Complicated Intra-abdominal Infection
Conditions
Keywords
Ceftazidime-avibactam,, Metronidazole,, Meropenem,, Anti-Bacterial Agents,, Anti-Infective Agents,, Therapeutic Uses,, Pharmacologic Actions,, Physiological Effects of Drugs
Brief summary
The purpose of this study is to evaluate the effects of Ceftazidime Avibactam plus Metronidazole compared to Meropenem for treating hospitalized patients with complicated intra-abdominal infections.
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 Plus Metronidazole Versus Meropenem in the Treatment of Complicated Intra-Abdominal Infections In Hospitalized Adults
Interventions
Ceftazidime-Avibactam powder for concentrate for solution for infusion 2000 mg/500 mg
DRUGmetronidazole
Metronidazole 500mg/100ml solution for infusion
DRUGMeropenem
Meropenem powder for solution for infusion 1000mg
Sponsors
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
* Patient must be 18 to 90 years of age, inclusive, * Female patients can participate if they are surgically sterilized or postmenopausal for at least 1 year or her sexual partner has had a vasectomy * Female of childbearing potential has had normal menstrual periods for 3 months and negative serum pregnancy test and agree to practice highly effective methods of birth control during treatment and for at least 7 days after last dose * Intraoperative/postoperative enrollment with visual confirmation (presence of pus within the abdominal cavity) of an intra-abdominal infection associated with peritonitis * Confirmation of infection by surgical intervention within 24 hours of entry: evidence of systemic inflammatory indicators; physical findings consistent with intra-abdominal infection; supportive radiologic imaging findings of intra-abdominal infections
Exclusion criteria
* Patient is diagnosed with traumatic bowel perforation undergoing surgery within 12 hours; perforation of gastroduodenal ulcers undergoing surgery within 24 hours. Other intra-abdominal processes in which primary etiology is not likely to be infectious * Patient has abdominal wall abscess or bowel obstruction without perforation or ischemic bowel without perforation * Patients whose surgery will include staged abdominal repair, or open abdomen technique, or marsupialization * Patient has suspected intra-abdominal infections due to fungus, parasites, virus or tuberculosis * Patient is considered unlikely to survive the 6- to 8-week study period or has a rapidly progressive or terminal illness, including septic shock that is associated with a high risk of mortality
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Proportion of Patients With Clinical Cure at the Test of Cure (TOC) Visit in the Clinically Evaluable (CE) Analysis Set. | At the test of cure visit (Day 28 to35) | The proportion of patients meeting the cure criteria: complete resolution or significant improvement of signs and symptoms of the index infection such that no further antibacterial therapy, drainage, or surgical intervention was necessary. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The Proportion of Patients With Clinical Cure at the Test of Cure (TOC) Visit in the Microbiologically Evaluable (ME) Analysis Set. | At the test of cure (TOC) (Day 28 to 35) | The proportion of patients meeting the cure criteria: complete resolution or significant improvement of signs and symptoms of the index infection such that no further antibacterial therapy, drainage, or surgical intervention was necessary. |
| The Proportion of Patients With Clinical Cure at the Late Follow up (LFU) Visit in the Microbiologically Evaluable (ME) Analysis Set. | At the late follow up (LFU) (Day 42 to 49) | The proportion of patients meeting the cure criteria: complete resolution or significant improvement of signs and symptoms of the index infection such that no further antibacterial therapy, drainage, or surgical intervention was necessary. |
| The Proportion of Patients With Clinical Cure at the End of Treatment (EOT) Visit in the Extended Microbiologically Evaluable (ME) Analysis Set. | At the end of treatment (EOT) (within 24 hours after last IV dose) | The proportion of patients meeting the cure criteria: complete resolution or significant improvement of signs and symptoms of the index infection such that no further antibacterial therapy, drainage, or surgical intervention was necessary. |
| The Proportion of Patients With Clinical Cure at the Test of Cure (TOC) Visit in the Extended Microbiologically Evaluable (ME) Analysis Set. | At the test of cure (TOC) (Day 28 to 35) | The proportion of patients meeting the cure criteria: complete resolution or significant improvement of signs and symptoms of the index infection such that no further antibacterial therapy, drainage, or surgical intervention was necessary. |
| The Proportion of Patients With Clinical Cure at the Late Follow up (LFU) Visit in the Extended Microbiologically Evaluable (ME) Analysis Set. | At the late follow up (LFU) (Day 42 to 49) | The proportion of patients meeting the cure criteria: complete resolution or significant improvement of signs and symptoms of the index infection such that no further antibacterial therapy, drainage, or surgical intervention was necessary. |
| The Proportion of Patients With Clinical Cure at the End of Treatment (EOT) Visit in the Microbiological Modified Intent-to-treat (mMITT) Analysis Set. | At the end of treatment (EOT) (within 24 hours after last IV dose) | The proportion of patients meeting the cure criteria: complete resolution or significant improvement of signs and symptoms of the index infection such that no further antibacterial therapy, drainage, or surgical intervention was necessary. |
| The Proportion of Patients With Clinical Cure at the Test of Cure (TOC) Visit in the Microbiological Modified Intent-to-treat (mMITT) Analysis Set. | At the test of cure (TOC) (Day 28 to 35) | The proportion of patients meeting the cure criteria: complete resolution or significant improvement of signs and symptoms of the index infection such that no further antibacterial therapy, drainage, or surgical intervention was necessary. |
| The Proportion of Patients With Clinical Cure at the Late Follow up (LFU) Visit in the Microbiological Modified Intent-to-treat (mMITT) Analysis Set. | At the late follow up (LFU) (Day 42 to 49) | The proportion of patients meeting the cure criteria: complete resolution or significant improvement of signs and symptoms of the index infection such that no further antibacterial therapy, drainage, or surgical intervention was necessary. |
| The Proportion of Patients With Clinical Cure at the End of Treatment (EOT) Visit in the Clinically Evaluable (CE) Analysis Set. | At the end of treatment (EOT) (within 24 hours after last IV dose) | The proportion of patients meeting the cure criteria: complete resolution or significant improvement of signs and symptoms of the index infection such that no further antibacterial therapy, drainage, or surgical intervention was necessary. |
| The Proportion of Patients With Clinical Cure at the Late Follow up (LFU) Visit in the Clinically Evaluable (CE) Analysis Set. | At late follow up (LFU) visits (Day 42 to 49) | The proportion of patients meeting the cure criteria: complete resolution or significant improvement of signs and symptoms of the index infection such that no further antibacterial therapy, drainage, or surgical intervention was necessary. |
| The Proportion of Patients With a Favorable Per-patient Microbiological Response at the End of Treatment (EOT) Visit in the Microbiologically Evaluable (ME) Analysis Set. | At the end of treatment (EOT) (within 24 hours after last IV dose) | Per-patient favorable response indicates that all of the patient's baseline pathogens are eradicated or presumed eradicated. |
| The Proportion of Patients With a Favorable Per-patient Microbiological Response at the Test of Cure (TOC) Visit in the Microbiologically Evaluable (ME) Analysis Set. | At the test of cure (TOC) (Day 28 to 35) | Per-patient favorable response indicates that all of the patient's baseline pathogens are eradicated or presumed eradicated. |
| The Proportion of Patients With a Favorable Per-patient Microbiological Response at the Late Follow up (LFU) Visit in the Microbiologically Evaluable (ME) Analysis Set. | At the late follow up (LFU) (Day 42 to 49) | Per-patient favorable response indicates that all of the patient's baseline pathogens are eradicated or presumed eradicated. |
| The Proportion of Patients With a Favorable Per-patient Microbiological Response at the End of Treatment (EOT) Visit in the Extended Microbiologically Evaluable (ME) Analysis Set. | At the end of treatment (EOT) (within 24 hours after last IV dose) | Per-patient favorable response indicates that all of the patient's baseline pathogens are eradicated or presumed eradicated. |
| The Proportion of Patients With a Favorable Per-patient Microbiological Response at the Test of Cure (TOC) Visit in the Extended Microbiologically Evaluable (ME) Analysis Set. | At the test of cure (TOC) (Day 28 to 35) | Per-patient favorable response indicates that all of the patient's baseline pathogens are eradicated or presumed eradicated. |
| The Proportion of Patients With a Favorable Per-patient Microbiological Response at the Late Follow up (LFU) Visit in the Extended Microbiologically Evaluable (ME) Analysis Set. | At the late follow up (LFU) (Day 42 to 49) | Per-patient favorable response indicates that all of the patient's baseline pathogens are eradicated or presumed eradicated. |
| The Proportion of Patients With a Favorable Per-patient Microbiological Response at the End of Treatment (EOT) Visit in the Microbiological Modified Intent-to-treat (mMITT) Analysis Set. | At the end of treatment (EOT) (within 24 hours after last IV dose) | Per-patient favorable response indicates that all of the patient's baseline pathogens are eradicated or presumed eradicated. |
| The Proportion of Patients With a Favorable Per-patient Microbiological Response at the Test of Cure (TOC) Visit in the Microbiological Modified Intent-to-treat (mMITT) Analysis Set. | At the test of cure (TOC) (Day 28 to 35) | Per-patient favorable response indicates that all of the patient's baseline pathogens are eradicated or presumed eradicated. |
| The Proportion of Patients With a Favorable Per-patient Microbiological Response at the Late Follow up (LFU) Visit in the Microbiological Modified Intent-to-treat (mMITT) Analysis Set. | At the late follow up (LFU) (Day 42 to 49) | Per-patient favorable response indicates that all of the patient's baseline pathogens are eradicated or presumed eradicated. |
| The Proportion of Favorable Per-pathogen Microbiological Response at the End of Treatment (EOT) Visit in the Microbiological Modified Intent-to-treat (mMITT) Analysis Set. | At the end of treatment (EOT) (within 24 hours after last IV dose) | The proportion of patients with a favorable per-pathogen microbiological response: favourable microbiological response includes: Eradication Absence of causative pathogen from specimens at the site of infection. Presumed eradication where, repeat cultures were not performed/clinically indicated in a patient who had a clinical response of cure. |
| The Proportion of Favorable Per-pathogen Microbiological Response in the Microbiological Response at the Test of Cure (TOC) Visit in the Microbiological Modified Intent-to-treat (mMITT) Analysis Set. | At the test of cure (TOC) (Day 28 to 35) | The proportion of patients with a favorable per-pathogen microbiological response: favourable microbiological response includes: Eradication Absence of causative pathogen from specimens at the site of infection. Presumed eradication where, repeat cultures were not performed/clinically indicated in a patient who had a clinical response of cure. |
| The Proportion of Favorable Per-pathogen Microbiological Response in the Microbiological Response at the Late Follow up (LFU) Visit in the Microbiological Modified Intent-to-treat (mMITT) Analysis Set. | At the late follow up (LFU) (Day 42 to 49) | The proportion of patients with a favorable per-pathogen microbiological response: favourable microbiological response includes: Eradication Absence of causative pathogen from specimens at the site of infection. Presumed eradication where, repeat cultures were not performed/clinically indicated in a patient who had a clinical response of cure. |
| The Proportion of Favorable Per-pathogen Microbiological Response at the End of Treatment (EOT) Visit in the Microbiologically Evaluable (ME) Analysis Set. | At the end of treatment (EOT) (within 24 hours after last IV dose) | The proportion of patients with a favorable per-pathogen microbiological response: favourable microbiological response includes: Eradication Absence of causative pathogen from specimens at the site of infection. Presumed eradication where, repeat cultures were not performed/clinically indicated in a patient who had a clinical response of cure. |
| The Proportion of Favorable Per-pathogen Microbiological Response at the Test of Cure (TOC) Visit in the Microbiologically Evaluable (ME) Analysis Set. | At the test of cure (TOC) (Day 28 to 35) | The proportion of patients with a favorable per-pathogen microbiological response: favourable microbiological response includes: Eradication Absence of causative pathogen from specimens at the site of infection. Presumed eradication where, repeat cultures were not performed/clinically indicated in a patient who had a clinical response of cure. |
| The Proportion of Favorable Per-pathogen Microbiological Response at the Late Follow up (LFU) Visit in the Microbiologically Evaluable (ME) Analysis Set. | At the late follow up (LFU) (Day 42 to 49) | The proportion of patients with a favorable per-pathogen microbiological response: favourable microbiological response includes: Eradication Absence of causative pathogen from specimens at the site of infection. Presumed eradication where, repeat cultures were not performed/clinically indicated in a patient who had a clinical response of cure. |
| The Proportion of Favorable Per-pathogen Microbiological Response at the End of Treatment (EOT) Visit in the Extended Microbiologically Evaluable (ME) Analysis Set. | At the end of treatment (EOT) (within 24 hours after last IV dose) | The proportion of patients with a favorable per-pathogen microbiological response: favourable microbiological response includes: Eradication Absence of causative pathogen from specimens at the site of infection. Presumed eradication where, repeat cultures were not performed/clinically indicated in a patient who had a clinical response of cure. |
| The Proportion of Favorable Per-pathogen Microbiological Response at the Test of Cure (TOC) Visit in the Extended Microbiologically Evaluable(ME) Analysis Set. | At the test of cure (TOC) (Day 28 to 35) | The proportion of patients with a favorable per-pathogen microbiological response: favourable microbiological response includes: Eradication Absence of causative pathogen from specimens at the site of infection. Presumed eradication where, repeat cultures were not performed/clinically indicated in a patient who had a clinical response of cure. |
| The Proportion of Favorable Per-pathogen Microbiological Response at the Late Follow up (LFU) Visit in the Extended Microbiologically Evaluable (ME) Analysis Set. | At the late follow up (LFU) (Day 42 to 49) | The proportion of patients with a favorable per-pathogen microbiological response: favourable microbiological response includes: Eradication Absence of causative pathogen from specimens at the site of infection. Presumed eradication where, repeat cultures were not performed/clinically indicated in a patient who had a clinical response of cure. |
| The Proportion of Patients With a Favorable Per Patient Microbiological Response at the Test of Cure (TOC) Visit for Patients Infected With Ceftazidime Resistant Pathogens in the Microbiological Modified Intent-to-treat (mMITT) Analysis Set. | At the test of cure (TOC) (Day 28 to 35) | The microbiological responses as per the protocoled criteria: responses other than indeterminate were classified as favorable or unfavorable. Favorable microbiological response assessments included eradication and presumed eradication. Unfavorable microbiological response assessments included persistence, persistence with increasing minimum inhibitory concentration (MIC), and presumed persistence. Indeterminate microbiologic response assessments included cases where the clinical response was changed to indeterminate due to an SRP assessment of inadequate source control (ie, circumstances that preclude classification as eradication, presumed eradication, persistence, persistence with increasing MIC, and presumed persistence). |
| The Proportion of Patients With a Favorable Per Patient Microbiological Response at the Test of Cure (TOC) Visit for Patients Infected With Ceftazidime Resistant Pathogens in the Microbiologically Evaluable (ME) Analysis Set. | At the test of cure (TOC) (Day 28 to 35) | The microbiological responses as per the protocoled criteria: responses other than indeterminate were classified as favorable or unfavorable. Favorable microbiological response assessments included eradication and presumed eradication. Unfavorable microbiological response assessments included persistence, persistence with increasing minimum inhibitory concentration (MIC), and presumed persistence. Indeterminate microbiologic response assessments included cases where the clinical response was changed to indeterminate due to an SRP assessment of inadequate source control (ie, circumstances that preclude classification as eradication, presumed eradication, persistence, persistence with increasing MIC, and presumed persistence). |
| Plasma Concentrations for Ceftazidime and Avibactam | At Day 3: Anytime within 15 minutes prior to or after stopping study drug, anytime between 30 and 90 minutes after stopping study drug, anytime between 300 minutes and 360 minutes after stopping study drug. | Blood samples were taken from all patients on Day 3 for the pharmacokinetic evaluation of ceftazidime and avibactam plasma concentrations |
| The Proportion of Patients With a Favorable Per Patient Microbiological Response at the Test of Cure (TOC) Visit for Patients Infected With Ceftazidime Resistant Pathogens in the Extended Microbiologically Evaluable (ME) Analysis Set. | At the test of cure (TOC) (Day 28 to 35) | The microbiological responses as per the protocoled criteria: responses other than indeterminate were classified as favorable or unfavorable. Favorable microbiological response assessments included eradication and presumed eradication. Unfavorable microbiological response assessments included persistence, persistence with increasing minimum inhibitory concentration (MIC), and presumed persistence. Indeterminate microbiologic response assessments included cases where the clinical response was changed to indeterminate due to an SRP assessment of inadequate source control (ie, circumstances that preclude classification as eradication, presumed eradication, persistence, persistence with increasing MIC, and presumed persistence). |
| The Time to First Defervescence in the Clinically Evaluable (CE) Analysis Set for Patients Who Have Fever at Study Entry. | while on study therapy (from Day 1 to Day 14) | Time to first defervescence was calculated for patients with a fever (\>38ºC) at baseline. Defervescence (≤37.8ºC) was defined as the absence of fever based on the highest temperature recorded on each study day. Time to first defervescence while on IV study therapy in the CE analysis set at TOC for patients who had fever at study entry is defined as time (in days) from the first dose of IV study therapy to first absence of fever. |
| The Time to First Defervescence in the Microbiological Modified Intent-to-treat (mMITT) Analysis Set for Patients Who Have Fever at Study Entry. | while on study therapy (from Day 1 to Day 14) | Time to first defervescence was calculated for patients with a fever (\>38ºC) at baseline. Defervescence (≤37.8ºC) was defined as the absence of fever based on the highest temperature recorded on each study day. Time to first defervescence while on IV study therapy in the CE analysis set at TOC for patients who had fever at study entry is defined as time (in days) from the first dose of IV study therapy to first absence of fever. |
| The Proportion of Patients With Clinical Cure at the End of Treatment (EOT) Visit in the Microbiologically Evaluable (ME) Analysis Set. | At the end of treatment (EOT) (within 24 hours after last IV dose) | The proportion of patients meeting the cure criteria: complete resolution or significant improvement of signs and symptoms of the index infection such that no further antibacterial therapy, drainage, or surgical intervention was necessary. |
| Safety and Tolerability by Incidence: Extent of Exposure. | study duration (from screening to Day 49 LFU visit) | Duration of exposure is calculated as the difference between the last study therapy date and the first study therapy date converted to days plus 1 day. Actual calculated duration could be shorter or longer than a full day. |
| Safety and Tolerability: Clinical Laboratory Evaluation Hematology. | study duration (from screening to Day 49 LFU visit) | Potentially clinically significant (PCS) post Baseline hematology values up to LFU (Safety analysis set) |
| Safety and Tolerability: Clinical Laboratory Evaluation Clinical Chemistry. | study duration (from screening to Day 49 LFU visit) | Potentially clinically significant (PCS) post Baseline clinical chemistry values up to LFU (Safety analysis set) |
| Safety and Tolerability:ECG , QTcB and QTcF Intervals | EOT visit/any observation on treatment | Shifts in ECG interpretation and changes in QT, QTcB, and QTcF intervals , from baseline to post baseline. |
| Safety and Tolerability by Incidence and Severity of Adverse Events and Serious Adverse Events and Mortality. | study duration (from screening to Day 49 LFU visit) | Adverse event data were collected from the screening/consent visit until the late follow-up visit (i.e. Day -1/0 to Day 42). |
Countries
China, South Korea, Vietnam
Participant flow
Recruitment details
Overall, 486 patients were enrolled from 43 centers in 3 countries in this study. The first patient was enrolled on 14 January 2013 and the last patient last visit was on 14 March 2015.
