Complicated Urinary Tract Infection, Complicated Intra-abdominal Infection
Conditions
Keywords
Ceftazidime,, avibactam,, metronidazone,, Anti-Infectives
Brief summary
To Evaluate the Effects of Ceftazidime-Avibactam and Best Available Therapy in patients with complicated urinary tract infections and complicated intra-abdominal infections.
Detailed description
An Open-Label, Randomized, Multicenter, Phase III Study of Ceftazidime Avibactam (CAZ-AVI, formerly CAZ104) and Best Available Therapy for the Treatment of Infections Due to Ceftazidime Resistant Gram Negative Pathogens
Interventions
Ceftazidime 2000 mg and 500 mg of avibactam Patients randomized to receive CAZ-AVI will receive an infusion of CAZ-AVI (2000 mg ceftazidime and 500 mg avibactam) every 8 hours administered by intravenous (IV) infusion in a volume of 100 mL at a constant rate over 120 minutes
Patients randomized to receive Best Available Therapy will receive the best available standard of care (SOC) anti-infective therapy for their infection administered in accord with approved local label recommendation
DRUGMetronidazole
Anti-infective, 500 mg (cIAI only) Patients randomized to receive CAZ-AVI for cIAI will also receive metronidazole (500 mg) administered by IV infusion in a volume of 100 mL at a constant rate over 60 minutes immediately following the CAZ-AVI infusion
Sponsors
Forest Laboratories
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* Patient must be ≥18 and ≤90 years of age * Female patients can participate if they are surgically sterile or completed menopause or females capable of having children and agree not to attempt pregnancy while receiving IV study therapy and for a period of 7 days after * Patient has a ceftazidime-resistant Gram negative pathogen that was isolated from an appropriate culture within 5 days prior to study entry (ie, within 5 days prior to Screening; the study-qualifying culture), which was determined to be the causative agent of the entry infection
Exclusion criteria
* Patient has an APACHE II score \>30 (cIAI patients only) * Patient has an infection due to Gram negative pathogen that is unlikely to respond to CAZ-AVI treatment (eg, Acinetobacter spp., Stenotrophomonas spp.) * Patient is receiving hemodialysis or peritoneal dialysis or had a renal transplant Patient is immunocompromised * Patient has a rapidly progressive or terminal illness with a high risk of mortality due to any cause, including acute hepatic failure, respiratory failure or severe septic shock such that they are unlikely to survive the 4- to 5-week study period.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Response at Test of Cure (TOC) in Microbiological Modified Intent-to-treat (mMITT) Analysis Set | 6-12 days after last infusion of study therapy. Duration of study therapy was 5 to 21 days. | Proportion of patients with clinical cure at the TOC visit in the mMITT analysis set. Clinical cure: Complete resolution or significant improvement of signs and symptoms of the index infection such that no further antibacterial therapy (other than those allowed per protocol) is necessary; for cIAI patients no drainage or surgical intervention after 96 hours from randomization is necessary (ie. drainage or surgical intervention up to 96 hours from randomization is permissible). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Response at Follow-up 1 (FU1) in mMITT Analysis Set | cIAI: 27-37 calendar days from randomization/cUTI: 20-27 calendar days from randomization | Proportion of patients with clinical cure at the FU1 visit in the mMITT analysis set. Clinical cure: Complete resolution or significant improvement of signs and symptoms of the index infection such that no further antibacterial therapy (other than those allowed per protocol) is necessary; for cIAI patients no drainage or surgical intervention after 96 hours from randomization is necessary (ie. drainage or surgical intervention up to 96 hours from randomization is permissible). |
| Clinical Response at Follow-up 2 (FU2) in mMITT Analysis Set | At FU2, data was only collected for the cUTI Arms: 28-34 calendar days from randomization | Proportion of patients with clinical cure at the FU2 visit in the mMITT analysis set. Clinical cure: Complete resolution or significant improvement of signs and symptoms of the index infection such that no further antibacterial therapy (other than those allowed per protocol) is necessary; for cIAI patients no drainage or surgical intervention after 96 hours from randomization is necessary (ie. drainage or surgical intervention up to 96 hours from randomization is permissible). |
| Clinical Response at EOT in Extended Microbiologically Evaluable (EME) at EOT Analysis Set. | 28 hours after completion of last infusion of study therapy. Duration of study therapy was 5 to 21 days. | Proportion of patients with clinical cure at the EOT visit in the EME at EOT analysis set. Clinical cure: Complete resolution or significant improvement of signs and symptoms of the index infection such that no further antibacterial therapy (other than those allowed per protocol) is necessary; for cIAI patients no drainage or surgical intervention after 96 hours from randomization is necessary (ie. drainage or surgical intervention up to 96 hours from randomization is permissible). |
| Clinical Response at TOC in EME at TOC Analysis Set. | 6-12 days after last infusion of study therapy.Duration of study therapy was 5 to 21 days. | Proportion of patients with clinical cure at the TOC visit in the EME at TOC analysis set. Clinical cure: Complete resolution or significant improvement of signs and symptoms of the index infection such that no further antibacterial therapy (other than those allowed per protocol) is necessary; for cIAI patients no drainage or surgical intervention after 96 hours from randomization is necessary (ie. drainage or surgical intervention up to 96 hours from randomization is permissible). |
| Clinical Response at FU1 in EME at FU1 Analysis Set. | cIAI: 27-37 calendar days from randomization/cUTI: 20-27 calendar days from randomization | Proportion of patients with clinical cure at the FU1 visit in EME at FU1 analysis set. Clinical cure: Complete resolution or significant improvement of signs and symptoms of the index infection such that no further antibacterial therapy (other than those allowed per protocol) is necessary; for cIAI patients no drainage or surgical intervention after 96 hours from randomization is necessary (ie. drainage or surgical intervention up to 96 hours from randomization is permissible). |
| Clinical Response at FU2 in EME at FU2 Analysis Set | At FU2, data was only collected for the cUTI Arms: 28-34 calendar days from randomization | Proportion of patients with clinical cure at the FU2 visit in EME at FU2 analysis set. Clinical cure: Complete resolution or significant improvement of signs and symptoms of the index infection such that no further antibacterial therapy (other than those allowed per protocol) is necessary. |
| Clinical Cure at TOC by Baseline Gram-negative Pathogen in mMITT Analysis Set | 6-12 days after last infusion of study therapy.Duration of study therapy was 5 to 21 days. | Proportion of patients with clinical cure at TOC visit by baseline pathogen (\>=10% of frequency in the combined cIAI and cUTI patients) in the mMITT analysis set. Clinical cure: Complete resolution or significant improvement of signs and symptoms of the index infection such that no further antibacterial therapy (other than those allowed per protocol) is necessary; for cIAI patients no drainage or surgical intervention after 96 hours from randomization is necessary (ie. drainage or surgical intervention up to 96 hours from randomization is permissible). |
| Clinical Cure at TOC by Baseline Gram-negative Pathogen in EME at TOC Analysis Set | 6-12 days after last infusion of study therapy.Duration of study therapy was 5 to 21 days. | Proportion of patients with clinical cure at TOC visit by baseline Gram-negative pathogen (\>=10% of frequency in the combined cIAI and cUTI patients) in EME at TOC analysis set. Clinical cure: Complete resolution or significant improvement of signs and symptoms of the index infection such that no further antibacterial therapy (other than those allowed per protocol) is necessary; for cIAI patients no drainage or surgical intervention after 96 hours from randomization is necessary (ie. drainage or surgical intervention up to 96 hours from randomization is permissible). |
| Clinical Cure at TOC by Previously Failed Treatment Class in mMITT Analysis Set | 6-12 days after last infusion of study therapy. Duration of study therapy was 5 to 21 days. | Proportion of patients with clinical cure at TOC visit by previously failed treatment class in the mMITT analysis set. Clinical cure: Complete resolution or significant improvement of signs and symptoms of the index infection such that no further antibacterial therapy (other than those allowed per protocol) is necessary; for cIAI patients no drainage or surgical intervention after 96 hours from randomization is necessary (ie. drainage or surgical intervention up to 96 hours from randomization is permissible). |
