatment group) of favorable response rates95% CI: [2.27, 15.24]Unstratified Miettinen & Nurminen method
Secondary
Plasma Concentrations for Avibactam Between 300 to 360 Minutes After Dose(PK Analysis Set)
Blood samples were taken on Day 3 for ceftazidime (CAZ) and avibactam (AVI) plasma concentration.
Time frame: Between 300 to 360 minutes after dose
Population: PK analysis set (avibactam between 300 to 360 minutes after dose)
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| CAZ-AVI | Plasma Concentrations for Avibactam Between 300 to 360 Minutes After Dose(PK Analysis Set) | 1883.2 NG/ML |
Secondary
Plasma Concentrations for Avibactam Between 30 to 90 Minutes After Dose(PK Analysis Set)
Blood samples were taken on Day 3 for ceftazidime (CAZ) and avibactam (AVI) plasma concentration.
Time frame: Between 30 to 90 minutes after dose
Population: PK analysis set (avibactam between 30 to 90 minutes after dose)
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| CAZ-AVI | Plasma Concentrations for Avibactam Between 30 to 90 Minutes After Dose(PK Analysis Set) | 6587.2 NG/ML |
Secondary
Plasma Concentrations for Avibactam Within 15 Minutes Before/After Dose (PK Analysis Set)
Blood samples were taken on Day 3 for ceftazidime (CAZ) and avibactam (AVI) plasma concentration.
Time frame: within 15 minutes before/after dose
Population: PK analysis set (avibactam within 15 minutes before/after dose)
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| CAZ-AVI | Plasma Concentrations for Avibactam Within 15 Minutes Before/After Dose (PK Analysis Set) | 9307.3 NG/ML |
Secondary
Plasma Concentrations for Ceftazidime Between 300 to 360 Minutes After Dose(PK Analysis Set)
Blood samples were taken on Day 3 for ceftazidime (CAZ) and avibactam (AVI) plasma concentration.
Time frame: Between 300 to 360 minutes after dose
Population: PK analysis set (ceftazidime between 300 to 360 minutes after dose)
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| CAZ-AVI | Plasma Concentrations for Ceftazidime Between 300 to 360 Minutes After Dose(PK Analysis Set) | 16959.6 NG/ML |
Secondary
Plasma Concentrations for Ceftazidime Between 30 to 90 Minutes After Dose(PK Analysis Set)
Blood samples were taken on Day 3 for ceftazidime (CAZ) and avibactam (AVI) plasma concentration.
Time frame: Between 30 to 90 minutes after dose
Population: PK analysis set (ceftazidime between 30 to 90 minutes after dose)
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| CAZ-AVI | Plasma Concentrations for Ceftazidime Between 30 to 90 Minutes After Dose(PK Analysis Set) | 47575.1 NG/ML |
Secondary
Plasma Concentrations for Ceftazidime Within 15 Minutes Before/After Dose (PK Analysis Set)
Blood samples were taken on Day 3 for ceftazidime (CAZ) and avibactam (AVI) plasma concentration.
Time frame: within 15 minutes before/after dose
Population: PK analysis set (ceftazidime within 15 minutes before/after dose)
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| CAZ-AVI | Plasma Concentrations for Ceftazidime Within 15 Minutes Before/After Dose (PK Analysis Set) | 65481.2 NG/ML |
Secondary
Time to First Defervescence While on IV Study Therapy (CE at TOC Analysis Set)
Time to first defervescence while on IV study therapy in patients in the CE at TOC analysis set who have fever at study entry.
Time frame: Time to first defervescence is defined as the time (in days) from the first dose of IV study therapy to first absence of fever, which is temperature ≤ 37.8 C in a 24-hour period.
Population: Clinically evaluable analysis set at TOC(CE at TOC)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CAZ-AVI | Time to First Defervescence While on IV Study Therapy (CE at TOC Analysis Set) | Number of patients with fever (>38°C) at baseline | 123 Participants |
| CAZ-AVI | Time to First Defervescence While on IV Study Therapy (CE at TOC Analysis Set) | Number afebrile at the time of the last obs | 122 Participants |
| CAZ-AVI | Time to First Defervescence While on IV Study Therapy (CE at TOC Analysis Set) | Number censored at the time of the last obs | 1 Participants |
| Doripenem | Time to First Defervescence While on IV Study Therapy (CE at TOC Analysis Set) | Number of patients with fever (>38°C) at baseline | 118 Participants |
| Doripenem | Time to First Defervescence While on IV Study Therapy (CE at TOC Analysis Set) | Number afebrile at the time of the last obs | 113 Participants |
| Doripenem | Time to First Defervescence While on IV Study Therapy (CE at TOC Analysis Set) | Number censored at the time of the last obs | 5 Participants |
Comparison: H0: No difference in time to first defervescence between treatment groups.p-value: 0.155Log Rank
Secondary
Time to First Defervescence While on IV Study Therapy (Extended ME at TOC Analysis Set)
Time to first defervescence while on IV study therapy in patients in the Extended ME at TOC analysis set who have fever at study entry.