Pre-assignment details
Of 486 enrolled patients, 42 did not meet the eligibility criteria. A further two patients were not randomized due to withdrawn consent, and one patient was not randomized due to unavailability of study drug.
Participants by arm
| Arm | Count |
|---|---|
| Ceftazidime-Avibactam Plus Metronidazole Ceftazidime-Avibactam powder for concentrate for solution for infusion 2000 mg/500 mg Plus Metronidazole 500mg/100ml solution for infusion | 214 |
| Meropenem Meropenem powder for solution for infusion 1000mg | 217 |
| Total | 431 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 1 | 1 |
| Overall Study | Lost to Follow-up | 5 | 10 |
| Overall Study | Other Eligibility criteria | 7 | 7 |
| Overall Study | Withdrawal by Subject | 16 | 8 |
Baseline characteristics
| Characteristic | Ceftazidime-Avibactam Plus Metronidazole | Meropenem | Total |
|---|---|---|---|
| Age, Continuous | 48.5 Years STANDARD_DEVIATION 16.83 | 48.5 Years STANDARD_DEVIATION 17.43 | 48.5 Years STANDARD_DEVIATION 17.11 |
| Age, Customized 18-45 Years | 89 Participants | 96 Participants | 185 Participants |
| Age, Customized 46-64 Years | 85 Participants | 72 Participants | 157 Participants |
| Age, Customized 65-74 Years | 28 Participants | 30 Participants | 58 Participants |
| Age, Customized 75-90 Years | 12 Participants | 19 Participants | 31 Participants |
| Race/Ethnicity, Customized Asian | 214 Participants | 217 Participants | 431 Participants |
| Sex: Female, Male Female | 73 Participants | 64 Participants | 137 Participants |
| Sex: Female, Male Male | 141 Participants | 153 Participants | 294 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 44 / 215 | 47 / 217 |
| serious Total, serious adverse events | 9 / 215 | 11 / 217 |
Outcome results
Primary
The Proportion of Patients With Clinical Cure at the Test of Cure (TOC) Visit in the Clinically Evaluable (CE) Analysis Set.
The proportion of patients meeting the cure criteria: complete resolution or significant improvement of signs and symptoms of the index infection such that no further antibacterial therapy, drainage, or surgical intervention was necessary.
Time frame: At the test of cure visit (Day 28 to35)
Population: The clinically evaluable (CE) analysis set included all patients who met the disease definition of cIAI and met the stringent criteria for clinical evaluation described in the protocol regarding dosing, concomitant medication, evaluation, etc.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ceftazidime-Avibactam Plus Metronidazole | The Proportion of Patients With Clinical Cure at the Test of Cure (TOC) Visit in the Clinically Evaluable (CE) Analysis Set. | Clinical cure | 166 Number of patients |
| Ceftazidime-Avibactam Plus Metronidazole | The Proportion of Patients With Clinical Cure at the Test of Cure (TOC) Visit in the Clinically Evaluable (CE) Analysis Set. | Clinical failure | 11 Number of patients |
| Meropenem | The Proportion of Patients With Clinical Cure at the Test of Cure (TOC) Visit in the Clinically Evaluable (CE) Analysis Set. | Clinical cure | 173 Number of patients |
| Meropenem | The Proportion of Patients With Clinical Cure at the Test of Cure (TOC) Visit in the Clinically Evaluable (CE) Analysis Set. | Clinical failure | 11 Number of patients |
Comparison: The Primary objective of this study was to assess the non inferiority (based on a 12.5% margin) of CAZ AVI plus metronidazole compared to meropenem alone with respect to clinical cure at the TOC visit in patients who were CE.p-value: <0.00195% CI: [-5.53, 4.97]% Risk Difference (RD)
Secondary
Plasma Concentrations for Ceftazidime and Avibactam
Blood samples were taken from all patients on Day 3 for the pharmacokinetic evaluation of ceftazidime and avibactam plasma concentrations
Time frame: At Day 3: Anytime within 15 minutes prior to or after stopping study drug, anytime between 30 and 90 minutes after stopping study drug, anytime between 300 minutes and 360 minutes after stopping study drug.
Population: PK analysis set
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Ceftazidime-Avibactam Plus Metronidazole | Plasma Concentrations for Ceftazidime and Avibactam | 60300.4 ng/mL |
| Meropenem | Plasma Concentrations for Ceftazidime and Avibactam | 10126.9 ng/mL |
| Ceftazidime(2) | Plasma Concentrations for Ceftazidime and Avibactam | 46473.9 ng/mL |
| Avibactam(2) | Plasma Concentrations for Ceftazidime and Avibactam | 7289.3 ng/mL |
| Ceftazidime(3) | Plasma Concentrations for Ceftazidime and Avibactam | 9555.0 ng/mL |
| Avibactam(3) | Plasma Concentrations for Ceftazidime and Avibactam | 1207.2 ng/mL |
Secondary
Safety and Tolerability by Incidence and Severity of Adverse Events and Serious Adverse Events and Mortality.
Adverse event data were collected from the screening/consent visit until the late follow-up visit (i.e. Day -1/0 to Day 42).
Time frame: study duration (from screening to Day 49 LFU visit)
Population: Safety analysis set: all patients who received at least 1 dose of IP
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ceftazidime-Avibactam Plus Metronidazole | Safety and Tolerability by Incidence and Severity of Adverse Events and Serious Adverse Events and Mortality. | Any AE leading to discontinuation of IP | 7 Number of patients |
| Ceftazidime-Avibactam Plus Metronidazole | Safety and Tolerability by Incidence and Severity of Adverse Events and Serious Adverse Events and Mortality. | Any AE with outcome=death | 0 Number of patients |
| Ceftazidime-Avibactam Plus Metronidazole | Safety and Tolerability by Incidence and Severity of Adverse Events and Serious Adverse Events and Mortality. | Any AE of severe intensity | 5 Number of patients |
| Ceftazidime-Avibactam Plus Metronidazole | Safety and Tolerability by Incidence and Severity of Adverse Events and Serious Adverse Events and Mortality. | Any SAE | 9 Number of patients |
| Ceftazidime-Avibactam Plus Metronidazole | Safety and Tolerability by Incidence and Severity of Adverse Events and Serious Adverse Events and Mortality. | Total number of deaths | 2 Number of patients |
| Ceftazidime-Avibactam Plus Metronidazole | Safety and Tolerability by Incidence and Severity of Adverse Events and Serious Adverse Events and Mortality. | Deaths due to disease progression | 2 Number of patients |
| Ceftazidime-Avibactam Plus Metronidazole | Safety and Tolerability by Incidence and Severity of Adverse Events and Serious Adverse Events and Mortality. | Any AE | 82 Number of patients |
| Meropenem | Safety and Tolerability by Incidence and Severity of Adverse Events and Serious Adverse Events and Mortality. | Deaths due to disease progression | 0 Number of patients |
| Meropenem | Safety and Tolerability by Incidence and Severity of Adverse Events and Serious Adverse Events and Mortality. | Any AE with outcome=death | 1 Number of patients |
| Meropenem | Safety and Tolerability by Incidence and Severity of Adverse Events and Serious Adverse Events and Mortality. | Any AE | 83 Number of patients |
| Meropenem | Safety and Tolerability by Incidence and Severity of Adverse Events and Serious Adverse Events and Mortality. | Any SAE | 11 Number of patients |
| Meropenem | Safety and Tolerability by Incidence and Severity of Adverse Events and Serious Adverse Events and Mortality. | Any AE leading to discontinuation of IP | 3 Number of patients |
| Meropenem | Safety and Tolerability by Incidence and Severity of Adverse Events and Serious Adverse Events and Mortality. | Any AE of severe intensity | 5 Number of patients |
| Meropenem | Safety and Tolerability by Incidence and Severity of Adverse Events and Serious Adverse Events and Mortality. | Total number of deaths | 1 Number of patients |
Secondary
Safety and Tolerability by Incidence: Extent of Exposure.
Duration of exposure is calculated as the difference between the last study therapy date and the first study therapy date converted to days plus 1 day. Actual calculated duration could be shorter or longer than a full day.
Time frame: study duration (from screening to Day 49 LFU visit)
Population: Safety analysis set: all patients who received at least 1 dose of IP
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ceftazidime-Avibactam Plus Metronidazole | Safety and Tolerability by Incidence: Extent of Exposure. | 1 - 2 days | 10 Number of patients |
| Ceftazidime-Avibactam Plus Metronidazole | Safety and Tolerability by Incidence: Extent of Exposure. | 3 - 4 days | 6 Number of patients |
| Ceftazidime-Avibactam Plus Metronidazole | Safety and Tolerability by Incidence: Extent of Exposure. | 5 -10 days | 175 Number of patients |
| Ceftazidime-Avibactam Plus Metronidazole | Safety and Tolerability by Incidence: Extent of Exposure. | 11 - 14 days | 24 Number of patients |
| Ceftazidime-Avibactam Plus Metronidazole | Safety and Tolerability by Incidence: Extent of Exposure. | >14 days | 0 Number of patients |
| Meropenem | Safety and Tolerability by Incidence: Extent of Exposure. | >14 days | 0 Number of patients |
| Meropenem | Safety and Tolerability by Incidence: Extent of Exposure. | 11 - 14 days | 26 Number of patients |
| Meropenem | Safety and Tolerability by Incidence: Extent of Exposure. | 3 - 4 days | 5 Number of patients |
| Meropenem | Safety and Tolerability by Incidence: Extent of Exposure. | 1 - 2 days | 5 Number of patients |
| Meropenem | Safety and Tolerability by Incidence: Extent of Exposure. | 5 -10 days | 181 Number of patients |
Secondary
Safety and Tolerability: Clinical Laboratory Evaluation Clinical Chemistry.
Potentially clinically significant (PCS) post Baseline clinical chemistry values up to LFU (Safety analysis set)
Time frame: study duration (from screening to Day 49 LFU visit)
Population: Safety analysis set: all patients who received at least 1 dose of IP
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ceftazidime-Avibactam Plus Metronidazole | Safety and Tolerability: Clinical Laboratory Evaluation Clinical Chemistry. | Creatinine (μmol/L): PCS (High) | 0 Number of patients |
| Ceftazidime-Avibactam Plus Metronidazole | Safety and Tolerability: Clinical Laboratory Evaluation Clinical Chemistry. | Bicarbonate (mmol/L) PCS (Low) | 1 Number of patients |
| Ceftazidime-Avibactam Plus Metronidazole | Safety and Tolerability: Clinical Laboratory Evaluation Clinical Chemistry. | Potassium (mmol/L): PCS (High) | 3 Number of patients |
| Ceftazidime-Avibactam Plus Metronidazole | Safety and Tolerability: Clinical Laboratory Evaluation Clinical Chemistry. | Bicarbonate (mmol/L): PCS (High) | 0 Number of patients |
| Ceftazidime-Avibactam Plus Metronidazole | Safety and Tolerability: Clinical Laboratory Evaluation Clinical Chemistry. | Alanine aminotransferase (μkat/L): PCS (High) | 3 Number of patients |
| Ceftazidime-Avibactam Plus Metronidazole | Safety and Tolerability: Clinical Laboratory Evaluation Clinical Chemistry. | Glucose (non-fasting) (mmol/L): PCS (High) | 1 Number of patients |
| Ceftazidime-Avibactam Plus Metronidazole | Safety and Tolerability: Clinical Laboratory Evaluation Clinical Chemistry. | Gamma-glutamyl transferase (μkat/L):PCS (High) | 2 Number of patients |
| Ceftazidime-Avibactam Plus Metronidazole | Safety and Tolerability: Clinical Laboratory Evaluation Clinical Chemistry. | Alkaline phosphatase (μkat/L): PCS (Low) | 0 Number of patients |
| Ceftazidime-Avibactam Plus Metronidazole | Safety and Tolerability: Clinical Laboratory Evaluation Clinical Chemistry. | Inorganic phosphorus (mmol/L): PCS (High) | 0 Number of patients |
| Ceftazidime-Avibactam Plus Metronidazole | Safety and Tolerability: Clinical Laboratory Evaluation Clinical Chemistry. | Inorganic phosphorus (mmol/L): PCS (Low) | 3 Number of patients |
| Ceftazidime-Avibactam Plus Metronidazole | Safety and Tolerability: Clinical Laboratory Evaluation Clinical Chemistry. | Potassium (mmol/L): PCS (Low) | 9 Number of patients |
| Ceftazidime-Avibactam Plus Metronidazole | Safety and Tolerability: Clinical Laboratory Evaluation Clinical Chemistry. | Alkaline phosphatase (μkat/L): PCS (High) | 2 Number of patients |
| Ceftazidime-Avibactam Plus Metronidazole | Safety and Tolerability: Clinical Laboratory Evaluation Clinical Chemistry. | Total bilirubin (μmol/L): PCS (High) | 0 Number of patients |
| Ceftazidime-Avibactam Plus Metronidazole | Safety and Tolerability: Clinical Laboratory Evaluation Clinical Chemistry. | Glucose (non-fasting) (mmol/L): PCS (Low) | 0 Number of patients |
| Ceftazidime-Avibactam Plus Metronidazole | Safety and Tolerability: Clinical Laboratory Evaluation Clinical Chemistry. | Direct bilirubin (μmol/L): PCS (High) | 1 Number of patients |
| Ceftazidime-Avibactam Plus Metronidazole | Safety and Tolerability: Clinical Laboratory Evaluation Clinical Chemistry. | Aspartate aminotransferase (μkat/L): PCS (High) | 4 Number of patients |
| Meropenem | Safety and Tolerability: Clinical Laboratory Evaluation Clinical Chemistry. | Direct bilirubin (μmol/L): PCS (High) | 1 Number of patients |
| Meropenem | Safety and Tolerability: Clinical Laboratory Evaluation Clinical Chemistry. | Glucose (non-fasting) (mmol/L): PCS (Low) | 0 Number of patients |
| Meropenem | Safety and Tolerability: Clinical Laboratory Evaluation Clinical Chemistry. | Inorganic phosphorus (mmol/L): PCS (Low) | 7 Number of patients |
| Meropenem | Safety and Tolerability: Clinical Laboratory Evaluation Clinical Chemistry. | Potassium (mmol/L): PCS (Low) | 5 Number of patients |
| Meropenem | Safety and Tolerability: Clinical Laboratory Evaluation Clinical Chemistry. | Alanine aminotransferase (μkat/L): PCS (High) | 8 Number of patients |
| Meropenem | Safety and Tolerability: Clinical Laboratory Evaluation Clinical Chemistry. | Alkaline phosphatase (μkat/L): PCS (Low) | 0 Number of patients |
| Meropenem | Safety and Tolerability: Clinical Laboratory Evaluation Clinical Chemistry. | Alkaline phosphatase (μkat/L): PCS (High) | 3 Number of patients |
| Meropenem | Safety and Tolerability: Clinical Laboratory Evaluation Clinical Chemistry. | Aspartate aminotransferase (μkat/L): PCS (High) | 4 Number of patients |
| Meropenem | Safety and Tolerability: Clinical Laboratory Evaluation Clinical Chemistry. | Bicarbonate (mmol/L) PCS (Low) | 0 Number of patients |
| Meropenem | Safety and Tolerability: Clinical Laboratory Evaluation Clinical Chemistry. | Creatinine (μmol/L): PCS (High) | 1 Number of patients |
| Meropenem | Safety and Tolerability: Clinical Laboratory Evaluation Clinical Chemistry. | Glucose (non-fasting) (mmol/L): PCS (High) | 1 Number of patients |
| Meropenem | Safety and Tolerability: Clinical Laboratory Evaluation Clinical Chemistry. | Gamma-glutamyl transferase (μkat/L):PCS (High) | 4 Number of patients |
| Meropenem | Safety and Tolerability: Clinical Laboratory Evaluation Clinical Chemistry. | Inorganic phosphorus (mmol/L): PCS (High) | 0 Number of patients |
| Meropenem | Safety and Tolerability: Clinical Laboratory Evaluation Clinical Chemistry. | Potassium (mmol/L): PCS (High) | 1 Number of patients |
| Meropenem | Safety and Tolerability: Clinical Laboratory Evaluation Clinical Chemistry. | Total bilirubin (μmol/L): PCS (High) | 1 Number of patients |
| Meropenem | Safety and Tolerability: Clinical Laboratory Evaluation Clinical Chemistry. | Bicarbonate (mmol/L): PCS (High) | 0 Number of patients |
Secondary
Safety and Tolerability: Clinical Laboratory Evaluation Hematology.