| Clinical Cure at EOT by Previously Failed Treatment Class in EME at EOT Analysis Set | 28 hours after completion of last infusion of study therapy.Duration of study therapy was 5 to 21 days. | Proportion of patients with clinical cure at EOT visit by previously failed treatment class in EME at EOT analysis set. Clinical cure: Complete resolution or significant improvement of signs and symptoms of the index infection such that no further antibacterial therapy (other than those allowed per protocol) is necessary; for cIAI patients no drainage or surgical intervention after 96 hours from randomization is necessary (ie. drainage or surgical intervention up to 96 hours from randomization is permissible). |
| Clinical Cure at TOC by Previously Failed Treatment Class in EME at TOC Analysis Set | 6-12 days after last infusion of study therapy. Duration of study therapy was 5 to 21 days. | Proportion of patients with clinical cure at TOC visit by previously failed treatment class in EME at TOC analysis set. Clinical cure: Complete resolution or significant improvement of signs and symptoms of the index infection such that no further antibacterial therapy (other than those allowed per protocol) is necessary; for cIAI patients no drainage or surgical intervention after 96 hours from randomization is necessary (ie. drainage or surgical intervention up to 96 hours from randomization is permissible). |
| Clinical Cure at FU1 by Previously Failed Treatment Class in EME at FU1 Analysis Set | cIAI: 27-37 calendar days from randomization/cUTI: 20-27 calendar days from randomization | Proportion of patients with clinical cure at FU1 visit by previously failed treatment class in EME at FU1 analysis set. Clinical cure: Complete resolution or significant improvement of signs and symptoms of the index infection such that no further antibacterial therapy (other than those allowed per protocol) is necessary; for cIAI patients no drainage or surgical intervention after 96 hours from randomization is necessary (ie. drainage or surgical intervention up to 96 hours from randomization is permissible). |
| Clinical Cure at FU2 by Previously Failed Treatment Class in EME at FU2 Analysis Set | At FU2, data was only collected for the cUTI Arms: 28-34 calendar days from randomization | Proportion of patients with clinical cure at FU2 visit by previously failed treatment class in EME at FU2 analysis set. Clinical cure: Complete resolution or significant improvement of signs and symptoms of the index infection such that no further antibacterial therapy (other than those allowed per protocol) is necessary. |
| Per-patient Microbiological Response at EOT in mMITT Analysis Set | 28 hours after completion of last infusion of study therapy. Duration of study therapy was 5 to 21 days. | 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 cIAI patients where the clinical response was changed to indeterminate due to a Surgical Review Panel assessment of inadequate source control (ie, circumstances that preclude classification as eradication, presumed eradication, persistence, persistence with increasing MIC, and presumed persistence). |
| Per-patient Microbiological Response at TOC in mMITT Analysis Set | 6-12 days after last infusion of study therapy. Duration of study therapy was 5 to 21 days. | 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 cIAI patients where the clinical response was changed to indeterminate due to a Surgical Review Panel assessment of inadequate source control (ie, circumstances that preclude classification as eradication, presumed eradication, persistence, persistence with increasing MIC, and presumed persistence). |
| Per-patient Microbiological Response at FU1 in mMITT Analysis Set | cUTI: 20-27 calendar days from randomization/cIAI: 27-37 calendar days from randomization | 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 cIAI patients where the clinical response was changed to indeterminate due to a Surgical Review Panel assessment of inadequate source control (ie, circumstances that preclude classification as eradication, presumed eradication, persistence, persistence with increasing MIC, and presumed persistence). |
| Per-patient Microbiological Response at FU2 in mMITT Analysis Set | At FU2, data was only collected for the cUTI Arms: 28-34 calendar days from randomization | 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 cIAI patients where the clinical response was changed to indeterminate due to a Surgical Review Panel assessment of inadequate source control (ie, circumstances that preclude classification as eradication, presumed eradication, persistence, persistence with increasing MIC, and presumed persistence). |
| Per-patient Microbiological Response at EOT in EME at EOT Analysis Set | 28 hours after completion of last infusion of study therapy. Duration of study therapy was 5 to 21 days. | 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 cIAI patients where the clinical response was changed to indeterminate due to a Surgical Review Panel assessment of inadequate source control (ie, circumstances that preclude classification as eradication, presumed eradication, persistence, persistence with increasing MIC, and presumed persistence). |
| Clinical Response at End of Treatment (EOT) in mMITT Analysis Set. | 28 hours after completion of last infusion of study therapy. Duration of study therapy was 5 to 21 days. | Proportion of patients with clinical cure at the EOT visit in the mMITT analysis set. Clinical cure: Complete resolution or significant improvement of signs and symptoms of the index infection such that no further antibacterial therapy (other than those allowed per protocol) is necessary; for cIAI patients no drainage or surgical intervention after 96 hours from randomization is necessary (ie. drainage or surgical intervention up to 96 hours from randomization is permissible). |
| Per-patient Microbiological Response at FU1 in EME at FU1 Analysis Set | cUTI: 20-27 calendar days from randomization/cIAI: 27-37 calendar days from randomization | 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 cIAI patients where the clinical response was changed to indeterminate due to a Surgical Review Panel assessment of inadequate source control (ie, circumstances that preclude classification as eradication, presumed eradication, persistence, persistence with increasing MIC, and presumed persistence). |
| Per-patient Microbiological Response at FU2 in EME at FU2 Analysis Set | At FU2, data was only collected for the cUTI Arms: 28-34 calendar days from randomization | 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 cIAI patients where the clinical response was changed to indeterminate due to a Surgical Review Panel assessment of inadequate source control (ie, circumstances that preclude classification as eradication, presumed eradication, persistence, persistence with increasing MIC, and presumed persistence). |
| Per-pathogen Microbiological Response of Gram-negative Pathogen at EOT in mMITT Analysis Set | 28 hours after completion of last infusion of study therapy. Duration of study therapy was 5 to 21 days. | Proportion of patients with a favorable per-pathogen microbiological response for pathogens (\>=10% of frequency in the combined cIAI and cUTI patients): favourable microbiological response includes: Eradication Absence (or urine quantification less than 10\^4 CFU/ml for cUTI patients) of causative pathogen from an appropriately obtained specimen at the site of infection. If the patient was bacteremic at Screening, the bacteremia has also resolved. Presumed eradication where, repeat cultures were not performed/clinically indicated in a patient who had a clinical response of cure (specific to cIAI population). |
| Per-pathogen Microbiological Response of Gram-negative Pathogen at TOC in mMITT Analysis Set | 6-12 days after last infusion of study therapy. Duration of study therapy was 5 to 21 days. | Proportion of patients with a favorable per-pathogen microbiological response for pathogens (\>=10% of frequency in the combined cIAI and cUTI patients): favourable microbiological response includes: Eradication Absence (or urine quantification less than 10\^4 CFU/ml for cUTI patients) of causative pathogen from an appropriately obtained specimen at the site of infection. If the patient was bacteremic at Screening, the bacteremia has also resolved. Presumed eradication where, repeat cultures were not performed/clinically indicated in a patient who had a clinical response of cure (specific to cIAI population). |
| Per-pathogen Microbiological Response of Gram-negative Pathogen at FU1 in mMITT Analysis Set | cIAI: 27-37 calendar days from randomization/cUTI: 20-27 calendar days from randomization | Proportion of patients with a favorable per-pathogen microbiological response for pathogens (\>=10% of frequency in the combined cIAI and cUTI patients): favourable microbiological response includes: Eradication Absence (or urine quantification less than 10\^4 CFU/ml for cUTI patients) of causative pathogen from an appropriately obtained specimen at the site of infection. If the patient was bacteremic at Screening, the bacteremia has also resolved. Presumed eradication where, repeat cultures were not performed/clinically indicated in a patient who had a clinical response of cure (specific to cIAI population). |