Time frame: Time to first defervescence is defined as the time (in days) from the first dose of IV study therapy to first absence of fever, which is temperature ≤ 37.8 C in a 24-hour period.
Population: Extended microbiological evaluable analysis set at TOC(Extended ME at TOC)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CAZ-AVI | Time to First Defervescence While on IV Study Therapy (Extended ME at TOC Analysis Set) | Number of patients with fever (>38°C) at baseline | 124 Participants |
| CAZ-AVI | Time to First Defervescence While on IV Study Therapy (Extended ME at TOC Analysis Set) | Number afebrile at the time of the last obs | 124 Participants |
| CAZ-AVI | Time to First Defervescence While on IV Study Therapy (Extended ME at TOC Analysis Set) | Number censored at the time of the last obs | 0 Participants |
| Doripenem | Time to First Defervescence While on IV Study Therapy (Extended ME at TOC Analysis Set) | Number of patients with fever (>38°C) at baseline | 111 Participants |
| Doripenem | Time to First Defervescence While on IV Study Therapy (Extended ME at TOC Analysis Set) | Number afebrile at the time of the last obs | 108 Participants |
| Doripenem | Time to First Defervescence While on IV Study Therapy (Extended ME at TOC Analysis Set) | Number censored at the time of the last obs | 3 Participants |
Comparison: H0: No difference in time to first defervescence between treatment groups.p-value: 0.08Log Rank
Secondary
Time to First Defervescence While on IV Study Therapy (ME at TOC Analysis Set)
Time to first defervescence while on IV study therapy in patients in the ME at TOC analysis set who have fever at study entry.
Time frame: Time to first defervescence is defined as the time (in days) from the first dose of IV study therapy to first absence of fever, which is temperature ≤ 37.8 C in a 24-hour period.
Population: Microbiological evaluable analysis set at TOC(ME at TOC)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CAZ-AVI | Time to First Defervescence While on IV Study Therapy (ME at TOC Analysis Set) | Number of patients with fever (>38°C) at baseline | 124 Participants |
| CAZ-AVI | Time to First Defervescence While on IV Study Therapy (ME at TOC Analysis Set) | Number afebrile at the time of the last obs | 124 Participants |
| CAZ-AVI | Time to First Defervescence While on IV Study Therapy (ME at TOC Analysis Set) | Number censored at the time of the last obs | 0 Participants |
| Doripenem | Time to First Defervescence While on IV Study Therapy (ME at TOC Analysis Set) | Number of patients with fever (>38°C) at baseline | 108 Participants |
| Doripenem | Time to First Defervescence While on IV Study Therapy (ME at TOC Analysis Set) | Number afebrile at the time of the last obs | 105 Participants |
| Doripenem | Time to First Defervescence While on IV Study Therapy (ME at TOC Analysis Set) | Number censored at the time of the last obs | 3 Participants |
Comparison: H0: No difference in time to first defervescence between treatment groups.p-value: 0.129Log Rank
Secondary
Time to First Defervescence While on IV Study Therapy (mMITT Analysis Set)
Time to first defervescence while on IV study therapy in patients in the mMITT analysis set who have fever at study entry.
Time frame: Time to first defervescence is defined as the time (in days) from the first dose of IV study therapy to first absence of fever, which is temperature ≤ 37.8 C in a 24-hour period.
Population: Microbiological modified intent to treat analysis set (mMITT)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CAZ-AVI | Time to First Defervescence While on IV Study Therapy (mMITT Analysis Set) | Number of patients with fever (>38°C) at baseline | 157 Participants |
| CAZ-AVI | Time to First Defervescence While on IV Study Therapy (mMITT Analysis Set) | Number afebrile at the time of the last obs | 155 Participants |
| CAZ-AVI | Time to First Defervescence While on IV Study Therapy (mMITT Analysis Set) | Number censored at the time of the last obs | 2 Participants |
| Doripenem | Time to First Defervescence While on IV Study Therapy (mMITT Analysis Set) | Number of patients with fever (>38°C) at baseline | 150 Participants |
| Doripenem | Time to First Defervescence While on IV Study Therapy (mMITT Analysis Set) | Number afebrile at the time of the last obs | 143 Participants |
| Doripenem | Time to First Defervescence While on IV Study Therapy (mMITT Analysis Set) | Number censored at the time of the last obs | 7 Participants |
Comparison: H0: No difference in time to first defervescence between treatment groups.p-value: 0.038Log Rank