Potentially clinically significant (PCS) post Baseline hematology values up to LFU (Safety analysis set)
Time frame: study duration (from screening to Day 49 LFU visit)
Population: Safety analysis set: all patients who received at least 1 dose of IP
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ceftazidime-Avibactam Plus Metronidazole | Safety and Tolerability: Clinical Laboratory Evaluation Hematology. | White blood cell: PCS (Low) | 1 Number of patients |
| Ceftazidime-Avibactam Plus Metronidazole | Safety and Tolerability: Clinical Laboratory Evaluation Hematology. | Red blood cell count: PCS (High) | 0 Number of patients |
| Ceftazidime-Avibactam Plus Metronidazole | Safety and Tolerability: Clinical Laboratory Evaluation Hematology. | White blood cell: PCS (High) | 4 Number of patients |
| Ceftazidime-Avibactam Plus Metronidazole | Safety and Tolerability: Clinical Laboratory Evaluation Hematology. | Lymphocytes: PCS (Low) | 1 Number of patients |
| Ceftazidime-Avibactam Plus Metronidazole | Safety and Tolerability: Clinical Laboratory Evaluation Hematology. | Lymphocytes: PCS (High) | 0 Number of patients |
| Ceftazidime-Avibactam Plus Metronidazole | Safety and Tolerability: Clinical Laboratory Evaluation Hematology. | Hematocrit (ratio): PCS (High) | 0 Number of patients |
| Ceftazidime-Avibactam Plus Metronidazole | Safety and Tolerability: Clinical Laboratory Evaluation Hematology. | Hemoglobin: PCS (Low) | 7 Number of patients |
| Ceftazidime-Avibactam Plus Metronidazole | Safety and Tolerability: Clinical Laboratory Evaluation Hematology. | Hemoglobin: PCS (High) | 0 Number of patients |
| Ceftazidime-Avibactam Plus Metronidazole | Safety and Tolerability: Clinical Laboratory Evaluation Hematology. | Neutrophils: PCS (Low) | 4 Number of patients |
| Ceftazidime-Avibactam Plus Metronidazole | Safety and Tolerability: Clinical Laboratory Evaluation Hematology. | Neutrophils: PCS (High) | 9 Number of patients |
| Ceftazidime-Avibactam Plus Metronidazole | Safety and Tolerability: Clinical Laboratory Evaluation Hematology. | Eosinophils: PCS (High) | 0 Number of patients |
| Ceftazidime-Avibactam Plus Metronidazole | Safety and Tolerability: Clinical Laboratory Evaluation Hematology. | Monocytes: PCS (High) | 0 Number of patients |
| Ceftazidime-Avibactam Plus Metronidazole | Safety and Tolerability: Clinical Laboratory Evaluation Hematology. | Basophils: PCS (High) | 0 Number of patients |
| Ceftazidime-Avibactam Plus Metronidazole | Safety and Tolerability: Clinical Laboratory Evaluation Hematology. | Direct Coombs test:- at Baseline, + post-Baseline | 15 Number of patients |
| Ceftazidime-Avibactam Plus Metronidazole | Safety and Tolerability: Clinical Laboratory Evaluation Hematology. | Hematocrit (ratio): PCS (Low) | 5 Number of patients |
| Ceftazidime-Avibactam Plus Metronidazole | Safety and Tolerability: Clinical Laboratory Evaluation Hematology. | Platelet count: PCS (Low) | 1 Number of patients |
| Ceftazidime-Avibactam Plus Metronidazole | Safety and Tolerability: Clinical Laboratory Evaluation Hematology. | Platelet count: PCS (High) | 5 Number of patients |
| Ceftazidime-Avibactam Plus Metronidazole | Safety and Tolerability: Clinical Laboratory Evaluation Hematology. | Red blood cell count: PCS (Low) | 7 Number of patients |
| Meropenem | Safety and Tolerability: Clinical Laboratory Evaluation Hematology. | Red blood cell count: PCS (High) | 0 Number of patients |
| Meropenem | Safety and Tolerability: Clinical Laboratory Evaluation Hematology. | Red blood cell count: PCS (Low) | 13 Number of patients |
| Meropenem | Safety and Tolerability: Clinical Laboratory Evaluation Hematology. | Neutrophils: PCS (High) | 8 Number of patients |
| Meropenem | Safety and Tolerability: Clinical Laboratory Evaluation Hematology. | White blood cell: PCS (Low) | 1 Number of patients |
| Meropenem | Safety and Tolerability: Clinical Laboratory Evaluation Hematology. | Hematocrit (ratio): PCS (Low) | 8 Number of patients |
| Meropenem | Safety and Tolerability: Clinical Laboratory Evaluation Hematology. | Eosinophils: PCS (High) | 0 Number of patients |
| Meropenem | Safety and Tolerability: Clinical Laboratory Evaluation Hematology. | Lymphocytes: PCS (Low) | 1 Number of patients |
| Meropenem | Safety and Tolerability: Clinical Laboratory Evaluation Hematology. | Hematocrit (ratio): PCS (High) | 0 Number of patients |
| Meropenem | Safety and Tolerability: Clinical Laboratory Evaluation Hematology. | Lymphocytes: PCS (High) | 1 Number of patients |
| Meropenem | Safety and Tolerability: Clinical Laboratory Evaluation Hematology. | Direct Coombs test:- at Baseline, + post-Baseline | 2 Number of patients |
| Meropenem | Safety and Tolerability: Clinical Laboratory Evaluation Hematology. | Monocytes: PCS (High) | 0 Number of patients |
| Meropenem | Safety and Tolerability: Clinical Laboratory Evaluation Hematology. | White blood cell: PCS (High) | 5 Number of patients |
| Meropenem | Safety and Tolerability: Clinical Laboratory Evaluation Hematology. | Platelet count: PCS (High) | 4 Number of patients |
| Meropenem | Safety and Tolerability: Clinical Laboratory Evaluation Hematology. | Hemoglobin: PCS (Low) | 14 Number of patients |
| Meropenem | Safety and Tolerability: Clinical Laboratory Evaluation Hematology. | Basophils: PCS (High) | 0 Number of patients |
| Meropenem | Safety and Tolerability: Clinical Laboratory Evaluation Hematology. | Hemoglobin: PCS (High) | 0 Number of patients |
| Meropenem | Safety and Tolerability: Clinical Laboratory Evaluation Hematology. | Platelet count: PCS (Low) | 1 Number of patients |
| Meropenem | Safety and Tolerability: Clinical Laboratory Evaluation Hematology. | Neutrophils: PCS (Low) | 2 Number of patients |
Secondary
Safety and Tolerability:ECG , QTcB and QTcF Intervals
Shifts in ECG interpretation and changes in QT, QTcB, and QTcF intervals , from baseline to post baseline.
Time frame: EOT visit/any observation on treatment
Population: Safety analysis set: all patients who received at least 1 dose of IP
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ceftazidime-Avibactam Plus Metronidazole | Safety and Tolerability:ECG , QTcB and QTcF Intervals | Normal to Abnormal: Anytime up to EOT | 34 Number of patients |
| Ceftazidime-Avibactam Plus Metronidazole | Safety and Tolerability:ECG , QTcB and QTcF Intervals | Reaching a value in QT: ≥450 (ms) | 9 Number of patients |
| Ceftazidime-Avibactam Plus Metronidazole | Safety and Tolerability:ECG , QTcB and QTcF Intervals | QT: ≥500 and increase from Baseline ≥60(ms) | 0 Number of patients |
| Ceftazidime-Avibactam Plus Metronidazole | Safety and Tolerability:ECG , QTcB and QTcF Intervals | Reaching a value in QTcF: ≥480 (ms) | 4 Number of patients |
| Ceftazidime-Avibactam Plus Metronidazole | Safety and Tolerability:ECG , QTcB and QTcF Intervals | Normal to Abnormal: EOT | 17 Number of patients |
| Ceftazidime-Avibactam Plus Metronidazole | Safety and Tolerability:ECG , QTcB and QTcF Intervals | Reaching a value in QT: ≥480 (ms) | 2 Number of patients |
| Ceftazidime-Avibactam Plus Metronidazole | Safety and Tolerability:ECG , QTcB and QTcF Intervals | Reaching a value in QT: ≥500 (ms) | 0 Number of patients |
| Ceftazidime-Avibactam Plus Metronidazole | Safety and Tolerability:ECG , QTcB and QTcF Intervals | Increase in QT: ≥30 (ms) | 115 Number of patients |
| Ceftazidime-Avibactam Plus Metronidazole | Safety and Tolerability:ECG , QTcB and QTcF Intervals | Increase in QT: ≥60 (ms) | 50 Number of patients |
| Ceftazidime-Avibactam Plus Metronidazole | Safety and Tolerability:ECG , QTcB and QTcF Intervals | Decrease in QT: ≥30 (ms) | 24 Number of patients |
| Ceftazidime-Avibactam Plus Metronidazole | Safety and Tolerability:ECG , QTcB and QTcF Intervals | Decrease in QT: ≥60 (ms) | 12 Number of patients |
| Ceftazidime-Avibactam Plus Metronidazole | Safety and Tolerability:ECG , QTcB and QTcF Intervals | Reaching a value in QTcB: ≥450(ms) | 57 Number of patients |
| Ceftazidime-Avibactam Plus Metronidazole | Safety and Tolerability:ECG , QTcB and QTcF Intervals | Reaching a value in QTcB: ≥480(ms) | 13 Number of patients |
| Ceftazidime-Avibactam Plus Metronidazole | Safety and Tolerability:ECG , QTcB and QTcF Intervals | Reaching a value in QTcB: ≥500 (ms) | 4 Number of patients |
| Ceftazidime-Avibactam Plus Metronidazole | Safety and Tolerability:ECG , QTcB and QTcF Intervals | QTcB: ≥500 and increase from Baseline ≥60(ms) | 2 Number of patients |
| Ceftazidime-Avibactam Plus Metronidazole | Safety and Tolerability:ECG , QTcB and QTcF Intervals | Increase in QTcB: ≥30 (ms) | 21 Number of patients |
| Ceftazidime-Avibactam Plus Metronidazole | Safety and Tolerability:ECG , QTcB and QTcF Intervals | Increase in QTcB: ≥60 (ms) | 2 Number of patients |
| Ceftazidime-Avibactam Plus Metronidazole | Safety and Tolerability:ECG , QTcB and QTcF Intervals | Decrease in QTcB: ≥30 (ms) | 42 Number of patients |
| Ceftazidime-Avibactam Plus Metronidazole | Safety and Tolerability:ECG , QTcB and QTcF Intervals | Decrease in QTcB: ≥60 (ms) | 6 Number of patients |
| Ceftazidime-Avibactam Plus Metronidazole | Safety and Tolerability:ECG , QTcB and QTcF Intervals | Reaching a value in QTcF: ≥450 (ms) | 19 Number of patients |
| Ceftazidime-Avibactam Plus Metronidazole | Safety and Tolerability:ECG , QTcB and QTcF Intervals | Reaching a value in QTcF: ≥500 (ms) | 1 Number of patients |
| Ceftazidime-Avibactam Plus Metronidazole | Safety and Tolerability:ECG , QTcB and QTcF Intervals | QTcF: ≥500 and increase from Baseline ≥60 (ms) | 0 Number of patients |
| Ceftazidime-Avibactam Plus Metronidazole | Safety and Tolerability:ECG , QTcB and QTcF Intervals | Increase in QTcF: ≥30 (ms) | 42 Number of patients |
| Ceftazidime-Avibactam Plus Metronidazole | Safety and Tolerability:ECG , QTcB and QTcF Intervals | Increase in QTcF: ≥60 (ms) | 4 Number of patients |
| Ceftazidime-Avibactam Plus Metronidazole | Safety and Tolerability:ECG , QTcB and QTcF Intervals | Decrease QTcF: ≥30 (ms) | 21 Number of patients |
| Ceftazidime-Avibactam Plus Metronidazole | Safety and Tolerability:ECG , QTcB and QTcF Intervals | Decrease QTcF: ≥60 (ms) | 7 Number of patients |
| Meropenem | Safety and Tolerability:ECG , QTcB and QTcF Intervals | Reaching a value in QTcF: ≥450 (ms) | 18 Number of patients |
| Meropenem | Safety and Tolerability:ECG , QTcB and QTcF Intervals | Normal to Abnormal: Anytime up to EOT | 30 Number of patients |
| Meropenem | Safety and Tolerability:ECG , QTcB and QTcF Intervals | Reaching a value in QTcB: ≥500 (ms) | 2 Number of patients |
| Meropenem | Safety and Tolerability:ECG , QTcB and QTcF Intervals | Reaching a value in QTcF: ≥480 (ms) | 0 Number of patients |
| Meropenem | Safety and Tolerability:ECG , QTcB and QTcF Intervals | QT: ≥500 and increase from Baseline ≥60(ms) | 0 Number of patients |
| Meropenem | Safety and Tolerability:ECG , QTcB and QTcF Intervals | QTcB: ≥500 and increase from Baseline ≥60(ms) | 1 Number of patients |
| Meropenem | Safety and Tolerability:ECG , QTcB and QTcF Intervals | Decrease QTcF: ≥30 (ms) | 19 Number of patients |
| Meropenem | Safety and Tolerability:ECG , QTcB and QTcF Intervals | Increase in QTcF: ≥30 (ms) | 41 Number of patients |
| Meropenem | Safety and Tolerability:ECG , QTcB and QTcF Intervals | Normal to Abnormal: EOT | 14 Number of patients |
| Meropenem | Safety and Tolerability:ECG , QTcB and QTcF Intervals | Reaching a value in QT: ≥450 (ms) | 10 Number of patients |
| Meropenem | Safety and Tolerability:ECG , QTcB and QTcF Intervals | Increase in QTcB: ≥30 (ms) | 27 Number of patients |
| Meropenem | Safety and Tolerability:ECG , QTcB and QTcF Intervals | Reaching a value in QT: ≥480 (ms) | 1 Number of patients |
| Meropenem | Safety and Tolerability:ECG , QTcB and QTcF Intervals | Reaching a value in QTcF: ≥500 (ms) | 0 Number of patients |
| Meropenem | Safety and Tolerability:ECG , QTcB and QTcF Intervals | Reaching a value in QT: ≥500 (ms) | 0 Number of patients |
| Meropenem | Safety and Tolerability:ECG , QTcB and QTcF Intervals | Increase in QTcB: ≥60 (ms) | 1 Number of patients |
| Meropenem | Safety and Tolerability:ECG , QTcB and QTcF Intervals | Increase in QT: ≥30 (ms) | 114 Number of patients |
| Meropenem | Safety and Tolerability:ECG , QTcB and QTcF Intervals | Decrease QTcF: ≥60 (ms) | 1 Number of patients |
| Meropenem | Safety and Tolerability:ECG , QTcB and QTcF Intervals | Increase in QT: ≥60 (ms) | 44 Number of patients |
| Meropenem | Safety and Tolerability:ECG , QTcB and QTcF Intervals | Decrease in QTcB: ≥30 (ms) | 26 Number of patients |
| Meropenem | Safety and Tolerability:ECG , QTcB and QTcF Intervals | Decrease in QT: ≥30 (ms) | 24 Number of patients |
| Meropenem | Safety and Tolerability:ECG , QTcB and QTcF Intervals | QTcF: ≥500 and increase from Baseline ≥60 (ms) | 0 Number of patients |
| Meropenem | Safety and Tolerability:ECG , QTcB and QTcF Intervals | Decrease in QT: ≥60 (ms) | 4 Number of patients |
| Meropenem | Safety and Tolerability:ECG , QTcB and QTcF Intervals | Decrease in QTcB: ≥60 (ms) | 4 Number of patients |
| Meropenem | Safety and Tolerability:ECG , QTcB and QTcF Intervals | Reaching a value in QTcB: ≥450(ms) | 63 Number of patients |
| Meropenem | Safety and Tolerability:ECG , QTcB and QTcF Intervals | Increase in QTcF: ≥60 (ms) | 3 Number of patients |
| Meropenem | Safety and Tolerability:ECG , QTcB and QTcF Intervals | Reaching a value in QTcB: ≥480(ms) | 8 Number of patients |
Secondary
The Proportion of Favorable Per-pathogen Microbiological Response at the End of Treatment (EOT) Visit in the Extended Microbiologically Evaluable (ME) Analysis Set.