| Per-pathogen Microbiological Response of Gram-negative Pathogen at FU2 in mMITT Analysis Set | At FU2, data was only collected for the cUTI Arms: 28-34 calendar days from randomization | Proportion of patients with a favorable per-pathogen microbiological response for pathogens (\>=10% of frequncy in the combined cIAI and cUTI patients): favourable microbiological response includes: Eradication Absence (or urine quantification less than 10\^4 CFU/ml for cUTI patients) of causative pathogen from an appropriately obtained specimen at the site of infection. If the patient was bacteremic at Screening, the bacteremia has also resolved. Presumed eradication where, repeat cultures were not performed/clinically indicated in a patient who had a clinical response of cure (specific to cIAI population). |
| Per-pathogen Microbiological Response of Gram-negative Pathogen at EOT in EME at EOT Analysis Set | 28 hours after completion of last infusion of study therapy. Duration of study therapy was 5 to 21 days. | Proportion of patients with a favorable per-pathogen microbiological response for pathogens (\>=10% of frequncy in the combined cIAI and cUTI patients): favourable microbiological response includes: Eradication Absence (or urine quantification less than 10\^4 CFU/ml for cUTI patients) of causative pathogen from an appropriately obtained specimen at the site of infection. If the patient was bacteremic at Screening, the bacteremia has also resolved. Presumed eradication where, repeat cultures were not performed/clinically indicated in a patient who had a clinical response of cure (specific to cIAI population). |
| Per-pathogen Microbiological Response of Gram-negative Pathogen at TOC in EME at TOC Analysis Set | 6-12 days after last infusion of study therapy. Duration of study therapy was 5 to 21 days. | Proportion of patients with a favorable per-pathogen microbiological response for pathogens (\>=10% of frequncy in the combined cIAI and cUTI patients): favourable microbiological response includes: Eradication Absence (or urine quantification less than 10\^4 CFU/ml for cUTI patients) of causative pathogen from an appropriately obtained specimen at the site of infection. If the patient was bacteremic at Screening, the bacteremia has also resolved. Presumed eradication where, repeat cultures were not performed/clinically indicated in a patient who had a clinical response of cure (specific to cIAI population). |
| Per-pathogen Microbiological Response of Gram-negative Pathogen at FU1 in EME at FU1 Analysis Set | cIAI: 27-37 calendar days from randomization/cUTI: 20-27 calendar days from randomization | Proportion of patients with a favorable per-pathogen microbiological response for pathogens (\>=10% of frequncy in the combined cIAI and cUTI patients): favourable microbiological response includes: Eradication Absence (or urine quantification less than 10\^4 CFU/ml for cUTI patients) of causative pathogen from an appropriately obtained specimen at the site of infection. If the patient was bacteremic at Screening, the bacteremia has also resolved. Presumed eradication where, repeat cultures were not performed/clinically indicated in a patient who had a clinical response of cure (specific to cIAI population). |
| Per-pathogen Microbiological Response of Gram-negative Pathogen at FU2 in EME at FU2 Analysis Set | At FU2, data was only collected for the cUTI Arms: 28-34 calendar days from randomization | Proportion of patients with a favorable per-pathogen microbiological response for pathogens (\>=10% of frequncy in the combined cIAI and cUTI patients): favourable microbiological response includes: Eradication Absence (or urine quantification less than 10\^4 CFU/ml for cUTI patients) of causative pathogen from an appropriately obtained specimen at the site of infection. If the patient was bacteremic at Screening, the bacteremia has also resolved. Presumed eradication where, repeat cultures were not performed/clinically indicated in a patient who had a clinical response of cure (specific to cIAI population). |
| Per-pathogen Microbiological Response of Gram-negative Pathogen at TOC by CAZ-AVI MIC in mMITT Analysis Set | 6-12 days after last infusion of study therapy. Duration of study therapy was 5 to 21 days. | Proportion of patients with a favorable per-pathogen microbiological response for pathogens (\>=10% of frequncy in the combined cIAI and cUTI patients): favourable microbiological response includes: Eradication Absence (or urine quantification less than 10\^4 CFU/ml for cUTI patients) of causative pathogen from an appropriately obtained specimen at the site of infection. If the patient was bacteremic at Screening, the bacteremia has also resolved. Presumed eradication where, repeat cultures were not performed/clinically indicated in a patient who had a clinical response of cure (specific to cIAI population). For E.coli, MIC available values are: \<=0.008, 0.03, 0.06, 0.12, 0.25, 0.5, 1, 2, 8. For K. pneumoniae, MIC available values are: 0.06, 0.12, 0.25, 0.5, 1, 2, 4, 32, \>32. For P. aeruginosa, MIC available values are: 2, 4, 8, 16, 32, \>32. |
| Per-pathogen Microbiological Response of Gram-negative Pathogen at TOC by CAZ-AVI MIC in EME at TOC Analysis Set | 6-12 days after last infusion of study therapy. Duration of study therapy was 5 to 21 days. | Proportion of patients with a favorable per-pathogen microbiological response for pathogens (\>=10% of frequncy in the combined cIAI and cUTI patients): favourable microbiological response includes: Eradication Absence (or urine quantification less than 10\^4 CFU/ml for cUTI patients) of causative pathogen from an appropriately obtained specimen at the site of infection. If the patient was bacteremic at Screening, the bacteremia has also resolved. Presumed eradication where, repeat cultures were not performed/clinically indicated in a patient who had a clinical response of cure (specific to cIAI population). For E.coli, MIC available values are: \<=0.008, 0.03, 0.06, 0.12, 0.25, 0.5, 1, 2, 8. For K. pneumoniae, MIC available values are: 0.06, 0.12, 0.25, 0.5, 1, 2, 4, \>32. For P. aeruginosa, MIC available values are: 2, 4, 8, 16, 32, \>32. |
| The Reason for Treatment Change/Discontinuation in mMITT Analysis Set | From first infusion to last infusion of study therapy. Duration of study therapy was 5 to 21 days. | Proportion of patients in the mMITT analysis set for whom the assigned study treatment was changed, discontinued, or interrupted. Creatinine clearance (CrCl) |
| The 28 Days All Cause Mortality Rate in mMITT Analysis Set | From first infusion to Day 28 | Proportion of patients with Day 28 all-cause mortality in mMITT analysis set. The death in the cIAI patient were reviewed independently by the SRP Chair. |
| The 28 Days All Cause Mortality Rate in EME at TOC Analysis Set | From first infusion to Day 28 | Proportion of patients with Day 28 all-cause mortality in EME at TOC analysis set. The death in the cIAI patient were reviewed independently by the SRP Chair. |
| Plasma Concentrations for Ceftazidime and Avibactam - cIAI in PK Analysis Set | Anytime within 15 minutes prior to or after stopping study drug, anytime between 30 to 90 minutes after stopping study drug, anytime between 300 to 360 minutes after stopping study drug | Blood samples were taken on Day 3 for ceftazidime and avibactam plasma concentration. |
| Plasma Concentrations for Ceftazidime and Avibactam - cUTI in PK Analysis Set | Anytime within 15 minutes prior to or after stopping study drug, anytime between 30 to 90 minutes after stopping study drug, anytime between 300 to 360 minutes after stopping study drug | Blood samples were taken on Day 3 for ceftazidime and avibactam plasma concentration. |
| Per-patient Microbiological Response at TOC in EME at TOC Analysis Set | 6-12 days after last infusion of study therapy.Duration of study therapy was 5 to 21 days. | 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 cIAI patients where the clinical response was changed to indeterminate due to a Surgical Review Panel assessment of inadequate source control (ie, circumstances that preclude classification as eradication, presumed eradication, persistence, persistence with increasing MIC, and presumed persistence). |
Countries
Argentina, Bulgaria, Croatia, Czechia, France, Israel, Mexico, Peru, Philippines, Poland, Romania, Russia, South Africa, South Korea, Spain, Turkey (Türkiye), Ukraine, United States
Participant flow
Recruitment details
A total of 333 patients were randomized in 53 centers in 16 countries: 306 patients had complicated urinary tract infection (cUTI) and 27 patients had complicated intra-abdominal infection (cIAI). The first patient was randomized on 07JAN2013 and the last patient was randomized on 29AUG2014. One patient in CAZ-AVI arm didn't receive study drug.