The proportion of patients with a favorable per-pathogen microbiological response: favourable microbiological response includes: Eradication Absence of causative pathogen from specimens at the site of infection. Presumed eradication where, repeat cultures were not performed/clinically indicated in a patient who had a clinical response of cure.
Time frame: At the end of treatment (EOT) (within 24 hours after last IV dose)
Population: Extended microbiologically evaluable(ME) analysis set defined as all patients included in the clinically evaluable (CE) set with at least 1 Gram-negative aerobic pathogen in the initial/prestudy culture regardless of susceptibility.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ceftazidime-Avibactam Plus Metronidazole | The Proportion of Favorable Per-pathogen Microbiological Response at the End of Treatment (EOT) Visit in the Extended Microbiologically Evaluable (ME) Analysis Set. | Escherichia coli (n=70, 80) | 69 Participants with favorable responses |
| Ceftazidime-Avibactam Plus Metronidazole | The Proportion of Favorable Per-pathogen Microbiological Response at the End of Treatment (EOT) Visit in the Extended Microbiologically Evaluable (ME) Analysis Set. | Klebsiella pneumoniae (n=22, 30) | 21 Participants with favorable responses |
| Ceftazidime-Avibactam Plus Metronidazole | The Proportion of Favorable Per-pathogen Microbiological Response at the End of Treatment (EOT) Visit in the Extended Microbiologically Evaluable (ME) Analysis Set. | Pseudomonas aeruginosa (n=14, 18) | 14 Participants with favorable responses |
| Ceftazidime-Avibactam Plus Metronidazole | The Proportion of Favorable Per-pathogen Microbiological Response at the End of Treatment (EOT) Visit in the Extended Microbiologically Evaluable (ME) Analysis Set. | Klebsiella oxytoca (n=5, 5) | 5 Participants with favorable responses |
| Meropenem | The Proportion of Favorable Per-pathogen Microbiological Response at the End of Treatment (EOT) Visit in the Extended Microbiologically Evaluable (ME) Analysis Set. | Pseudomonas aeruginosa (n=14, 18) | 16 Participants with favorable responses |
| Meropenem | The Proportion of Favorable Per-pathogen Microbiological Response at the End of Treatment (EOT) Visit in the Extended Microbiologically Evaluable (ME) Analysis Set. | Escherichia coli (n=70, 80) | 78 Participants with favorable responses |
| Meropenem | The Proportion of Favorable Per-pathogen Microbiological Response at the End of Treatment (EOT) Visit in the Extended Microbiologically Evaluable (ME) Analysis Set. | Klebsiella oxytoca (n=5, 5) | 5 Participants with favorable responses |
| Meropenem | The Proportion of Favorable Per-pathogen Microbiological Response at the End of Treatment (EOT) Visit in the Extended Microbiologically Evaluable (ME) Analysis Set. | Klebsiella pneumoniae (n=22, 30) | 29 Participants with favorable responses |
Secondary
The Proportion of Favorable Per-pathogen Microbiological Response at the End of Treatment (EOT) Visit in the Microbiologically Evaluable (ME) Analysis Set.
The proportion of patients with a favorable per-pathogen microbiological response: favourable microbiological response includes: Eradication Absence of causative pathogen from specimens at the site of infection. Presumed eradication where, repeat cultures were not performed/clinically indicated in a patient who had a clinical response of cure.
Time frame: At the end of treatment (EOT) (within 24 hours after last IV dose)
Population: Microbiologically evaluable (ME) analysis set defined as all patients included in the clinically evaluable (CE) set with at least 1 Gram-negative aerobic pathogen in the initial/prestudy culture that was susceptible to both treatment groups.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ceftazidime-Avibactam Plus Metronidazole | The Proportion of Favorable Per-pathogen Microbiological Response at the End of Treatment (EOT) Visit in the Microbiologically Evaluable (ME) Analysis Set. | Escherichia coli (n=69, 77) | 68 Participants with favorable responses |
| Ceftazidime-Avibactam Plus Metronidazole | The Proportion of Favorable Per-pathogen Microbiological Response at the End of Treatment (EOT) Visit in the Microbiologically Evaluable (ME) Analysis Set. | Klebsiella oxytoca (n=5, 5) | 5 Participants with favorable responses |
| Ceftazidime-Avibactam Plus Metronidazole | The Proportion of Favorable Per-pathogen Microbiological Response at the End of Treatment (EOT) Visit in the Microbiologically Evaluable (ME) Analysis Set. | Klebsiella pneumoniae (n=22, 29) | 21 Participants with favorable responses |
| Ceftazidime-Avibactam Plus Metronidazole | The Proportion of Favorable Per-pathogen Microbiological Response at the End of Treatment (EOT) Visit in the Microbiologically Evaluable (ME) Analysis Set. | Pseudomonas aeruginosa (n=14, 16) | 14 Participants with favorable responses |
| Meropenem | The Proportion of Favorable Per-pathogen Microbiological Response at the End of Treatment (EOT) Visit in the Microbiologically Evaluable (ME) Analysis Set. | Pseudomonas aeruginosa (n=14, 16) | 14 Participants with favorable responses |
| Meropenem | The Proportion of Favorable Per-pathogen Microbiological Response at the End of Treatment (EOT) Visit in the Microbiologically Evaluable (ME) Analysis Set. | Escherichia coli (n=69, 77) | 75 Participants with favorable responses |
| Meropenem | The Proportion of Favorable Per-pathogen Microbiological Response at the End of Treatment (EOT) Visit in the Microbiologically Evaluable (ME) Analysis Set. | Klebsiella pneumoniae (n=22, 29) | 28 Participants with favorable responses |
| Meropenem | The Proportion of Favorable Per-pathogen Microbiological Response at the End of Treatment (EOT) Visit in the Microbiologically Evaluable (ME) Analysis Set. | Klebsiella oxytoca (n=5, 5) | 5 Participants with favorable responses |
Secondary
The Proportion of Favorable Per-pathogen Microbiological Response at the End of Treatment (EOT) Visit in the Microbiological Modified Intent-to-treat (mMITT) Analysis Set.
The proportion of patients with a favorable per-pathogen microbiological response: favourable microbiological response includes: Eradication Absence of causative pathogen from specimens at the site of infection. Presumed eradication where, repeat cultures were not performed/clinically indicated in a patient who had a clinical response of cure.
Time frame: At the end of treatment (EOT) (within 24 hours after last IV dose)
Population: The mMITT analysis set included all randomized patients who met the disease definition of cIAI and had at least 1 etiologic pathogen identified at study entry (regardless of isolate susceptibilities). Patients with a bacterial species typically not expected to respond to both study drugs were excluded.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ceftazidime-Avibactam Plus Metronidazole | The Proportion of Favorable Per-pathogen Microbiological Response at the End of Treatment (EOT) Visit in the Microbiological Modified Intent-to-treat (mMITT) Analysis Set. | Streptococcus anginosus grou (n=8, 7) | 7 Participants with favorable responses |
| Ceftazidime-Avibactam Plus Metronidazole | The Proportion of Favorable Per-pathogen Microbiological Response at the End of Treatment (EOT) Visit in the Microbiological Modified Intent-to-treat (mMITT) Analysis Set. | Pseudomonas aeruginosa (n=17, 20) | 15 Participants with favorable responses |
| Ceftazidime-Avibactam Plus Metronidazole | The Proportion of Favorable Per-pathogen Microbiological Response at the End of Treatment (EOT) Visit in the Microbiological Modified Intent-to-treat (mMITT) Analysis Set. | Klebsiella pneumoniae (n=28,35) | 22 Participants with favorable responses |
| Ceftazidime-Avibactam Plus Metronidazole | The Proportion of Favorable Per-pathogen Microbiological Response at the End of Treatment (EOT) Visit in the Microbiological Modified Intent-to-treat (mMITT) Analysis Set. | Enterococcus faecium (n=4, 7) | 4 Participants with favorable responses |
| Ceftazidime-Avibactam Plus Metronidazole | The Proportion of Favorable Per-pathogen Microbiological Response at the End of Treatment (EOT) Visit in the Microbiological Modified Intent-to-treat (mMITT) Analysis Set. | Escherichia coli (n=84, 89) | 77 Participants with favorable responses |
| Ceftazidime-Avibactam Plus Metronidazole | The Proportion of Favorable Per-pathogen Microbiological Response at the End of Treatment (EOT) Visit in the Microbiological Modified Intent-to-treat (mMITT) Analysis Set. | Streptococcus mitis group (n=6, 5) | 6 Participants with favorable responses |
| Ceftazidime-Avibactam Plus Metronidazole | The Proportion of Favorable Per-pathogen Microbiological Response at the End of Treatment (EOT) Visit in the Microbiological Modified Intent-to-treat (mMITT) Analysis Set. | Enterococcus faecalis (n=6, 6) | 5 Participants with favorable responses |
| Ceftazidime-Avibactam Plus Metronidazole | The Proportion of Favorable Per-pathogen Microbiological Response at the End of Treatment (EOT) Visit in the Microbiological Modified Intent-to-treat (mMITT) Analysis Set. | Klebsiella oxytoca (n=5, 5) | 5 Participants with favorable responses |
| Meropenem | The Proportion of Favorable Per-pathogen Microbiological Response at the End of Treatment (EOT) Visit in the Microbiological Modified Intent-to-treat (mMITT) Analysis Set. | Enterococcus faecium (n=4, 7) | 5 Participants with favorable responses |
| Meropenem | The Proportion of Favorable Per-pathogen Microbiological Response at the End of Treatment (EOT) Visit in the Microbiological Modified Intent-to-treat (mMITT) Analysis Set. | Streptococcus anginosus grou (n=8, 7) | 6 Participants with favorable responses |
| Meropenem | The Proportion of Favorable Per-pathogen Microbiological Response at the End of Treatment (EOT) Visit in the Microbiological Modified Intent-to-treat (mMITT) Analysis Set. | Streptococcus mitis group (n=6, 5) | 5 Participants with favorable responses |
| Meropenem | The Proportion of Favorable Per-pathogen Microbiological Response at the End of Treatment (EOT) Visit in the Microbiological Modified Intent-to-treat (mMITT) Analysis Set. | Enterococcus faecalis (n=6, 6) | 5 Participants with favorable responses |
| Meropenem | The Proportion of Favorable Per-pathogen Microbiological Response at the End of Treatment (EOT) Visit in the Microbiological Modified Intent-to-treat (mMITT) Analysis Set. | Escherichia coli (n=84, 89) | 86 Participants with favorable responses |
| Meropenem | The Proportion of Favorable Per-pathogen Microbiological Response at the End of Treatment (EOT) Visit in the Microbiological Modified Intent-to-treat (mMITT) Analysis Set. | Klebsiella oxytoca (n=5, 5) | 5 Participants with favorable responses |
| Meropenem | The Proportion of Favorable Per-pathogen Microbiological Response at the End of Treatment (EOT) Visit in the Microbiological Modified Intent-to-treat (mMITT) Analysis Set. | Klebsiella pneumoniae (n=28,35) | 32 Participants with favorable responses |
| Meropenem | The Proportion of Favorable Per-pathogen Microbiological Response at the End of Treatment (EOT) Visit in the Microbiological Modified Intent-to-treat (mMITT) Analysis Set. | Pseudomonas aeruginosa (n=17, 20) | 17 Participants with favorable responses |
Secondary
The Proportion of Favorable Per-pathogen Microbiological Response at the Late Follow up (LFU) Visit in the Extended Microbiologically Evaluable (ME) Analysis Set.
The proportion of patients with a favorable per-pathogen microbiological response: favourable microbiological response includes: Eradication Absence of causative pathogen from specimens at the site of infection. Presumed eradication where, repeat cultures were not performed/clinically indicated in a patient who had a clinical response of cure.
Time frame: At the late follow up (LFU) (Day 42 to 49)
Population: Extended microbiologically evaluable(ME) analysis set defined as all patients included in the clinically evaluable (CE) set with at least 1 Gram-negative aerobic pathogen in the initial/prestudy culture regardless of susceptibility.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ceftazidime-Avibactam Plus Metronidazole | The Proportion of Favorable Per-pathogen Microbiological Response at the Late Follow up (LFU) Visit in the Extended Microbiologically Evaluable (ME) Analysis Set. | Klebsiella oxytoca (n=5, 5) | 4 Participants with favorable responses |
| Ceftazidime-Avibactam Plus Metronidazole | The Proportion of Favorable Per-pathogen Microbiological Response at the Late Follow up (LFU) Visit in the Extended Microbiologically Evaluable (ME) Analysis Set. | Escherichia coli (n=70, 80) | 64 Participants with favorable responses |
| Ceftazidime-Avibactam Plus Metronidazole | The Proportion of Favorable Per-pathogen Microbiological Response at the Late Follow up (LFU) Visit in the Extended Microbiologically Evaluable (ME) Analysis Set. | Klebsiella pneumoniae (n=22, 30) | 21 Participants with favorable responses |
| Ceftazidime-Avibactam Plus Metronidazole | The Proportion of Favorable Per-pathogen Microbiological Response at the Late Follow up (LFU) Visit in the Extended Microbiologically Evaluable (ME) Analysis Set. | Pseudomonas aeruginosa (n=14, 18) | 13 Participants with favorable responses |
| Meropenem | The Proportion of Favorable Per-pathogen Microbiological Response at the Late Follow up (LFU) Visit in the Extended Microbiologically Evaluable (ME) Analysis Set. | Pseudomonas aeruginosa (n=14, 18) | 16 Participants with favorable responses |
| Meropenem | The Proportion of Favorable Per-pathogen Microbiological Response at the Late Follow up (LFU) Visit in the Extended Microbiologically Evaluable (ME) Analysis Set. | Escherichia coli (n=70, 80) | 75 Participants with favorable responses |
| Meropenem | The Proportion of Favorable Per-pathogen Microbiological Response at the Late Follow up (LFU) Visit in the Extended Microbiologically Evaluable (ME) Analysis Set. | Klebsiella oxytoca (n=5, 5) | 5 Participants with favorable responses |
| Meropenem | The Proportion of Favorable Per-pathogen Microbiological Response at the Late Follow up (LFU) Visit in the Extended Microbiologically Evaluable (ME) Analysis Set. | Klebsiella pneumoniae (n=22, 30) | 28 Participants with favorable responses |
Secondary
The Proportion of Favorable Per-pathogen Microbiological Response at the Late Follow up (LFU) Visit in the Microbiologically Evaluable (ME) Analysis Set.
The proportion of patients with a favorable per-pathogen microbiological response: favourable microbiological response includes: Eradication Absence of causative pathogen from specimens at the site of infection. Presumed eradication where, repeat cultures were not performed/clinically indicated in a patient who had a clinical response of cure.
Time frame: At the late follow up (LFU) (Day 42 to 49)
Population: Microbiologically evaluable (ME) analysis set defined as all patients included in the clinically evaluable (CE) set with at least 1 Gram-negative aerobic pathogen in the initial/prestudy culture that was susceptible to both treatment groups.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ceftazidime-Avibactam Plus Metronidazole | The Proportion of Favorable Per-pathogen Microbiological Response at the Late Follow up (LFU) Visit in the Microbiologically Evaluable (ME) Analysis Set. | Klebsiella pneumoniae (n=22, 29) | 21 Participants with favorable responses |
| Ceftazidime-Avibactam Plus Metronidazole | The Proportion of Favorable Per-pathogen Microbiological Response at the Late Follow up (LFU) Visit in the Microbiologically Evaluable (ME) Analysis Set. | Escherichia coli (n=69, 77) | 63 Participants with favorable responses |
| Ceftazidime-Avibactam Plus Metronidazole | The Proportion of Favorable Per-pathogen Microbiological Response at the Late Follow up (LFU) Visit in the Microbiologically Evaluable (ME) Analysis Set. | Pseudomonas aeruginosa (n=14, 16) | 13 Participants with favorable responses |
| Ceftazidime-Avibactam Plus Metronidazole | The Proportion of Favorable Per-pathogen Microbiological Response at the Late Follow up (LFU) Visit in the Microbiologically Evaluable (ME) Analysis Set. | Klebsiella oxytoca (n=5, 5) | 4 Participants with favorable responses |
| Meropenem | The Proportion of Favorable Per-pathogen Microbiological Response at the Late Follow up (LFU) Visit in the Microbiologically Evaluable (ME) Analysis Set. | Pseudomonas aeruginosa (n=14, 16) | 14 Participants with favorable responses |
| Meropenem | The Proportion of Favorable Per-pathogen Microbiological Response at the Late Follow up (LFU) Visit in the Microbiologically Evaluable (ME) Analysis Set. | Klebsiella pneumoniae (n=22, 29) | 27 Participants with favorable responses |
| Meropenem | The Proportion of Favorable Per-pathogen Microbiological Response at the Late Follow up (LFU) Visit in the Microbiologically Evaluable (ME) Analysis Set. | Escherichia coli (n=69, 77) | 72 Participants with favorable responses |
| Meropenem | The Proportion of Favorable Per-pathogen Microbiological Response at the Late Follow up (LFU) Visit in the Microbiologically Evaluable (ME) Analysis Set. | Klebsiella oxytoca (n=5, 5) | 5 Participants with favorable responses |
Secondary
The Proportion of Favorable Per-pathogen Microbiological Response at the Test of Cure (TOC) Visit in the Extended Microbiologically Evaluable(ME) Analysis Set.
The proportion of patients with a favorable per-pathogen microbiological response: favourable microbiological response includes: Eradication Absence of causative pathogen from specimens at the site of infection. Presumed eradication where, repeat cultures were not performed/clinically indicated in a patient who had a clinical response of cure.
Time frame: At the test of cure (TOC) (Day 28 to 35)
Population: Extended microbiologically evaluable(ME) analysis set defined as all patients included in the clinically evaluable (CE) set with at least 1 Gram-negative aerobic pathogen in the initial/prestudy culture regardless of susceptibility.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ceftazidime-Avibactam Plus Metronidazole | The Proportion of Favorable Per-pathogen Microbiological Response at the Test of Cure (TOC) Visit in the Extended Microbiologically Evaluable(ME) Analysis Set. | Klebsiella oxytoca (n=5, 5) | 5 Participants with favorable responses |
| Ceftazidime-Avibactam Plus Metronidazole | The Proportion of Favorable Per-pathogen Microbiological Response at the Test of Cure (TOC) Visit in the Extended Microbiologically Evaluable(ME) Analysis Set. | Pseudomonas aeruginosa (n=14, 18) | 13 Participants with favorable responses |
| Ceftazidime-Avibactam Plus Metronidazole | The Proportion of Favorable Per-pathogen Microbiological Response at the Test of Cure (TOC) Visit in the Extended Microbiologically Evaluable(ME) Analysis Set. | Escherichia coli (n=70, 80) | 65 Participants with favorable responses |
| Ceftazidime-Avibactam Plus Metronidazole | The Proportion of Favorable Per-pathogen Microbiological Response at the Test of Cure (TOC) Visit in the Extended Microbiologically Evaluable(ME) Analysis Set. | Klebsiella pneumoniae (n=22, 30) | 21 Participants with favorable responses |
| Meropenem | The Proportion of Favorable Per-pathogen Microbiological Response at the Test of Cure (TOC) Visit in the Extended Microbiologically Evaluable(ME) Analysis Set. | Pseudomonas aeruginosa (n=14, 18) | 16 Participants with favorable responses |
| Meropenem | The Proportion of Favorable Per-pathogen Microbiological Response at the Test of Cure (TOC) Visit in the Extended Microbiologically Evaluable(ME) Analysis Set. | Klebsiella oxytoca (n=5, 5) | 5 Participants with favorable responses |
| Meropenem | The Proportion of Favorable Per-pathogen Microbiological Response at the Test of Cure (TOC) Visit in the Extended Microbiologically Evaluable(ME) Analysis Set. | Klebsiella pneumoniae (n=22, 30) | 29 Participants with favorable responses |
| Meropenem | The Proportion of Favorable Per-pathogen Microbiological Response at the Test of Cure (TOC) Visit in the Extended Microbiologically Evaluable(ME) Analysis Set. | Escherichia coli (n=70, 80) | 77 Participants with favorable responses |
Secondary
The Proportion of Favorable Per-pathogen Microbiological Response at the Test of Cure (TOC) Visit in the Microbiologically Evaluable (ME) Analysis Set.
The proportion of patients with a favorable per-pathogen microbiological response: favourable microbiological response includes: Eradication Absence of causative pathogen from specimens at the site of infection. Presumed eradication where, repeat cultures were not performed/clinically indicated in a patient who had a clinical response of cure.
Time frame: At the test of cure (TOC) (Day 28 to 35)
Population: Microbiologically evaluable (ME) analysis set defined as all patients included in the clinically evaluable (CE) set with at least 1 Gram-negative aerobic pathogen in the initial/prestudy culture that was susceptible to both treatment groups.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ceftazidime-Avibactam Plus Metronidazole | The Proportion of Favorable Per-pathogen Microbiological Response at the Test of Cure (TOC) Visit in the Microbiologically Evaluable (ME) Analysis Set. | Klebsiella oxytoca (n=5, 5) | 5 Participants with favorable responses |
| Ceftazidime-Avibactam Plus Metronidazole | The Proportion of Favorable Per-pathogen Microbiological Response at the Test of Cure (TOC) Visit in the Microbiologically Evaluable (ME) Analysis Set. | Pseudomonas aeruginosa (n=14, 16) | 13 Participants with favorable responses |
| Ceftazidime-Avibactam Plus Metronidazole | The Proportion of Favorable Per-pathogen Microbiological Response at the Test of Cure (TOC) Visit in the Microbiologically Evaluable (ME) Analysis Set. | Klebsiella pneumoniae (n=22, 29) | 21 Participants with favorable responses |
| Ceftazidime-Avibactam Plus Metronidazole | The Proportion of Favorable Per-pathogen Microbiological Response at the Test of Cure (TOC) Visit in the Microbiologically Evaluable (ME) Analysis Set. | Escherichia coli (n=69, 77) | 64 Participants with favorable responses |
| Meropenem | The Proportion of Favorable Per-pathogen Microbiological Response at the Test of Cure (TOC) Visit in the Microbiologically Evaluable (ME) Analysis Set. | Klebsiella pneumoniae (n=22, 29) | 28 Participants with favorable responses |
| Meropenem | The Proportion of Favorable Per-pathogen Microbiological Response at the Test of Cure (TOC) Visit in the Microbiologically Evaluable (ME) Analysis Set. | Pseudomonas aeruginosa (n=14, 16) | 14 Participants with favorable responses |
| Meropenem | The Proportion of Favorable Per-pathogen Microbiological Response at the Test of Cure (TOC) Visit in the Microbiologically Evaluable (ME) Analysis Set. | Klebsiella oxytoca (n=5, 5) | 5 Participants with favorable responses |
| Meropenem | The Proportion of Favorable Per-pathogen Microbiological Response at the Test of Cure (TOC) Visit in the Microbiologically Evaluable (ME) Analysis Set. | Escherichia coli (n=69, 77) | 74 Participants with favorable responses |
Secondary
The Proportion of Favorable Per-pathogen Microbiological Response in the Microbiological Response at the Late Follow up (LFU) Visit in the Microbiological Modified Intent-to-treat (mMITT) Analysis Set.
The proportion of patients with a favorable per-pathogen microbiological response: favourable microbiological response includes: Eradication Absence of causative pathogen from specimens at the site of infection. Presumed eradication where, repeat cultures were not performed/clinically indicated in a patient who had a clinical response of cure.
Time frame: At the late follow up (LFU) (Day 42 to 49)
Population: The mMITT analysis set included all randomized patients who met the disease definition of cIAI and had at least 1 etiologic pathogen identified at study entry (regardless of isolate susceptibilities). Patients with a bacterial species typically not expected to respond to both study drugs were excluded.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ceftazidime-Avibactam Plus Metronidazole | The Proportion of Favorable Per-pathogen Microbiological Response in the Microbiological Response at the Late Follow up (LFU) Visit in the Microbiological Modified Intent-to-treat (mMITT) Analysis Set. | Enterococcus faecium (n=4, 7) | 3 Participants with favorable responses |
| Ceftazidime-Avibactam Plus Metronidazole | The Proportion of Favorable Per-pathogen Microbiological Response in the Microbiological Response at the Late Follow up (LFU) Visit in the Microbiological Modified Intent-to-treat (mMITT) Analysis Set. | Streptococcus mitis group (n=6, 5) | 6 Participants with favorable responses |
| Ceftazidime-Avibactam Plus Metronidazole | The Proportion of Favorable Per-pathogen Microbiological Response in the Microbiological Response at the Late Follow up (LFU) Visit in the Microbiological Modified Intent-to-treat (mMITT) Analysis Set. | Escherichia coli (n=84, 89) | 70 Participants with favorable responses |
| Ceftazidime-Avibactam Plus Metronidazole | The Proportion of Favorable Per-pathogen Microbiological Response in the Microbiological Response at the Late Follow up (LFU) Visit in the Microbiological Modified Intent-to-treat (mMITT) Analysis Set. | Klebsiella pneumoniae (n=28, 35) | 22 Participants with favorable responses |
| Ceftazidime-Avibactam Plus Metronidazole | The Proportion of Favorable Per-pathogen Microbiological Response in the Microbiological Response at the Late Follow up (LFU) Visit in the Microbiological Modified Intent-to-treat (mMITT) Analysis Set. | Pseudomonas aeruginosa (n=17, 20) | 14 Participants with favorable responses |
| Ceftazidime-Avibactam Plus Metronidazole | The Proportion of Favorable Per-pathogen Microbiological Response in the Microbiological Response at the Late Follow up (LFU) Visit in the Microbiological Modified Intent-to-treat (mMITT) Analysis Set. | Klebsiella oxytoca (n=5, 5) | 4 Participants with favorable responses |
| Ceftazidime-Avibactam Plus Metronidazole | The Proportion of Favorable Per-pathogen Microbiological Response in the Microbiological Response at the Late Follow up (LFU) Visit in the Microbiological Modified Intent-to-treat (mMITT) Analysis Set. | Enterococcus faecalis (n=6, 6) | 4 Participants with favorable responses |
| Ceftazidime-Avibactam Plus Metronidazole | The Proportion of Favorable Per-pathogen Microbiological Response in the Microbiological Response at the Late Follow up (LFU) Visit in the Microbiological Modified Intent-to-treat (mMITT) Analysis Set. | Streptococcus anginosus group (n=8, 7) | 7 Participants with favorable responses |
| Meropenem | The Proportion of Favorable Per-pathogen Microbiological Response in the Microbiological Response at the Late Follow up (LFU) Visit in the Microbiological Modified Intent-to-treat (mMITT) Analysis Set. | Klebsiella pneumoniae (n=28, 35) | 31 Participants with favorable responses |
| Meropenem | The Proportion of Favorable Per-pathogen Microbiological Response in the Microbiological Response at the Late Follow up (LFU) Visit in the Microbiological Modified Intent-to-treat (mMITT) Analysis Set. | Enterococcus faecium (n=4, 7) | 5 Participants with favorable responses |
| Meropenem | The Proportion of Favorable Per-pathogen Microbiological Response in the Microbiological Response at the Late Follow up (LFU) Visit in the Microbiological Modified Intent-to-treat (mMITT) Analysis Set. | Streptococcus anginosus group (n=8, 7) | 5 Participants with favorable responses |
| Meropenem | The Proportion of Favorable Per-pathogen Microbiological Response in the Microbiological Response at the Late Follow up (LFU) Visit in the Microbiological Modified Intent-to-treat (mMITT) Analysis Set. | Klebsiella oxytoca (n=5, 5) | 5 Participants with favorable responses |
| Meropenem | The Proportion of Favorable Per-pathogen Microbiological Response in the Microbiological Response at the Late Follow up (LFU) Visit in the Microbiological Modified Intent-to-treat (mMITT) Analysis Set. | Streptococcus mitis group (n=6, 5) | 5 Participants with favorable responses |
| Meropenem | The Proportion of Favorable Per-pathogen Microbiological Response in the Microbiological Response at the Late Follow up (LFU) Visit in the Microbiological Modified Intent-to-treat (mMITT) Analysis Set. | Pseudomonas aeruginosa (n=17, 20) | 17 Participants with favorable responses |
| Meropenem | The Proportion of Favorable Per-pathogen Microbiological Response in the Microbiological Response at the Late Follow up (LFU) Visit in the Microbiological Modified Intent-to-treat (mMITT) Analysis Set. | Escherichia coli (n=84, 89) | 82 Participants with favorable responses |
| Meropenem | The Proportion of Favorable Per-pathogen Microbiological Response in the Microbiological Response at the Late Follow up (LFU) Visit in the Microbiological Modified Intent-to-treat (mMITT) Analysis Set. | Enterococcus faecalis (n=6, 6) | 4 Participants with favorable responses |
Secondary
The Proportion of Favorable Per-pathogen Microbiological Response in the Microbiological Response at the Test of Cure (TOC) Visit in the Microbiological Modified Intent-to-treat (mMITT) Analysis Set.
The proportion of patients with a favorable per-pathogen microbiological response: favourable microbiological response includes: Eradication Absence of causative pathogen from specimens at the site of infection. Presumed eradication where, repeat cultures were not performed/clinically indicated in a patient who had a clinical response of cure.