Participants by arm
| Arm | Count |
|---|---|
| cIAI:Best Available Therapy cIAI: Best Available Therapy Determinated by Investigator | 11 |
| cIAI:CAZ-AVI + Metronidazole cIAI:CAZ-AVI (2000 mg ceftazidime/500 mg avibactam) plus metronidazole (500 mg) | 10 |
| cUTI:Best Available Therapy cUTI:Best Available Therapy Determinated by Investigator | 137 |
| cUTI:CAZ-AVI cUTI: CAZ-AVI | 144 |
| Total | 302 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Death | 1 | 0 | 3 | 3 |
| Overall Study | Lost to Follow-up | 0 | 0 | 0 | 4 |
| Overall Study | Other Eligibility criteria | 0 | 0 | 0 | 2 |
| Overall Study | Withdrawal by Subject | 1 | 0 | 2 | 1 |
Baseline characteristics
| Characteristic | Total | cIAI:Best Available Therapy | cIAI:CAZ-AVI + Metronidazole | cUTI:Best Available Therapy | cUTI:CAZ-AVI |
|---|---|---|---|---|---|
| Age, Continuous | 62.6 Years STANDARD_DEVIATION 15.12 | 68.4 Years STANDARD_DEVIATION 11.12 | 49.9 Years STANDARD_DEVIATION 16.14 | 61.3 Years STANDARD_DEVIATION 15.33 | 64.3 Years STANDARD_DEVIATION 14.64 |
| Age, Customized 18-45 Years | 43 Participants | 0 Participants | 3 Participants | 21 Participants | 19 Participants |
| Age, Customized 46-64 Years | 98 Participants | 3 Participants | 5 Participants | 49 Participants | 41 Participants |
| Age, Customized 65-74 Years | 92 Participants | 4 Participants | 2 Participants | 40 Participants | 46 Participants |
| Age, Customized 75-90 Years | 69 Participants | 4 Participants | 0 Participants | 27 Participants | 38 Participants |
| Race/Ethnicity, Customized Asian | 3 Participants | 0 Participants | 0 Participants | 1 Participants | 2 Participants |
| Race/Ethnicity, Customized Black Or African American | 4 Participants | 0 Participants | 1 Participants | 1 Participants | 2 Participants |
| Race/Ethnicity, Customized Other | 8 Participants | 0 Participants | 0 Participants | 4 Participants | 4 Participants |
| Race/Ethnicity, Customized White | 287 Participants | 11 Participants | 9 Participants | 131 Participants | 136 Participants |
| Sex: Female, Male Female | 137 Participants | 4 Participants | 6 Participants | 63 Participants | 64 Participants |
| Sex: Female, Male Male | 165 Participants | 7 Participants | 4 Participants | 74 Participants | 80 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 12 / 15 | 8 / 12 | 36 / 153 | 18 / 152 |
| serious Total, serious adverse events | 5 / 15 | 2 / 12 | 5 / 153 | 7 / 152 |
Outcome results
Primary
Clinical Response at Test of Cure (TOC) in Microbiological Modified Intent-to-treat (mMITT) Analysis Set
Proportion of patients with clinical cure at the TOC visit in the mMITT analysis set. Clinical cure: Complete resolution or significant improvement of signs and symptoms of the index infection such that no further antibacterial therapy (other than those allowed per protocol) is necessary; for cIAI patients no drainage or surgical intervention after 96 hours from randomization is necessary (ie. drainage or surgical intervention up to 96 hours from randomization is permissible).
Time frame: 6-12 days after last infusion of study therapy. Duration of study therapy was 5 to 21 days.
Population: Microbiological modified intent to treat
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| cIAI:Best Available Therapy | Clinical Response at Test of Cure (TOC) in Microbiological Modified Intent-to-treat (mMITT) Analysis Set | Indeterminate | 5 Participant |
| cIAI:Best Available Therapy | Clinical Response at Test of Cure (TOC) in Microbiological Modified Intent-to-treat (mMITT) Analysis Set | Clinical cure | 6 Participant |
| cIAI:Best Available Therapy | Clinical Response at Test of Cure (TOC) in Microbiological Modified Intent-to-treat (mMITT) Analysis Set | Clinical failure | 0 Participant |
| cIAI:CAZ-AVI + Metronidazole | Clinical Response at Test of Cure (TOC) in Microbiological Modified Intent-to-treat (mMITT) Analysis Set | Clinical failure | 0 Participant |
| cIAI:CAZ-AVI + Metronidazole | Clinical Response at Test of Cure (TOC) in Microbiological Modified Intent-to-treat (mMITT) Analysis Set | Clinical cure | 8 Participant |
| cIAI:CAZ-AVI + Metronidazole | Clinical Response at Test of Cure (TOC) in Microbiological Modified Intent-to-treat (mMITT) Analysis Set | Indeterminate | 2 Participant |
| cUTI:Best Available Therapy | Clinical Response at Test of Cure (TOC) in Microbiological Modified Intent-to-treat (mMITT) Analysis Set | Indeterminate | 6 Participant |
| cUTI:Best Available Therapy | Clinical Response at Test of Cure (TOC) in Microbiological Modified Intent-to-treat (mMITT) Analysis Set | Clinical cure | 129 Participant |
| cUTI:Best Available Therapy | Clinical Response at Test of Cure (TOC) in Microbiological Modified Intent-to-treat (mMITT) Analysis Set | Clinical failure | 2 Participant |
| cUTI:CAZ-AVI | Clinical Response at Test of Cure (TOC) in Microbiological Modified Intent-to-treat (mMITT) Analysis Set | Clinical failure | 2 Participant |
| cUTI:CAZ-AVI | Clinical Response at Test of Cure (TOC) in Microbiological Modified Intent-to-treat (mMITT) Analysis Set | Clinical cure | 132 Participant |
| cUTI:CAZ-AVI | Clinical Response at Test of Cure (TOC) in Microbiological Modified Intent-to-treat (mMITT) Analysis Set | Indeterminate | 10 Participant |
Secondary
Clinical Cure at EOT by Previously Failed Treatment Class in EME at EOT Analysis Set
Proportion of patients with clinical cure at EOT visit by previously failed treatment class in EME at EOT analysis set. Clinical cure: Complete resolution or significant improvement of signs and symptoms of the index infection such that no further antibacterial therapy (other than those allowed per protocol) is necessary; for cIAI patients no drainage or surgical intervention after 96 hours from randomization is necessary (ie. drainage or surgical intervention up to 96 hours from randomization is permissible).
Time frame: 28 hours after completion of last infusion of study therapy.Duration of study therapy was 5 to 21 days.