Time frame: At the test of cure (TOC) (Day 28 to 35)
Population: The mMITT analysis set included all randomized patients who met the disease definition of cIAI and had at least 1 etiologic pathogen identified at study entry (regardless of isolate susceptibilities). Patients with a bacterial species typically not expected to respond to both study drugs were excluded.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ceftazidime-Avibactam Plus Metronidazole | The Proportion of Favorable Per-pathogen Microbiological Response in the Microbiological Response at the Test of Cure (TOC) Visit in the Microbiological Modified Intent-to-treat (mMITT) Analysis Set. | Escherichia coli (n=84, 89) | 70 Participants with favorable responses |
| Ceftazidime-Avibactam Plus Metronidazole | The Proportion of Favorable Per-pathogen Microbiological Response in the Microbiological Response at the Test of Cure (TOC) Visit in the Microbiological Modified Intent-to-treat (mMITT) Analysis Set. | Klebsiella oxytoca (n=5, 5) | 5 Participants with favorable responses |
| Ceftazidime-Avibactam Plus Metronidazole | The Proportion of Favorable Per-pathogen Microbiological Response in the Microbiological Response at the Test of Cure (TOC) Visit in the Microbiological Modified Intent-to-treat (mMITT) Analysis Set. | Pseudomonas aeruginosa (n=17, 20) | 14 Participants with favorable responses |
| Ceftazidime-Avibactam Plus Metronidazole | The Proportion of Favorable Per-pathogen Microbiological Response in the Microbiological Response at the Test of Cure (TOC) Visit in the Microbiological Modified Intent-to-treat (mMITT) Analysis Set. | Streptococcus anginosus group (n=8, 7) | 7 Participants with favorable responses |
| Ceftazidime-Avibactam Plus Metronidazole | The Proportion of Favorable Per-pathogen Microbiological Response in the Microbiological Response at the Test of Cure (TOC) Visit in the Microbiological Modified Intent-to-treat (mMITT) Analysis Set. | Klebsiella pneumoniae (n=28,35) | 23 Participants with favorable responses |
| Ceftazidime-Avibactam Plus Metronidazole | The Proportion of Favorable Per-pathogen Microbiological Response in the Microbiological Response at the Test of Cure (TOC) Visit in the Microbiological Modified Intent-to-treat (mMITT) Analysis Set. | Streptococcus mitis group (n=6, 5) | 6 Participants with favorable responses |
| Ceftazidime-Avibactam Plus Metronidazole | The Proportion of Favorable Per-pathogen Microbiological Response in the Microbiological Response at the Test of Cure (TOC) Visit in the Microbiological Modified Intent-to-treat (mMITT) Analysis Set. | Enterococcus faecalis (n=6, 6) | 6 Participants with favorable responses |
| Ceftazidime-Avibactam Plus Metronidazole | The Proportion of Favorable Per-pathogen Microbiological Response in the Microbiological Response at the Test of Cure (TOC) Visit in the Microbiological Modified Intent-to-treat (mMITT) Analysis Set. | Enterococcus faecium (n=4, 7) | 4 Participants with favorable responses |
| Meropenem | The Proportion of Favorable Per-pathogen Microbiological Response in the Microbiological Response at the Test of Cure (TOC) Visit in the Microbiological Modified Intent-to-treat (mMITT) Analysis Set. | Enterococcus faecium (n=4, 7) | 5 Participants with favorable responses |
| Meropenem | The Proportion of Favorable Per-pathogen Microbiological Response in the Microbiological Response at the Test of Cure (TOC) Visit in the Microbiological Modified Intent-to-treat (mMITT) Analysis Set. | Escherichia coli (n=84, 89) | 84 Participants with favorable responses |
| Meropenem | The Proportion of Favorable Per-pathogen Microbiological Response in the Microbiological Response at the Test of Cure (TOC) Visit in the Microbiological Modified Intent-to-treat (mMITT) Analysis Set. | Streptococcus anginosus group (n=8, 7) | 5 Participants with favorable responses |
| Meropenem | The Proportion of Favorable Per-pathogen Microbiological Response in the Microbiological Response at the Test of Cure (TOC) Visit in the Microbiological Modified Intent-to-treat (mMITT) Analysis Set. | Klebsiella pneumoniae (n=28,35) | 31 Participants with favorable responses |
| Meropenem | The Proportion of Favorable Per-pathogen Microbiological Response in the Microbiological Response at the Test of Cure (TOC) Visit in the Microbiological Modified Intent-to-treat (mMITT) Analysis Set. | Enterococcus faecalis (n=6, 6) | 4 Participants with favorable responses |
| Meropenem | The Proportion of Favorable Per-pathogen Microbiological Response in the Microbiological Response at the Test of Cure (TOC) Visit in the Microbiological Modified Intent-to-treat (mMITT) Analysis Set. | Pseudomonas aeruginosa (n=17, 20) | 17 Participants with favorable responses |
| Meropenem | The Proportion of Favorable Per-pathogen Microbiological Response in the Microbiological Response at the Test of Cure (TOC) Visit in the Microbiological Modified Intent-to-treat (mMITT) Analysis Set. | Streptococcus mitis group (n=6, 5) | 5 Participants with favorable responses |
| Meropenem | The Proportion of Favorable Per-pathogen Microbiological Response in the Microbiological Response at the Test of Cure (TOC) Visit in the Microbiological Modified Intent-to-treat (mMITT) Analysis Set. | Klebsiella oxytoca (n=5, 5) | 5 Participants with favorable responses |
Secondary
The Proportion of Patients With a Favorable Per-patient Microbiological Response at the End of Treatment (EOT) Visit in the Extended Microbiologically Evaluable (ME) Analysis Set.
Per-patient favorable response indicates that all of the patient's baseline pathogens are eradicated or presumed eradicated.
Time frame: At the end of treatment (EOT) (within 24 hours after last IV dose)
Population: Extended microbiologically evaluable (ME) analysis set defined as all patients included in the clinically evaluable (CE) set with at least 1 Gram-negative aerobic pathogen in the initial/prestudy culture regardless of susceptibility.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ceftazidime-Avibactam Plus Metronidazole | The Proportion of Patients With a Favorable Per-patient Microbiological Response at the End of Treatment (EOT) Visit in the Extended Microbiologically Evaluable (ME) Analysis Set. | Favorable | 104 Number of patients |
| Ceftazidime-Avibactam Plus Metronidazole | The Proportion of Patients With a Favorable Per-patient Microbiological Response at the End of Treatment (EOT) Visit in the Extended Microbiologically Evaluable (ME) Analysis Set. | Unfavorable | 3 Number of patients |
| Meropenem | The Proportion of Patients With a Favorable Per-patient Microbiological Response at the End of Treatment (EOT) Visit in the Extended Microbiologically Evaluable (ME) Analysis Set. | Favorable | 120 Number of patients |
| Meropenem | The Proportion of Patients With a Favorable Per-patient Microbiological Response at the End of Treatment (EOT) Visit in the Extended Microbiologically Evaluable (ME) Analysis Set. | Unfavorable | 5 Number of patients |
Secondary
The Proportion of Patients With a Favorable Per-patient Microbiological Response at the End of Treatment (EOT) Visit in the Microbiologically Evaluable (ME) Analysis Set.
Per-patient favorable response indicates that all of the patient's baseline pathogens are eradicated or presumed eradicated.
Time frame: At the end of treatment (EOT) (within 24 hours after last IV dose)
Population: Microbiologically evaluable (ME) analysis set defined as all patients included in the clinically evaluable (CE) set with at least 1 Gram-negative aerobic pathogen in the initial/prestudy culture that was susceptible to both treatment groups.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ceftazidime-Avibactam Plus Metronidazole | The Proportion of Patients With a Favorable Per-patient Microbiological Response at the End of Treatment (EOT) Visit in the Microbiologically Evaluable (ME) Analysis Set. | Favorable | 103 Number of patients |
| Ceftazidime-Avibactam Plus Metronidazole | The Proportion of Patients With a Favorable Per-patient Microbiological Response at the End of Treatment (EOT) Visit in the Microbiologically Evaluable (ME) Analysis Set. | Unfavorable | 3 Number of patients |
| Meropenem | The Proportion of Patients With a Favorable Per-patient Microbiological Response at the End of Treatment (EOT) Visit in the Microbiologically Evaluable (ME) Analysis Set. | Favorable | 113 Number of patients |
| Meropenem | The Proportion of Patients With a Favorable Per-patient Microbiological Response at the End of Treatment (EOT) Visit in the Microbiologically Evaluable (ME) Analysis Set. | Unfavorable | 5 Number of patients |
Secondary
The Proportion of Patients With a Favorable Per-patient Microbiological Response at the End of Treatment (EOT) Visit in the Microbiological Modified Intent-to-treat (mMITT) Analysis Set.
Per-patient favorable response indicates that all of the patient's baseline pathogens are eradicated or presumed eradicated.
Time frame: At the end of treatment (EOT) (within 24 hours after last IV dose)
Population: The microbiological modified intent-to-treat (mMITT) analysis set included all randomized patients who met the disease definition of cIAI and had at least 1 etiologic pathogen identified at study entry (regardless of isolate susceptibilities). Patients with a bacterial species typically not expected to respond to both study drugs were excluded.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ceftazidime-Avibactam Plus Metronidazole | The Proportion of Patients With a Favorable Per-patient Microbiological Response at the End of Treatment (EOT) Visit in the Microbiological Modified Intent-to-treat (mMITT) Analysis Set. | Favorable | 126 Number of patients |
| Ceftazidime-Avibactam Plus Metronidazole | The Proportion of Patients With a Favorable Per-patient Microbiological Response at the End of Treatment (EOT) Visit in the Microbiological Modified Intent-to-treat (mMITT) Analysis Set. | Unfavorable | 6 Number of patients |
| Ceftazidime-Avibactam Plus Metronidazole | The Proportion of Patients With a Favorable Per-patient Microbiological Response at the End of Treatment (EOT) Visit in the Microbiological Modified Intent-to-treat (mMITT) Analysis Set. | Indeterminate | 11 Number of patients |
| Meropenem | The Proportion of Patients With a Favorable Per-patient Microbiological Response at the End of Treatment (EOT) Visit in the Microbiological Modified Intent-to-treat (mMITT) Analysis Set. | Favorable | 140 Number of patients |
| Meropenem | The Proportion of Patients With a Favorable Per-patient Microbiological Response at the End of Treatment (EOT) Visit in the Microbiological Modified Intent-to-treat (mMITT) Analysis Set. | Unfavorable | 7 Number of patients |
| Meropenem | The Proportion of Patients With a Favorable Per-patient Microbiological Response at the End of Treatment (EOT) Visit in the Microbiological Modified Intent-to-treat (mMITT) Analysis Set. | Indeterminate | 5 Number of patients |
Secondary
The Proportion of Patients With a Favorable Per-patient Microbiological Response at the Late Follow up (LFU) Visit in the Extended Microbiologically Evaluable (ME) Analysis Set.
Per-patient favorable response indicates that all of the patient's baseline pathogens are eradicated or presumed eradicated.
Time frame: At the late follow up (LFU) (Day 42 to 49)
Population: Extended microbiologically evaluable (ME) analysis set defined as all patients included in the clinically evaluable (CE) set with at least 1 Gram-negative aerobic pathogen in the initial/prestudy culture regardless of susceptibility.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ceftazidime-Avibactam Plus Metronidazole | The Proportion of Patients With a Favorable Per-patient Microbiological Response at the Late Follow up (LFU) Visit in the Extended Microbiologically Evaluable (ME) Analysis Set. | Favorable | 90 Number of patients |
| Ceftazidime-Avibactam Plus Metronidazole | The Proportion of Patients With a Favorable Per-patient Microbiological Response at the Late Follow up (LFU) Visit in the Extended Microbiologically Evaluable (ME) Analysis Set. | Unfavorable | 7 Number of patients |
| Meropenem | The Proportion of Patients With a Favorable Per-patient Microbiological Response at the Late Follow up (LFU) Visit in the Extended Microbiologically Evaluable (ME) Analysis Set. | Favorable | 106 Number of patients |
| Meropenem | The Proportion of Patients With a Favorable Per-patient Microbiological Response at the Late Follow up (LFU) Visit in the Extended Microbiologically Evaluable (ME) Analysis Set. | Unfavorable | 6 Number of patients |
Secondary
The Proportion of Patients With a Favorable Per-patient Microbiological Response at the Late Follow up (LFU) Visit in the Microbiologically Evaluable (ME) Analysis Set.
Per-patient favorable response indicates that all of the patient's baseline pathogens are eradicated or presumed eradicated.
Time frame: At the late follow up (LFU) (Day 42 to 49)
Population: Microbiologically evaluable (ME) analysis set defined as all patients included in the clinically evaluable (CE) set with at least 1 Gram-negative aerobic pathogen in the initial/prestudy culture that was susceptible to both treatment groups.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ceftazidime-Avibactam Plus Metronidazole | The Proportion of Patients With a Favorable Per-patient Microbiological Response at the Late Follow up (LFU) Visit in the Microbiologically Evaluable (ME) Analysis Set. | Favorable | 89 Number of patients |
| Ceftazidime-Avibactam Plus Metronidazole | The Proportion of Patients With a Favorable Per-patient Microbiological Response at the Late Follow up (LFU) Visit in the Microbiologically Evaluable (ME) Analysis Set. | Unfavorable | 7 Number of patients |
| Meropenem | The Proportion of Patients With a Favorable Per-patient Microbiological Response at the Late Follow up (LFU) Visit in the Microbiologically Evaluable (ME) Analysis Set. | Favorable | 100 Number of patients |
| Meropenem | The Proportion of Patients With a Favorable Per-patient Microbiological Response at the Late Follow up (LFU) Visit in the Microbiologically Evaluable (ME) Analysis Set. | Unfavorable | 6 Number of patients |
Secondary
The Proportion of Patients With a Favorable Per-patient Microbiological Response at the Late Follow up (LFU) Visit in the Microbiological Modified Intent-to-treat (mMITT) Analysis Set.
Per-patient favorable response indicates that all of the patient's baseline pathogens are eradicated or presumed eradicated.
Time frame: At the late follow up (LFU) (Day 42 to 49)
Population: The microbiological modified intent-to-treat (mMITT) analysis set included all randomized patients who met the disease definition of cIAI and had at least 1 etiologic pathogen identified at study entry (regardless of isolate susceptibilities). Patients with a bacterial species typically not expected to respond to both study drugs were excluded.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ceftazidime-Avibactam Plus Metronidazole | The Proportion of Patients With a Favorable Per-patient Microbiological Response at the Late Follow up (LFU) Visit in the Microbiological Modified Intent-to-treat (mMITT) Analysis Set. | Favorable | 116 Number of patients |
| Ceftazidime-Avibactam Plus Metronidazole | The Proportion of Patients With a Favorable Per-patient Microbiological Response at the Late Follow up (LFU) Visit in the Microbiological Modified Intent-to-treat (mMITT) Analysis Set. | Unfavorable | 10 Number of patients |
| Ceftazidime-Avibactam Plus Metronidazole | The Proportion of Patients With a Favorable Per-patient Microbiological Response at the Late Follow up (LFU) Visit in the Microbiological Modified Intent-to-treat (mMITT) Analysis Set. | Indeterminate | 17 Number of patients |
| Meropenem | The Proportion of Patients With a Favorable Per-patient Microbiological Response at the Late Follow up (LFU) Visit in the Microbiological Modified Intent-to-treat (mMITT) Analysis Set. | Favorable | 132 Number of patients |
| Meropenem | The Proportion of Patients With a Favorable Per-patient Microbiological Response at the Late Follow up (LFU) Visit in the Microbiological Modified Intent-to-treat (mMITT) Analysis Set. | Unfavorable | 9 Number of patients |
| Meropenem | The Proportion of Patients With a Favorable Per-patient Microbiological Response at the Late Follow up (LFU) Visit in the Microbiological Modified Intent-to-treat (mMITT) Analysis Set. | Indeterminate | 11 Number of patients |
Secondary
The Proportion of Patients With a Favorable Per Patient Microbiological Response at the Test of Cure (TOC) Visit for Patients Infected With Ceftazidime Resistant Pathogens in the Extended Microbiologically Evaluable (ME) Analysis Set.
The microbiological responses as per the protocoled criteria: responses other than indeterminate were classified as favorable or unfavorable. Favorable microbiological response assessments included eradication and presumed eradication. Unfavorable microbiological response assessments included persistence, persistence with increasing minimum inhibitory concentration (MIC), and presumed persistence. Indeterminate microbiologic response assessments included cases where the clinical response was changed to indeterminate due to an SRP assessment of inadequate source control (ie, circumstances that preclude classification as eradication, presumed eradication, persistence, persistence with increasing MIC, and presumed persistence).
Time frame: At the test of cure (TOC) (Day 28 to 35)
Population: Extended microbiologically evaluable(ME) analysis set defined as all patients included in the clinically evaluable (CE) set with at least 1 Gram-negative aerobic pathogen in the initial/prestudy culture regardless of susceptibility.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ceftazidime-Avibactam Plus Metronidazole | The Proportion of Patients With a Favorable Per Patient Microbiological Response at the Test of Cure (TOC) Visit for Patients Infected With Ceftazidime Resistant Pathogens in the Extended Microbiologically Evaluable (ME) Analysis Set. | Favorable | 22 Number of patients |
| Ceftazidime-Avibactam Plus Metronidazole | The Proportion of Patients With a Favorable Per Patient Microbiological Response at the Test of Cure (TOC) Visit for Patients Infected With Ceftazidime Resistant Pathogens in the Extended Microbiologically Evaluable (ME) Analysis Set. | Unfavorable | 1 Number of patients |
| Meropenem | The Proportion of Patients With a Favorable Per Patient Microbiological Response at the Test of Cure (TOC) Visit for Patients Infected With Ceftazidime Resistant Pathogens in the Extended Microbiologically Evaluable (ME) Analysis Set. | Favorable | 25 Number of patients |
| Meropenem | The Proportion of Patients With a Favorable Per Patient Microbiological Response at the Test of Cure (TOC) Visit for Patients Infected With Ceftazidime Resistant Pathogens in the Extended Microbiologically Evaluable (ME) Analysis Set. | Unfavorable | 1 Number of patients |
Secondary
The Proportion of Patients With a Favorable Per Patient Microbiological Response at the Test of Cure (TOC) Visit for Patients Infected With Ceftazidime Resistant Pathogens in the Microbiologically Evaluable (ME) Analysis Set.
The microbiological responses as per the protocoled criteria: responses other than indeterminate were classified as favorable or unfavorable. Favorable microbiological response assessments included eradication and presumed eradication. Unfavorable microbiological response assessments included persistence, persistence with increasing minimum inhibitory concentration (MIC), and presumed persistence. Indeterminate microbiologic response assessments included cases where the clinical response was changed to indeterminate due to an SRP assessment of inadequate source control (ie, circumstances that preclude classification as eradication, presumed eradication, persistence, persistence with increasing MIC, and presumed persistence).
Time frame: At the test of cure (TOC) (Day 28 to 35)
Population: Microbiologically evaluable (ME) analysis set defined as all patients included in the clinically evaluable (CE) set with at least 1 Gram-negative aerobic pathogen in the initial/prestudy culture that was susceptible to both treatment groups.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ceftazidime-Avibactam Plus Metronidazole | The Proportion of Patients With a Favorable Per Patient Microbiological Response at the Test of Cure (TOC) Visit for Patients Infected With Ceftazidime Resistant Pathogens in the Microbiologically Evaluable (ME) Analysis Set. | Unfavorable | 1 Number of patients |
| Ceftazidime-Avibactam Plus Metronidazole | The Proportion of Patients With a Favorable Per Patient Microbiological Response at the Test of Cure (TOC) Visit for Patients Infected With Ceftazidime Resistant Pathogens in the Microbiologically Evaluable (ME) Analysis Set. | Favorable | 22 Number of patients |
| Meropenem | The Proportion of Patients With a Favorable Per Patient Microbiological Response at the Test of Cure (TOC) Visit for Patients Infected With Ceftazidime Resistant Pathogens in the Microbiologically Evaluable (ME) Analysis Set. | Unfavorable | 1 Number of patients |
| Meropenem | The Proportion of Patients With a Favorable Per Patient Microbiological Response at the Test of Cure (TOC) Visit for Patients Infected With Ceftazidime Resistant Pathogens in the Microbiologically Evaluable (ME) Analysis Set. | Favorable | 23 Number of patients |
Secondary
The Proportion of Patients With a Favorable Per Patient Microbiological Response at the Test of Cure (TOC) Visit for Patients Infected With Ceftazidime Resistant Pathogens in the Microbiological Modified Intent-to-treat (mMITT) Analysis Set.
The microbiological responses as per the protocoled criteria: responses other than indeterminate were classified as favorable or unfavorable. Favorable microbiological response assessments included eradication and presumed eradication. Unfavorable microbiological response assessments included persistence, persistence with increasing minimum inhibitory concentration (MIC), and presumed persistence. Indeterminate microbiologic response assessments included cases where the clinical response was changed to indeterminate due to an SRP assessment of inadequate source control (ie, circumstances that preclude classification as eradication, presumed eradication, persistence, persistence with increasing MIC, and presumed persistence).
Time frame: At the test of cure (TOC) (Day 28 to 35)
Population: The microbiological modified intent-to-treat (mMITT) analysis set included all randomized patients who met the disease definition of cIAI and had at least 1 etiologic pathogen identified at study entry (regardless of isolate susceptibilities). Patients with a bacterial species typically not expected to respond to both study drugs were excluded.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ceftazidime-Avibactam Plus Metronidazole | The Proportion of Patients With a Favorable Per Patient Microbiological Response at the Test of Cure (TOC) Visit for Patients Infected With Ceftazidime Resistant Pathogens in the Microbiological Modified Intent-to-treat (mMITT) Analysis Set. | Unfavorable | 1 Number of patients |
| Ceftazidime-Avibactam Plus Metronidazole | The Proportion of Patients With a Favorable Per Patient Microbiological Response at the Test of Cure (TOC) Visit for Patients Infected With Ceftazidime Resistant Pathogens in the Microbiological Modified Intent-to-treat (mMITT) Analysis Set. | Favorable | 24 Number of patients |
| Ceftazidime-Avibactam Plus Metronidazole | The Proportion of Patients With a Favorable Per Patient Microbiological Response at the Test of Cure (TOC) Visit for Patients Infected With Ceftazidime Resistant Pathogens in the Microbiological Modified Intent-to-treat (mMITT) Analysis Set. | Indeterminate | 4 Number of patients |
| Meropenem | The Proportion of Patients With a Favorable Per Patient Microbiological Response at the Test of Cure (TOC) Visit for Patients Infected With Ceftazidime Resistant Pathogens in the Microbiological Modified Intent-to-treat (mMITT) Analysis Set. | Favorable | 27 Number of patients |
| Meropenem | The Proportion of Patients With a Favorable Per Patient Microbiological Response at the Test of Cure (TOC) Visit for Patients Infected With Ceftazidime Resistant Pathogens in the Microbiological Modified Intent-to-treat (mMITT) Analysis Set. | Unfavorable | 1 Number of patients |
| Meropenem | The Proportion of Patients With a Favorable Per Patient Microbiological Response at the Test of Cure (TOC) Visit for Patients Infected With Ceftazidime Resistant Pathogens in the Microbiological Modified Intent-to-treat (mMITT) Analysis Set. | Indeterminate | 1 Number of patients |
Secondary
The Proportion of Patients With a Favorable Per-patient Microbiological Response at the Test of Cure (TOC) Visit in the Extended Microbiologically Evaluable (ME) Analysis Set.
Per-patient favorable response indicates that all of the patient's baseline pathogens are eradicated or presumed eradicated.
Time frame: At the test of cure (TOC) (Day 28 to 35)
Population: Extended microbiologically evaluable (ME) analysis set defined as all patients included in the clinically evaluable (CE) set with at least 1 Gram-negative aerobic pathogen in the initial/prestudy culture regardless of susceptibility.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ceftazidime-Avibactam Plus Metronidazole | The Proportion of Patients With a Favorable Per-patient Microbiological Response at the Test of Cure (TOC) Visit in the Extended Microbiologically Evaluable (ME) Analysis Set. | Favorable | 93 Number of patients |
| Ceftazidime-Avibactam Plus Metronidazole | The Proportion of Patients With a Favorable Per-patient Microbiological Response at the Test of Cure (TOC) Visit in the Extended Microbiologically Evaluable (ME) Analysis Set. | Unfavorable | 7 Number of patients |
| Meropenem | The Proportion of Patients With a Favorable Per-patient Microbiological Response at the Test of Cure (TOC) Visit in the Extended Microbiologically Evaluable (ME) Analysis Set. | Favorable | 113 Number of patients |
| Meropenem | The Proportion of Patients With a Favorable Per-patient Microbiological Response at the Test of Cure (TOC) Visit in the Extended Microbiologically Evaluable (ME) Analysis Set. | Unfavorable | 6 Number of patients |
Secondary
The Proportion of Patients With a Favorable Per-patient Microbiological Response at the Test of Cure (TOC) Visit in the Microbiologically Evaluable (ME) Analysis Set.
Per-patient favorable response indicates that all of the patient's baseline pathogens are eradicated or presumed eradicated.
Time frame: At the test of cure (TOC) (Day 28 to 35)
Population: Microbiologically evaluable (ME) analysis set defined as all patients included in the clinically evaluable (CE) set with at least 1 Gram-negative aerobic pathogen in the initial/prestudy culture that was susceptible to both treatment groups.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ceftazidime-Avibactam Plus Metronidazole | The Proportion of Patients With a Favorable Per-patient Microbiological Response at the Test of Cure (TOC) Visit in the Microbiologically Evaluable (ME) Analysis Set. | Favorable | 92 Number of patients |
| Ceftazidime-Avibactam Plus Metronidazole | The Proportion of Patients With a Favorable Per-patient Microbiological Response at the Test of Cure (TOC) Visit in the Microbiologically Evaluable (ME) Analysis Set. | Unfavorable | 7 Number of patients |
| Meropenem | The Proportion of Patients With a Favorable Per-patient Microbiological Response at the Test of Cure (TOC) Visit in the Microbiologically Evaluable (ME) Analysis Set. | Favorable | 107 Number of patients |
| Meropenem | The Proportion of Patients With a Favorable Per-patient Microbiological Response at the Test of Cure (TOC) Visit in the Microbiologically Evaluable (ME) Analysis Set. | Unfavorable | 6 Number of patients |
Secondary
The Proportion of Patients With a Favorable Per-patient Microbiological Response at the Test of Cure (TOC) Visit in the Microbiological Modified Intent-to-treat (mMITT) Analysis Set.
Per-patient favorable response indicates that all of the patient's baseline pathogens are eradicated or presumed eradicated.
Time frame: At the test of cure (TOC) (Day 28 to 35)
Population: The microbiological modified intent-to-treat (mMITT) analysis set included all randomized patients who met the disease definition of cIAI and had at least 1 etiologic pathogen identified at study entry (regardless of isolate susceptibilities). Patients with a bacterial species typically not expected to respond to both study drugs were excluded.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ceftazidime-Avibactam Plus Metronidazole | The Proportion of Patients With a Favorable Per-patient Microbiological Response at the Test of Cure (TOC) Visit in the Microbiological Modified Intent-to-treat (mMITT) Analysis Set. | Favorable | 119 Number of patients |
| Ceftazidime-Avibactam Plus Metronidazole | The Proportion of Patients With a Favorable Per-patient Microbiological Response at the Test of Cure (TOC) Visit in the Microbiological Modified Intent-to-treat (mMITT) Analysis Set. | Unfavorable | 10 Number of patients |
| Ceftazidime-Avibactam Plus Metronidazole | The Proportion of Patients With a Favorable Per-patient Microbiological Response at the Test of Cure (TOC) Visit in the Microbiological Modified Intent-to-treat (mMITT) Analysis Set. | Indeterminate | 14 Number of patients |
| Meropenem | The Proportion of Patients With a Favorable Per-patient Microbiological Response at the Test of Cure (TOC) Visit in the Microbiological Modified Intent-to-treat (mMITT) Analysis Set. | Favorable | 135 Number of patients |
| Meropenem | The Proportion of Patients With a Favorable Per-patient Microbiological Response at the Test of Cure (TOC) Visit in the Microbiological Modified Intent-to-treat (mMITT) Analysis Set. | Unfavorable | 9 Number of patients |
| Meropenem | The Proportion of Patients With a Favorable Per-patient Microbiological Response at the Test of Cure (TOC) Visit in the Microbiological Modified Intent-to-treat (mMITT) Analysis Set. | Indeterminate | 8 Number of patients |
Secondary
The Proportion of Patients With Clinical Cure at the End of Treatment (EOT) Visit in the Clinically Evaluable (CE) Analysis Set.
The proportion of patients meeting the cure criteria: complete resolution or significant improvement of signs and symptoms of the index infection such that no further antibacterial therapy, drainage, or surgical intervention was necessary.
Time frame: At the end of treatment (EOT) (within 24 hours after last IV dose)
Population: The clinically evaluable (CE) analysis set included all patients who met the disease definition of cIAI and met the stringent criteria for clinical evaluation described in the protocol regarding dosing, concomitant medication, evaluation, etc.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ceftazidime-Avibactam Plus Metronidazole | The Proportion of Patients With Clinical Cure at the End of Treatment (EOT) Visit in the Clinically Evaluable (CE) Analysis Set. | Clinical cure | 183 Number of patients |
| Ceftazidime-Avibactam Plus Metronidazole | The Proportion of Patients With Clinical Cure at the End of Treatment (EOT) Visit in the Clinically Evaluable (CE) Analysis Set. | Clinical failure | 7 Number of patients |
| Meropenem | The Proportion of Patients With Clinical Cure at the End of Treatment (EOT) Visit in the Clinically Evaluable (CE) Analysis Set. | Clinical cure | 187 Number of patients |
| Meropenem | The Proportion of Patients With Clinical Cure at the End of Treatment (EOT) Visit in the Clinically Evaluable (CE) Analysis Set. | Clinical failure | 9 Number of patients |
Secondary
The Proportion of Patients With Clinical Cure at the End of Treatment (EOT) Visit in the Extended Microbiologically Evaluable (ME) Analysis Set.
The proportion of patients meeting the cure criteria: complete resolution or significant improvement of signs and symptoms of the index infection such that no further antibacterial therapy, drainage, or surgical intervention was necessary.
Time frame: At the end of treatment (EOT) (within 24 hours after last IV dose)
Population: Extended microbiologically evaluable (ME) analysis set defined as all patients included in the clinically evaluable (CE) set with at least 1 Gram-negative aerobic pathogen in the initial/prestudy culture regardless of susceptibility.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ceftazidime-Avibactam Plus Metronidazole | The Proportion of Patients With Clinical Cure at the End of Treatment (EOT) Visit in the Extended Microbiologically Evaluable (ME) Analysis Set. | Clinical cure | 104 Number of patients |
| Ceftazidime-Avibactam Plus Metronidazole | The Proportion of Patients With Clinical Cure at the End of Treatment (EOT) Visit in the Extended Microbiologically Evaluable (ME) Analysis Set. | Clinical failure | 3 Number of patients |
| Meropenem | The Proportion of Patients With Clinical Cure at the End of Treatment (EOT) Visit in the Extended Microbiologically Evaluable (ME) Analysis Set. | Clinical cure | 120 Number of patients |
| Meropenem | The Proportion of Patients With Clinical Cure at the End of Treatment (EOT) Visit in the Extended Microbiologically Evaluable (ME) Analysis Set. | Clinical failure | 5 Number of patients |
Secondary
The Proportion of Patients With Clinical Cure at the End of Treatment (EOT) Visit in the Microbiologically Evaluable (ME) Analysis Set.
The proportion of patients meeting the cure criteria: complete resolution or significant improvement of signs and symptoms of the index infection such that no further antibacterial therapy, drainage, or surgical intervention was necessary.
Time frame: At the end of treatment (EOT) (within 24 hours after last IV dose)
Population: Microbiologically evaluable (ME) analysis set defined as all patients included in the clinically evaluable (CE) set with at least 1 Gram-negative aerobic pathogen in the initial/prestudy culture that was susceptible to both treatment groups.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ceftazidime-Avibactam Plus Metronidazole | The Proportion of Patients With Clinical Cure at the End of Treatment (EOT) Visit in the Microbiologically Evaluable (ME) Analysis Set. | Clinical cure | 103 Number of patients |
| Ceftazidime-Avibactam Plus Metronidazole | The Proportion of Patients With Clinical Cure at the End of Treatment (EOT) Visit in the Microbiologically Evaluable (ME) Analysis Set. | Clinical failure | 3 Number of patients |
| Meropenem | The Proportion of Patients With Clinical Cure at the End of Treatment (EOT) Visit in the Microbiologically Evaluable (ME) Analysis Set. | Clinical cure | 113 Number of patients |
| Meropenem | The Proportion of Patients With Clinical Cure at the End of Treatment (EOT) Visit in the Microbiologically Evaluable (ME) Analysis Set. | Clinical failure | 5 Number of patients |
Secondary
The Proportion of Patients With Clinical Cure at the End of Treatment (EOT) Visit in the Microbiological Modified Intent-to-treat (mMITT) Analysis Set.