Population: Extended microbiologically evaluable at EOT
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| cIAI:Best Available Therapy | Clinical Cure at EOT by Previously Failed Treatment Class in EME at EOT Analysis Set | First-Gen. Cephalosporins-Clin. cure (n=0,0,2,0) | 0 Participant |
| cIAI:Best Available Therapy | Clinical Cure at EOT by Previously Failed Treatment Class in EME at EOT Analysis Set | Other Aminoglycosides-Clin. cure (n=0,0,1,1) | 0 Participant |
| cIAI:Best Available Therapy | Clinical Cure at EOT by Previously Failed Treatment Class in EME at EOT Analysis Set | Fluoroquinolones - Clin. cure (n=0,2,5,1) | 0 Participant |
| cIAI:Best Available Therapy | Clinical Cure at EOT by Previously Failed Treatment Class in EME at EOT Analysis Set | Antibiotics - Clin. cure (n=0,1,0,0) | 0 Participant |
| cIAI:Best Available Therapy | Clinical Cure at EOT by Previously Failed Treatment Class in EME at EOT Analysis Set | Imidazole Derivatives - Clin. cure (n=1,3,0,0) | 1 Participant |
| cIAI:Best Available Therapy | Clinical Cure at EOT by Previously Failed Treatment Class in EME at EOT Analysis Set | Carbapenems - Clin. cure (n=0,0,1,1) | 0 Participant |
| cIAI:Best Available Therapy | Clinical Cure at EOT by Previously Failed Treatment Class in EME at EOT Analysis Set | Penici. With Ext. Spectrum-Clin. cure(n=0,1,0,0) | 0 Participant |
| cIAI:Best Available Therapy | Clinical Cure at EOT by Previously Failed Treatment Class in EME at EOT Analysis Set | Comb of Sulf/Trime inc Deriv-Clin. cure(n=0,0,2,0) | 0 Participant |
| cIAI:Best Available Therapy | Clinical Cure at EOT by Previously Failed Treatment Class in EME at EOT Analysis Set | Third-Gen.Cephalosporins -Clin. cure(n=2,4,2,2) | 2 Participant |
| cIAI:Best Available Therapy | Clinical Cure at EOT by Previously Failed Treatment Class in EME at EOT Analysis Set | Combs Of Peni. Inc B-Lact. Inhib.-Cure(n=1,3,0,2) | 1 Participant |
| cIAI:Best Available Therapy | Clinical Cure at EOT by Previously Failed Treatment Class in EME at EOT Analysis Set | Other Antibacterials-Clin. cure (n=0,1,1,0) | 0 Participant |
| cIAI:Best Available Therapy | Clinical Cure at EOT by Previously Failed Treatment Class in EME at EOT Analysis Set | Other Antibio. F. Topic. Use-Clin. cure(n=0,0,1,0) | 0 Participant |
| cIAI:Best Available Therapy | Clinical Cure at EOT by Previously Failed Treatment Class in EME at EOT Analysis Set | Cortico,Po. Comb W/Antibio.-Clin. cure(n=0,0,1,0) | 0 Participant |
| cIAI:CAZ-AVI + Metronidazole | Clinical Cure at EOT by Previously Failed Treatment Class in EME at EOT Analysis Set | Combs Of Peni. Inc B-Lact. Inhib.-Cure(n=1,3,0,2) | 3 Participant |
| cIAI:CAZ-AVI + Metronidazole | Clinical Cure at EOT by Previously Failed Treatment Class in EME at EOT Analysis Set | Cortico,Po. Comb W/Antibio.-Clin. cure(n=0,0,1,0) | 0 Participant |
| cIAI:CAZ-AVI + Metronidazole | Clinical Cure at EOT by Previously Failed Treatment Class in EME at EOT Analysis Set | Comb of Sulf/Trime inc Deriv-Clin. cure(n=0,0,2,0) | 0 Participant |
| cIAI:CAZ-AVI + Metronidazole | Clinical Cure at EOT by Previously Failed Treatment Class in EME at EOT Analysis Set | Fluoroquinolones - Clin. cure (n=0,2,5,1) | 2 Participant |
| cIAI:CAZ-AVI + Metronidazole | Clinical Cure at EOT by Previously Failed Treatment Class in EME at EOT Analysis Set | Other Antibacterials-Clin. cure (n=0,1,1,0) | 1 Participant |
| cIAI:CAZ-AVI + Metronidazole | Clinical Cure at EOT by Previously Failed Treatment Class in EME at EOT Analysis Set | Other Antibio. F. Topic. Use-Clin. cure(n=0,0,1,0) | 0 Participant |
| cIAI:CAZ-AVI + Metronidazole | Clinical Cure at EOT by Previously Failed Treatment Class in EME at EOT Analysis Set | Imidazole Derivatives - Clin. cure (n=1,3,0,0) | 3 Participant |
| cIAI:CAZ-AVI + Metronidazole | Clinical Cure at EOT by Previously Failed Treatment Class in EME at EOT Analysis Set | Antibiotics - Clin. cure (n=0,1,0,0) | 1 Participant |
| cIAI:CAZ-AVI + Metronidazole | Clinical Cure at EOT by Previously Failed Treatment Class in EME at EOT Analysis Set | First-Gen. Cephalosporins-Clin. cure (n=0,0,2,0) | 0 Participant |
| cIAI:CAZ-AVI + Metronidazole | Clinical Cure at EOT by Previously Failed Treatment Class in EME at EOT Analysis Set | Penici. With Ext. Spectrum-Clin. cure(n=0,1,0,0) | 1 Participant |
| cIAI:CAZ-AVI + Metronidazole | Clinical Cure at EOT by Previously Failed Treatment Class in EME at EOT Analysis Set | Other Aminoglycosides-Clin. cure (n=0,0,1,1) | 0 Participant |
| cIAI:CAZ-AVI + Metronidazole | Clinical Cure at EOT by Previously Failed Treatment Class in EME at EOT Analysis Set | Carbapenems - Clin. cure (n=0,0,1,1) | 0 Participant |
| cIAI:CAZ-AVI + Metronidazole | Clinical Cure at EOT by Previously Failed Treatment Class in EME at EOT Analysis Set | Third-Gen.Cephalosporins -Clin. cure(n=2,4,2,2) | 4 Participant |
| cUTI:Best Available Therapy | Clinical Cure at EOT by Previously Failed Treatment Class in EME at EOT Analysis Set | First-Gen. Cephalosporins-Clin. cure (n=0,0,2,0) | 2 Participant |
| cUTI:Best Available Therapy | Clinical Cure at EOT by Previously Failed Treatment Class in EME at EOT Analysis Set | Antibiotics - Clin. cure (n=0,1,0,0) | 0 Participant |
| cUTI:Best Available Therapy | Clinical Cure at EOT by Previously Failed Treatment Class in EME at EOT Analysis Set | Carbapenems - Clin. cure (n=0,0,1,1) | 1 Participant |
| cUTI:Best Available Therapy | Clinical Cure at EOT by Previously Failed Treatment Class in EME at EOT Analysis Set | Comb of Sulf/Trime inc Deriv-Clin. cure(n=0,0,2,0) | 2 Participant |
| cUTI:Best Available Therapy | Clinical Cure at EOT by Previously Failed Treatment Class in EME at EOT Analysis Set | Combs Of Peni. Inc B-Lact. Inhib.-Cure(n=1,3,0,2) | 0 Participant |
| cUTI:Best Available Therapy | Clinical Cure at EOT by Previously Failed Treatment Class in EME at EOT Analysis Set | Cortico,Po. Comb W/Antibio.-Clin. cure(n=0,0,1,0) | 1 Participant |
| cUTI:Best Available Therapy | Clinical Cure at EOT by Previously Failed Treatment Class in EME at EOT Analysis Set | Fluoroquinolones - Clin. cure (n=0,2,5,1) | 5 Participant |
| cUTI:Best Available Therapy | Clinical Cure at EOT by Previously Failed Treatment Class in EME at EOT Analysis Set | Imidazole Derivatives - Clin. cure (n=1,3,0,0) | 0 Participant |
| cUTI:Best Available Therapy | Clinical Cure at EOT by Previously Failed Treatment Class in EME at EOT Analysis Set | Other Aminoglycosides-Clin. cure (n=0,0,1,1) | 1 Participant |
| cUTI:Best Available Therapy | Clinical Cure at EOT by Previously Failed Treatment Class in EME at EOT Analysis Set | Other Antibacterials-Clin. cure (n=0,1,1,0) | 1 Participant |
| cUTI:Best Available Therapy | Clinical Cure at EOT by Previously Failed Treatment Class in EME at EOT Analysis Set | Other Antibio. F. Topic. Use-Clin. cure(n=0,0,1,0) | 1 Participant |
| cUTI:Best Available Therapy | Clinical Cure at EOT by Previously Failed Treatment Class in EME at EOT Analysis Set | Penici. With Ext. Spectrum-Clin. cure(n=0,1,0,0) | 0 Participant |
| cUTI:Best Available Therapy | Clinical Cure at EOT by Previously Failed Treatment Class in EME at EOT Analysis Set | Third-Gen.Cephalosporins -Clin. cure(n=2,4,2,2) | 2 Participant |
| cUTI:CAZ-AVI | Clinical Cure at EOT by Previously Failed Treatment Class in EME at EOT Analysis Set | Other Antibacterials-Clin. cure (n=0,1,1,0) | 0 Participant |
| cUTI:CAZ-AVI | Clinical Cure at EOT by Previously Failed Treatment Class in EME at EOT Analysis Set | Combs Of Peni. Inc B-Lact. Inhib.-Cure(n=1,3,0,2) | 2 Participant |
| cUTI:CAZ-AVI | Clinical Cure at EOT by Previously Failed Treatment Class in EME at EOT Analysis Set | Comb of Sulf/Trime inc Deriv-Clin. cure(n=0,0,2,0) | 0 Participant |
| cUTI:CAZ-AVI | Clinical Cure at EOT by Previously Failed Treatment Class in EME at EOT Analysis Set | Fluoroquinolones - Clin. cure (n=0,2,5,1) | 1 Participant |
| cUTI:CAZ-AVI | Clinical Cure at EOT by Previously Failed Treatment Class in EME at EOT Analysis Set | Other Antibio. F. Topic. Use-Clin. cure(n=0,0,1,0) | 0 Participant |
| cUTI:CAZ-AVI | Clinical Cure at EOT by Previously Failed Treatment Class in EME at EOT Analysis Set | Carbapenems - Clin. cure (n=0,0,1,1) | 1 Participant |
| cUTI:CAZ-AVI | Clinical Cure at EOT by Previously Failed Treatment Class in EME at EOT Analysis Set | Antibiotics - Clin. cure (n=0,1,0,0) | 0 Participant |
| cUTI:CAZ-AVI | Clinical Cure at EOT by Previously Failed Treatment Class in EME at EOT Analysis Set | Third-Gen.Cephalosporins -Clin. cure(n=2,4,2,2) | 2 Participant |
| cUTI:CAZ-AVI | Clinical Cure at EOT by Previously Failed Treatment Class in EME at EOT Analysis Set | Imidazole Derivatives - Clin. cure (n=1,3,0,0) | 0 Participant |
| cUTI:CAZ-AVI | Clinical Cure at EOT by Previously Failed Treatment Class in EME at EOT Analysis Set | First-Gen. Cephalosporins-Clin. cure (n=0,0,2,0) | 0 Participant |
| cUTI:CAZ-AVI | Clinical Cure at EOT by Previously Failed Treatment Class in EME at EOT Analysis Set | Cortico,Po. Comb W/Antibio.-Clin. cure(n=0,0,1,0) | 0 Participant |
| cUTI:CAZ-AVI | Clinical Cure at EOT by Previously Failed Treatment Class in EME at EOT Analysis Set | Penici. With Ext. Spectrum-Clin. cure(n=0,1,0,0) | 0 Participant |
| cUTI:CAZ-AVI | Clinical Cure at EOT by Previously Failed Treatment Class in EME at EOT Analysis Set | Other Aminoglycosides-Clin. cure (n=0,0,1,1) | 1 Participant |
Secondary
Clinical Cure at FU1 by Previously Failed Treatment Class in EME at FU1 Analysis Set
Proportion of patients with clinical cure at FU1 visit by previously failed treatment class in EME at FU1 analysis set. Clinical cure: Complete resolution or significant improvement of signs and symptoms of the index infection such that no further antibacterial therapy (other than those allowed per protocol) is necessary; for cIAI patients no drainage or surgical intervention after 96 hours from randomization is necessary (ie. drainage or surgical intervention up to 96 hours from randomization is permissible).
Time frame: cIAI: 27-37 calendar days from randomization/cUTI: 20-27 calendar days from randomization
Population: Extended microbiologically evaluable at FU1
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| cIAI:Best Available Therapy | Clinical Cure at FU1 by Previously Failed Treatment Class in EME at FU1 Analysis Set | Imidazole Derivatives - Clin. cure (n=1,3,0,0) | 1 Participant |
| cIAI:Best Available Therapy | Clinical Cure at FU1 by Previously Failed Treatment Class in EME at FU1 Analysis Set | Combs Of Peni. Inc B-Lact. Inhib.-Cure(n=1,3,0,2) | 1 Participant |
| cIAI:Best Available Therapy | Clinical Cure at FU1 by Previously Failed Treatment Class in EME at FU1 Analysis Set | Antibiotics - Clin. cure (n=0,1,0,0) | 0 Participant |
| cIAI:Best Available Therapy | Clinical Cure at FU1 by Previously Failed Treatment Class in EME at FU1 Analysis Set | Third-Gen.Cephalosporins -Clin. cure(n=2,4,1,2) | 2 Participant |
| cIAI:Best Available Therapy | Clinical Cure at FU1 by Previously Failed Treatment Class in EME at FU1 Analysis Set | Penici. With Ext. Spectrum-Clin. cure(n=0,1,0,0) | 0 Participant |
| cIAI:Best Available Therapy | Clinical Cure at FU1 by Previously Failed Treatment Class in EME at FU1 Analysis Set | Cortico,Po. Comb W/Antibio.-Clin. cure(n=0,0,1,0) | 0 Participant |
| cIAI:Best Available Therapy | Clinical Cure at FU1 by Previously Failed Treatment Class in EME at FU1 Analysis Set | Comb of Sulf/Trime inc Deriv-Clin. cure(n=0,0,1,0) | 0 Participant |
| cIAI:Best Available Therapy | Clinical Cure at FU1 by Previously Failed Treatment Class in EME at FU1 Analysis Set | Other Antibacterials-Clin. cure (n=0,1,1,0) | 0 Participant |
| cIAI:Best Available Therapy | Clinical Cure at FU1 by Previously Failed Treatment Class in EME at FU1 Analysis Set | Other Aminoglycosides-Clin. cure (n=0,0,0,1) | 0 Participant |
| cIAI:Best Available Therapy | Clinical Cure at FU1 by Previously Failed Treatment Class in EME at FU1 Analysis Set | Carbapenems - Clin. cure (n=0,0,1,1) | 0 Participant |
| cIAI:Best Available Therapy | Clinical Cure at FU1 by Previously Failed Treatment Class in EME at FU1 Analysis Set | Other Antibio. F. Topic. Use-Clin. cure(n=0,0,1,0) | 0 Participant |
| cIAI:Best Available Therapy | Clinical Cure at FU1 by Previously Failed Treatment Class in EME at FU1 Analysis Set | Fluoroquinolones - Clin. cure (n=0,2,5,1) | 0 Participant |
| cIAI:Best Available Therapy | Clinical Cure at FU1 by Previously Failed Treatment Class in EME at FU1 Analysis Set | First-Gen. Cephalosporins-Clin. cure (n=0,0,2,0) | 0 Participant |
| cIAI:CAZ-AVI + Metronidazole | Clinical Cure at FU1 by Previously Failed Treatment Class in EME at FU1 Analysis Set | Fluoroquinolones - Clin. cure (n=0,2,5,1) | 2 Participant |
| cIAI:CAZ-AVI + Metronidazole | Clinical Cure at FU1 by Previously Failed Treatment Class in EME at FU1 Analysis Set | Other Antibacterials-Clin. cure (n=0,1,1,0) | 1 Participant |
| cIAI:CAZ-AVI + Metronidazole | Clinical Cure at FU1 by Previously Failed Treatment Class in EME at FU1 Analysis Set | Imidazole Derivatives - Clin. cure (n=1,3,0,0) | 3 Participant |
| cIAI:CAZ-AVI + Metronidazole | Clinical Cure at FU1 by Previously Failed Treatment Class in EME at FU1 Analysis Set | Carbapenems - Clin. cure (n=0,0,1,1) | 0 Participant |