The proportion of patients meeting the cure criteria: complete resolution or significant improvement of signs and symptoms of the index infection such that no further antibacterial therapy, drainage, or surgical intervention was necessary.
Time frame: At the end of treatment (EOT) (within 24 hours after last IV dose)
Population: The microbiological modified intent-to-treat mMITT analysis set included all randomized patients who met the disease definition of cIAI and had at least 1 etiologic pathogen identified at study entry (regardless of isolate susceptibilities). Patients with a bacterial species typically not expected to respond to both study drugs were excluded.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ceftazidime-Avibactam Plus Metronidazole | The Proportion of Patients With Clinical Cure at the End of Treatment (EOT) Visit in the Microbiological Modified Intent-to-treat (mMITT) Analysis Set. | Clinical cure | 126 Number of patients |
| Ceftazidime-Avibactam Plus Metronidazole | The Proportion of Patients With Clinical Cure at the End of Treatment (EOT) Visit in the Microbiological Modified Intent-to-treat (mMITT) Analysis Set. | Clinical failure | 6 Number of patients |
| Ceftazidime-Avibactam Plus Metronidazole | The Proportion of Patients With Clinical Cure at the End of Treatment (EOT) Visit in the Microbiological Modified Intent-to-treat (mMITT) Analysis Set. | Indeterminate | 11 Number of patients |
| Meropenem | The Proportion of Patients With Clinical Cure at the End of Treatment (EOT) Visit in the Microbiological Modified Intent-to-treat (mMITT) Analysis Set. | Clinical cure | 140 Number of patients |
| Meropenem | The Proportion of Patients With Clinical Cure at the End of Treatment (EOT) Visit in the Microbiological Modified Intent-to-treat (mMITT) Analysis Set. | Clinical failure | 7 Number of patients |
| Meropenem | The Proportion of Patients With Clinical Cure at the End of Treatment (EOT) Visit in the Microbiological Modified Intent-to-treat (mMITT) Analysis Set. | Indeterminate | 5 Number of patients |
Secondary
The Proportion of Patients With Clinical Cure at the Late Follow up (LFU) Visit in the Clinically Evaluable (CE) Analysis Set.
The proportion of patients meeting the cure criteria: complete resolution or significant improvement of signs and symptoms of the index infection such that no further antibacterial therapy, drainage, or surgical intervention was necessary.
Time frame: At late follow up (LFU) visits (Day 42 to 49)
Population: The clinically evaluable (CE) analysis set included all patients who met the disease definition of cIAI and met the stringent criteria for clinical evaluation described in the protocol regarding dosing, concomitant medication, evaluation, etc.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ceftazidime-Avibactam Plus Metronidazole | The Proportion of Patients With Clinical Cure at the Late Follow up (LFU) Visit in the Clinically Evaluable (CE) Analysis Set. | Clinical failure | 11 Number of patients |
| Ceftazidime-Avibactam Plus Metronidazole | The Proportion of Patients With Clinical Cure at the Late Follow up (LFU) Visit in the Clinically Evaluable (CE) Analysis Set. | Clinical cure | 157 Number of patients |
| Meropenem | The Proportion of Patients With Clinical Cure at the Late Follow up (LFU) Visit in the Clinically Evaluable (CE) Analysis Set. | Clinical cure | 168 Number of patients |
| Meropenem | The Proportion of Patients With Clinical Cure at the Late Follow up (LFU) Visit in the Clinically Evaluable (CE) Analysis Set. | Clinical failure | 11 Number of patients |
Secondary
The Proportion of Patients With Clinical Cure at the Late Follow up (LFU) Visit in the Extended Microbiologically Evaluable (ME) Analysis Set.
The proportion of patients meeting the cure criteria: complete resolution or significant improvement of signs and symptoms of the index infection such that no further antibacterial therapy, drainage, or surgical intervention was necessary.
Time frame: At the late follow up (LFU) (Day 42 to 49)
Population: Extended microbiologically evaluable (ME) analysis set defined as all patients included in the clinically evaluable (CE) set with at least 1 Gram-negative aerobic pathogen in the initial/prestudy culture regardless of susceptibility.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ceftazidime-Avibactam Plus Metronidazole | The Proportion of Patients With Clinical Cure at the Late Follow up (LFU) Visit in the Extended Microbiologically Evaluable (ME) Analysis Set. | Clinical cure | 90 Number of patients |
| Ceftazidime-Avibactam Plus Metronidazole | The Proportion of Patients With Clinical Cure at the Late Follow up (LFU) Visit in the Extended Microbiologically Evaluable (ME) Analysis Set. | Clinical failure | 7 Number of patients |
| Meropenem | The Proportion of Patients With Clinical Cure at the Late Follow up (LFU) Visit in the Extended Microbiologically Evaluable (ME) Analysis Set. | Clinical cure | 106 Number of patients |
| Meropenem | The Proportion of Patients With Clinical Cure at the Late Follow up (LFU) Visit in the Extended Microbiologically Evaluable (ME) Analysis Set. | Clinical failure | 6 Number of patients |
Secondary
The Proportion of Patients With Clinical Cure at the Late Follow up (LFU) Visit in the Microbiologically Evaluable (ME) Analysis Set.
The proportion of patients meeting the cure criteria: complete resolution or significant improvement of signs and symptoms of the index infection such that no further antibacterial therapy, drainage, or surgical intervention was necessary.
Time frame: At the late follow up (LFU) (Day 42 to 49)
Population: Microbiologically evaluable (ME) analysis set defined as all patients included in the clinically evaluable (CE) set with at least 1 Gram-negative aerobic pathogen in the initial/prestudy culture that was susceptible to both treatment groups.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ceftazidime-Avibactam Plus Metronidazole | The Proportion of Patients With Clinical Cure at the Late Follow up (LFU) Visit in the Microbiologically Evaluable (ME) Analysis Set. | Clinical cure | 89 Number of patients |
| Ceftazidime-Avibactam Plus Metronidazole | The Proportion of Patients With Clinical Cure at the Late Follow up (LFU) Visit in the Microbiologically Evaluable (ME) Analysis Set. | Clinical failure | 7 Number of patients |
| Meropenem | The Proportion of Patients With Clinical Cure at the Late Follow up (LFU) Visit in the Microbiologically Evaluable (ME) Analysis Set. | Clinical cure | 100 Number of patients |
| Meropenem | The Proportion of Patients With Clinical Cure at the Late Follow up (LFU) Visit in the Microbiologically Evaluable (ME) Analysis Set. | Clinical failure | 6 Number of patients |
Secondary
The Proportion of Patients With Clinical Cure at the Late Follow up (LFU) Visit in the Microbiological Modified Intent-to-treat (mMITT) Analysis Set.
The proportion of patients meeting the cure criteria: complete resolution or significant improvement of signs and symptoms of the index infection such that no further antibacterial therapy, drainage, or surgical intervention was necessary.
Time frame: At the late follow up (LFU) (Day 42 to 49)
Population: The microbiological modified intent-to-treat mMITT analysis set included all randomized patients who met the disease definition of cIAI and had at least 1 etiologic pathogen identified at study entry (regardless of isolate susceptibilities). Patients with a bacterial species typically not expected to respond to both study drugs were excluded.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ceftazidime-Avibactam Plus Metronidazole | The Proportion of Patients With Clinical Cure at the Late Follow up (LFU) Visit in the Microbiological Modified Intent-to-treat (mMITT) Analysis Set. | Clinical cure | 116 Number of patients |
| Ceftazidime-Avibactam Plus Metronidazole | The Proportion of Patients With Clinical Cure at the Late Follow up (LFU) Visit in the Microbiological Modified Intent-to-treat (mMITT) Analysis Set. | Clinical failure | 10 Number of patients |
| Ceftazidime-Avibactam Plus Metronidazole | The Proportion of Patients With Clinical Cure at the Late Follow up (LFU) Visit in the Microbiological Modified Intent-to-treat (mMITT) Analysis Set. | Indeterminate | 17 Number of patients |
| Meropenem | The Proportion of Patients With Clinical Cure at the Late Follow up (LFU) Visit in the Microbiological Modified Intent-to-treat (mMITT) Analysis Set. | Clinical cure | 132 Number of patients |
| Meropenem | The Proportion of Patients With Clinical Cure at the Late Follow up (LFU) Visit in the Microbiological Modified Intent-to-treat (mMITT) Analysis Set. | Clinical failure | 9 Number of patients |
| Meropenem | The Proportion of Patients With Clinical Cure at the Late Follow up (LFU) Visit in the Microbiological Modified Intent-to-treat (mMITT) Analysis Set. | Indeterminate | 11 Number of patients |
Secondary
The Proportion of Patients With Clinical Cure at the Test of Cure (TOC) Visit in the Extended Microbiologically Evaluable (ME) Analysis Set.
The proportion of patients meeting the cure criteria: complete resolution or significant improvement of signs and symptoms of the index infection such that no further antibacterial therapy, drainage, or surgical intervention was necessary.
Time frame: At the test of cure (TOC) (Day 28 to 35)
Population: Extended microbiologically evaluable (ME) analysis set defined as all patients included in the clinically evaluable (CE) set with at least 1 Gram-negative aerobic pathogen in the initial/prestudy culture regardless of susceptibility.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ceftazidime-Avibactam Plus Metronidazole | The Proportion of Patients With Clinical Cure at the Test of Cure (TOC) Visit in the Extended Microbiologically Evaluable (ME) Analysis Set. | Clinical cure | 93 Number of patients |
| Ceftazidime-Avibactam Plus Metronidazole | The Proportion of Patients With Clinical Cure at the Test of Cure (TOC) Visit in the Extended Microbiologically Evaluable (ME) Analysis Set. | Clinical failure | 7 Number of patients |
| Meropenem | The Proportion of Patients With Clinical Cure at the Test of Cure (TOC) Visit in the Extended Microbiologically Evaluable (ME) Analysis Set. | Clinical cure | 113 Number of patients |
| Meropenem | The Proportion of Patients With Clinical Cure at the Test of Cure (TOC) Visit in the Extended Microbiologically Evaluable (ME) Analysis Set. | Clinical failure | 6 Number of patients |
Secondary
The Proportion of Patients With Clinical Cure at the Test of Cure (TOC) Visit in the Microbiologically Evaluable (ME) Analysis Set.
The proportion of patients meeting the cure criteria: complete resolution or significant improvement of signs and symptoms of the index infection such that no further antibacterial therapy, drainage, or surgical intervention was necessary.
Time frame: At the test of cure (TOC) (Day 28 to 35)
Population: Microbiologically evaluable (ME) analysis set defined as all patients included in the clinically evaluable (CE) set with at least 1 Gram-negative aerobic pathogen in the initial/prestudy culture that was susceptible to both treatment groups.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ceftazidime-Avibactam Plus Metronidazole | The Proportion of Patients With Clinical Cure at the Test of Cure (TOC) Visit in the Microbiologically Evaluable (ME) Analysis Set. | Clinical failure | 7 Number of patients |
| Ceftazidime-Avibactam Plus Metronidazole | The Proportion of Patients With Clinical Cure at the Test of Cure (TOC) Visit in the Microbiologically Evaluable (ME) Analysis Set. | Clinical cure | 92 Number of patients |
| Meropenem | The Proportion of Patients With Clinical Cure at the Test of Cure (TOC) Visit in the Microbiologically Evaluable (ME) Analysis Set. | Clinical cure | 107 Number of patients |
| Meropenem | The Proportion of Patients With Clinical Cure at the Test of Cure (TOC) Visit in the Microbiologically Evaluable (ME) Analysis Set. | Clinical failure | 6 Number of patients |
Secondary
The Proportion of Patients With Clinical Cure at the Test of Cure (TOC) Visit in the Microbiological Modified Intent-to-treat (mMITT) Analysis Set.
The proportion of patients meeting the cure criteria: complete resolution or significant improvement of signs and symptoms of the index infection such that no further antibacterial therapy, drainage, or surgical intervention was necessary.
Time frame: At the test of cure (TOC) (Day 28 to 35)
Population: The microbiological modified intent-to-treat mMITT analysis set included all randomized patients who met the disease definition of cIAI and had at least 1 etiologic pathogen identified at study entry (regardless of isolate susceptibilities). Patients with a bacterial species typically not expected to respond to both study drugs were excluded.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ceftazidime-Avibactam Plus Metronidazole | The Proportion of Patients With Clinical Cure at the Test of Cure (TOC) Visit in the Microbiological Modified Intent-to-treat (mMITT) Analysis Set. | Clinical cure | 119 Number of patients |
| Ceftazidime-Avibactam Plus Metronidazole | The Proportion of Patients With Clinical Cure at the Test of Cure (TOC) Visit in the Microbiological Modified Intent-to-treat (mMITT) Analysis Set. | Clinical failure | 10 Number of patients |
| Ceftazidime-Avibactam Plus Metronidazole | The Proportion of Patients With Clinical Cure at the Test of Cure (TOC) Visit in the Microbiological Modified Intent-to-treat (mMITT) Analysis Set. | Indeterminate | 14 Number of patients |
| Meropenem | The Proportion of Patients With Clinical Cure at the Test of Cure (TOC) Visit in the Microbiological Modified Intent-to-treat (mMITT) Analysis Set. | Clinical cure | 135 Number of patients |
| Meropenem | The Proportion of Patients With Clinical Cure at the Test of Cure (TOC) Visit in the Microbiological Modified Intent-to-treat (mMITT) Analysis Set. | Clinical failure | 9 Number of patients |
| Meropenem | The Proportion of Patients With Clinical Cure at the Test of Cure (TOC) Visit in the Microbiological Modified Intent-to-treat (mMITT) Analysis Set. | Indeterminate | 8 Number of patients |
Secondary
The Time to First Defervescence in the Clinically Evaluable (CE) Analysis Set for Patients Who Have Fever at Study Entry.
Time to first defervescence was calculated for patients with a fever (\>38ºC) at baseline. Defervescence (≤37.8ºC) was defined as the absence of fever based on the highest temperature recorded on each study day. Time to first defervescence while on IV study therapy in the CE analysis set at TOC for patients who had fever at study entry is defined as time (in days) from the first dose of IV study therapy to first absence of fever.
Time frame: while on study therapy (from Day 1 to Day 14)
Population: Clinically evaluable (CE) with fever, defined as \>38ºC at study entry. No participants were censored at the time of last observation.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Ceftazidime-Avibactam Plus Metronidazole | The Time to First Defervescence in the Clinically Evaluable (CE) Analysis Set for Patients Who Have Fever at Study Entry. | 1 Days |
| Meropenem | The Time to First Defervescence in the Clinically Evaluable (CE) Analysis Set for Patients Who Have Fever at Study Entry. | 1.5 Days |
p-value: 0.773Log Rank
Secondary
The Time to First Defervescence in the Microbiological Modified Intent-to-treat (mMITT) Analysis Set for Patients Who Have Fever at Study Entry.
Time to first defervescence was calculated for patients with a fever (\>38ºC) at baseline. Defervescence (≤37.8ºC) was defined as the absence of fever based on the highest temperature recorded on each study day. Time to first defervescence while on IV study therapy in the CE analysis set at TOC for patients who had fever at study entry is defined as time (in days) from the first dose of IV study therapy to first absence of fever.
Time frame: while on study therapy (from Day 1 to Day 14)
Population: microbiological modified intent-to-treat (mMITT) with fever, defined as \>38ºC at study entry. No participants were censored at the time of last observation.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Ceftazidime-Avibactam Plus Metronidazole | The Time to First Defervescence in the Microbiological Modified Intent-to-treat (mMITT) Analysis Set for Patients Who Have Fever at Study Entry. | 1 Days |
| Meropenem | The Time to First Defervescence in the Microbiological Modified Intent-to-treat (mMITT) Analysis Set for Patients Who Have Fever at Study Entry. | 2 Days |
p-value: 0.598Log Rank