| cIAI:CAZ-AVI + Metronidazole | Clinical Cure at FU1 by Previously Failed Treatment Class in EME at FU1 Analysis Set | Other Aminoglycosides-Clin. cure (n=0,0,0,1) | 0 Participant |
| cIAI:CAZ-AVI + Metronidazole | Clinical Cure at FU1 by Previously Failed Treatment Class in EME at FU1 Analysis Set | Comb of Sulf/Trime inc Deriv-Clin. cure(n=0,0,1,0) | 0 Participant |
| cIAI:CAZ-AVI + Metronidazole | Clinical Cure at FU1 by Previously Failed Treatment Class in EME at FU1 Analysis Set | Antibiotics - Clin. cure (n=0,1,0,0) | 1 Participant |
| cIAI:CAZ-AVI + Metronidazole | Clinical Cure at FU1 by Previously Failed Treatment Class in EME at FU1 Analysis Set | Penici. With Ext. Spectrum-Clin. cure(n=0,1,0,0) | 1 Participant |
| cIAI:CAZ-AVI + Metronidazole | Clinical Cure at FU1 by Previously Failed Treatment Class in EME at FU1 Analysis Set | Combs Of Peni. Inc B-Lact. Inhib.-Cure(n=1,3,0,2) | 3 Participant |
| cIAI:CAZ-AVI + Metronidazole | Clinical Cure at FU1 by Previously Failed Treatment Class in EME at FU1 Analysis Set | First-Gen. Cephalosporins-Clin. cure (n=0,0,2,0) | 0 Participant |
| cIAI:CAZ-AVI + Metronidazole | Clinical Cure at FU1 by Previously Failed Treatment Class in EME at FU1 Analysis Set | Cortico,Po. Comb W/Antibio.-Clin. cure(n=0,0,1,0) | 0 Participant |
| cIAI:CAZ-AVI + Metronidazole | Clinical Cure at FU1 by Previously Failed Treatment Class in EME at FU1 Analysis Set | Third-Gen.Cephalosporins -Clin. cure(n=2,4,1,2) | 4 Participant |
| cIAI:CAZ-AVI + Metronidazole | Clinical Cure at FU1 by Previously Failed Treatment Class in EME at FU1 Analysis Set | Other Antibio. F. Topic. Use-Clin. cure(n=0,0,1,0) | 0 Participant |
| cUTI:Best Available Therapy | Clinical Cure at FU1 by Previously Failed Treatment Class in EME at FU1 Analysis Set | Fluoroquinolones - Clin. cure (n=0,2,5,1) | 4 Participant |
| cUTI:Best Available Therapy | Clinical Cure at FU1 by Previously Failed Treatment Class in EME at FU1 Analysis Set | Antibiotics - Clin. cure (n=0,1,0,0) | 0 Participant |
| cUTI:Best Available Therapy | Clinical Cure at FU1 by Previously Failed Treatment Class in EME at FU1 Analysis Set | Carbapenems - Clin. cure (n=0,0,1,1) | 1 Participant |
| cUTI:Best Available Therapy | Clinical Cure at FU1 by Previously Failed Treatment Class in EME at FU1 Analysis Set | Comb of Sulf/Trime inc Deriv-Clin. cure(n=0,0,1,0) | 1 Participant |
| cUTI:Best Available Therapy | Clinical Cure at FU1 by Previously Failed Treatment Class in EME at FU1 Analysis Set | Combs Of Peni. Inc B-Lact. Inhib.-Cure(n=1,3,0,2) | 0 Participant |
| cUTI:Best Available Therapy | Clinical Cure at FU1 by Previously Failed Treatment Class in EME at FU1 Analysis Set | Cortico,Po. Comb W/Antibio.-Clin. cure(n=0,0,1,0) | 0 Participant |
| cUTI:Best Available Therapy | Clinical Cure at FU1 by Previously Failed Treatment Class in EME at FU1 Analysis Set | First-Gen. Cephalosporins-Clin. cure (n=0,0,2,0) | 2 Participant |
| cUTI:Best Available Therapy | Clinical Cure at FU1 by Previously Failed Treatment Class in EME at FU1 Analysis Set | Imidazole Derivatives - Clin. cure (n=1,3,0,0) | 0 Participant |
| cUTI:Best Available Therapy | Clinical Cure at FU1 by Previously Failed Treatment Class in EME at FU1 Analysis Set | Other Aminoglycosides-Clin. cure (n=0,0,0,1) | 0 Participant |
| cUTI:Best Available Therapy | Clinical Cure at FU1 by Previously Failed Treatment Class in EME at FU1 Analysis Set | Other Antibacterials-Clin. cure (n=0,1,1,0) | 1 Participant |
| cUTI:Best Available Therapy | Clinical Cure at FU1 by Previously Failed Treatment Class in EME at FU1 Analysis Set | Other Antibio. F. Topic. Use-Clin. cure(n=0,0,1,0) | 1 Participant |
| cUTI:Best Available Therapy | Clinical Cure at FU1 by Previously Failed Treatment Class in EME at FU1 Analysis Set | Penici. With Ext. Spectrum-Clin. cure(n=0,1,0,0) | 0 Participant |
| cUTI:Best Available Therapy | Clinical Cure at FU1 by Previously Failed Treatment Class in EME at FU1 Analysis Set | Third-Gen.Cephalosporins -Clin. cure(n=2,4,1,2) | 0 Participant |
| cUTI:CAZ-AVI | Clinical Cure at FU1 by Previously Failed Treatment Class in EME at FU1 Analysis Set | Other Antibacterials-Clin. cure (n=0,1,1,0) | 0 Participant |
| cUTI:CAZ-AVI | Clinical Cure at FU1 by Previously Failed Treatment Class in EME at FU1 Analysis Set | First-Gen. Cephalosporins-Clin. cure (n=0,0,2,0) | 0 Participant |
| cUTI:CAZ-AVI | Clinical Cure at FU1 by Previously Failed Treatment Class in EME at FU1 Analysis Set | Cortico,Po. Comb W/Antibio.-Clin. cure(n=0,0,1,0) | 0 Participant |
| cUTI:CAZ-AVI | Clinical Cure at FU1 by Previously Failed Treatment Class in EME at FU1 Analysis Set | Antibiotics - Clin. cure (n=0,1,0,0) | 0 Participant |
| cUTI:CAZ-AVI | Clinical Cure at FU1 by Previously Failed Treatment Class in EME at FU1 Analysis Set | Other Antibio. F. Topic. Use-Clin. cure(n=0,0,1,0) | 0 Participant |
| cUTI:CAZ-AVI | Clinical Cure at FU1 by Previously Failed Treatment Class in EME at FU1 Analysis Set | Combs Of Peni. Inc B-Lact. Inhib.-Cure(n=1,3,0,2) | 2 Participant |
| cUTI:CAZ-AVI | Clinical Cure at FU1 by Previously Failed Treatment Class in EME at FU1 Analysis Set | Comb of Sulf/Trime inc Deriv-Clin. cure(n=0,0,1,0) | 0 Participant |
| cUTI:CAZ-AVI | Clinical Cure at FU1 by Previously Failed Treatment Class in EME at FU1 Analysis Set | Third-Gen.Cephalosporins -Clin. cure(n=2,4,1,2) | 2 Participant |
| cUTI:CAZ-AVI | Clinical Cure at FU1 by Previously Failed Treatment Class in EME at FU1 Analysis Set | Penici. With Ext. Spectrum-Clin. cure(n=0,1,0,0) | 0 Participant |
| cUTI:CAZ-AVI | Clinical Cure at FU1 by Previously Failed Treatment Class in EME at FU1 Analysis Set | Other Aminoglycosides-Clin. cure (n=0,0,0,1) | 1 Participant |
| cUTI:CAZ-AVI | Clinical Cure at FU1 by Previously Failed Treatment Class in EME at FU1 Analysis Set | Imidazole Derivatives - Clin. cure (n=1,3,0,0) | 0 Participant |
| cUTI:CAZ-AVI | Clinical Cure at FU1 by Previously Failed Treatment Class in EME at FU1 Analysis Set | Fluoroquinolones - Clin. cure (n=0,2,5,1) | 1 Participant |
| cUTI:CAZ-AVI | Clinical Cure at FU1 by Previously Failed Treatment Class in EME at FU1 Analysis Set | Carbapenems - Clin. cure (n=0,0,1,1) | 1 Participant |
Secondary
Clinical Cure at FU2 by Previously Failed Treatment Class in EME at FU2 Analysis Set
Proportion of patients with clinical cure at FU2 visit by previously failed treatment class in EME at FU2 analysis set. Clinical cure: Complete resolution or significant improvement of signs and symptoms of the index infection such that no further antibacterial therapy (other than those allowed per protocol) is necessary.
Time frame: At FU2, data was only collected for the cUTI Arms: 28-34 calendar days from randomization
Population: Extended microbiologically evaluable at FU2
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| cUTI:Best Available Therapy | Clinical Cure at FU2 by Previously Failed Treatment Class in EME at FU2 Analysis Set | Carbapenems - Clin. cure (n=1,0) | 0 Participant |
| cUTI:Best Available Therapy | Clinical Cure at FU2 by Previously Failed Treatment Class in EME at FU2 Analysis Set | Comb of Sulf/Trime inc Deriv-Clin. cure(n=1,0) | 0 Participant |
| cUTI:Best Available Therapy | Clinical Cure at FU2 by Previously Failed Treatment Class in EME at FU2 Analysis Set | Combs Of Peni. Inc B-Lact. Inhib.-Cure(n=0,2) | 0 Participant |
| cUTI:Best Available Therapy | Clinical Cure at FU2 by Previously Failed Treatment Class in EME at FU2 Analysis Set | Cortico,Po. Comb W/Antibio.-Clin. cure(n=1,0) | 0 Participant |
| cUTI:Best Available Therapy | Clinical Cure at FU2 by Previously Failed Treatment Class in EME at FU2 Analysis Set | First-Gen. Cephalosporins-Clin. cure (n=2,0) | 2 Participant |
| cUTI:Best Available Therapy | Clinical Cure at FU2 by Previously Failed Treatment Class in EME at FU2 Analysis Set | Fluoroquinolones - Clin. cure (n=5,0) | 4 Participant |
| cUTI:Best Available Therapy | Clinical Cure at FU2 by Previously Failed Treatment Class in EME at FU2 Analysis Set | Other Aminoglycosides-Clin. cure (n=0,1) | 0 Participant |
| cUTI:Best Available Therapy | Clinical Cure at FU2 by Previously Failed Treatment Class in EME at FU2 Analysis Set | Other Antibacterials-Clin. cure (n=1,0) | 0 Participant |
| cUTI:Best Available Therapy | Clinical Cure at FU2 by Previously Failed Treatment Class in EME at FU2 Analysis Set | Other Antibio. F. Topic. Use-Clin. cure(n=1,0) | 1 Participant |
| cUTI:Best Available Therapy | Clinical Cure at FU2 by Previously Failed Treatment Class in EME at FU2 Analysis Set | Third-Gen.Cephalosporins -Clin. cure(n=1,1) | 0 Participant |
| cUTI:CAZ-AVI | Clinical Cure at FU2 by Previously Failed Treatment Class in EME at FU2 Analysis Set | Other Antibacterials-Clin. cure (n=1,0) | 0 Participant |
| cUTI:CAZ-AVI | Clinical Cure at FU2 by Previously Failed Treatment Class in EME at FU2 Analysis Set | Carbapenems - Clin. cure (n=1,0) | 0 Participant |
| cUTI:CAZ-AVI | Clinical Cure at FU2 by Previously Failed Treatment Class in EME at FU2 Analysis Set | Fluoroquinolones - Clin. cure (n=5,0) | 0 Participant |
| cUTI:CAZ-AVI | Clinical Cure at FU2 by Previously Failed Treatment Class in EME at FU2 Analysis Set | Comb of Sulf/Trime inc Deriv-Clin. cure(n=1,0) | 0 Participant |
| cUTI:CAZ-AVI | Clinical Cure at FU2 by Previously Failed Treatment Class in EME at FU2 Analysis Set | Third-Gen.Cephalosporins -Clin. cure(n=1,1) | 1 Participant |
| cUTI:CAZ-AVI | Clinical Cure at FU2 by Previously Failed Treatment Class in EME at FU2 Analysis Set | Combs Of Peni. Inc B-Lact. Inhib.-Cure(n=0,2) | 2 Participant |
| cUTI:CAZ-AVI | Clinical Cure at FU2 by Previously Failed Treatment Class in EME at FU2 Analysis Set | Other Aminoglycosides-Clin. cure (n=0,1) | 1 Participant |
| cUTI:CAZ-AVI | Clinical Cure at FU2 by Previously Failed Treatment Class in EME at FU2 Analysis Set | Cortico,Po. Comb W/Antibio.-Clin. cure(n=1,0) | 0 Participant |
| cUTI:CAZ-AVI | Clinical Cure at FU2 by Previously Failed Treatment Class in EME at FU2 Analysis Set | Other Antibio. F. Topic. Use-Clin. cure(n=1,0) | 0 Participant |
| cUTI:CAZ-AVI | Clinical Cure at FU2 by Previously Failed Treatment Class in EME at FU2 Analysis Set | First-Gen. Cephalosporins-Clin. cure (n=2,0) | 0 Participant |
Secondary
Clinical Cure at TOC by Baseline Gram-negative Pathogen in EME at TOC Analysis Set
Proportion of patients with clinical cure at TOC visit by baseline Gram-negative pathogen (\>=10% of frequency in the combined cIAI and cUTI patients) in EME at TOC analysis set. Clinical cure: Complete resolution or significant improvement of signs and symptoms of the index infection such that no further antibacterial therapy (other than those allowed per protocol) is necessary; for cIAI patients no drainage or surgical intervention after 96 hours from randomization is necessary (ie. drainage or surgical intervention up to 96 hours from randomization is permissible).
Time frame: 6-12 days after last infusion of study therapy.Duration of study therapy was 5 to 21 days.
Population: Extended microbiologically evaluable at TOC
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| cIAI:Best Available Therapy | Clinical Cure at TOC by Baseline Gram-negative Pathogen in EME at TOC Analysis Set | K. pneumoniae - Clinical cure (n=2, 3, 59, 53) | 2 Participant |
| cIAI:Best Available Therapy | Clinical Cure at TOC by Baseline Gram-negative Pathogen in EME at TOC Analysis Set | P. aeruginosa - Clinical cure (n=1, 1, 5, 12) | 1 Participant |
| cIAI:Best Available Therapy | Clinical Cure at TOC by Baseline Gram-negative Pathogen in EME at TOC Analysis Set | E. coli - Clinical cure (n=2, 3, 48, 52) | 2 Participant |
| cIAI:CAZ-AVI + Metronidazole | Clinical Cure at TOC by Baseline Gram-negative Pathogen in EME at TOC Analysis Set | K. pneumoniae - Clinical cure (n=2, 3, 59, 53) | 3 Participant |
| cIAI:CAZ-AVI + Metronidazole | Clinical Cure at TOC by Baseline Gram-negative Pathogen in EME at TOC Analysis Set | P. aeruginosa - Clinical cure (n=1, 1, 5, 12) | 1 Participant |
| cIAI:CAZ-AVI + Metronidazole | Clinical Cure at TOC by Baseline Gram-negative Pathogen in EME at TOC Analysis Set | E. coli - Clinical cure (n=2, 3, 48, 52) | 3 Participant |
| cUTI:Best Available Therapy | Clinical Cure at TOC by Baseline Gram-negative Pathogen in EME at TOC Analysis Set | E. coli - Clinical cure (n=2, 3, 48, 52) | 47 Participant |
| cUTI:Best Available Therapy | Clinical Cure at TOC by Baseline Gram-negative Pathogen in EME at TOC Analysis Set | K. pneumoniae - Clinical cure (n=2, 3, 59, 53) | 59 Participant |
| cUTI:Best Available Therapy | Clinical Cure at TOC by Baseline Gram-negative Pathogen in EME at TOC Analysis Set | P. aeruginosa - Clinical cure (n=1, 1, 5, 12) | 5 Participant |
| cUTI:CAZ-AVI | Clinical Cure at TOC by Baseline Gram-negative Pathogen in EME at TOC Analysis Set | K. pneumoniae - Clinical cure (n=2, 3, 59, 53) | 53 Participant |
| cUTI:CAZ-AVI | Clinical Cure at TOC by Baseline Gram-negative Pathogen in EME at TOC Analysis Set | E. coli - Clinical cure (n=2, 3, 48, 52) | 51 Participant |
| cUTI:CAZ-AVI | Clinical Cure at TOC by Baseline Gram-negative Pathogen in EME at TOC Analysis Set | P. aeruginosa - Clinical cure (n=1, 1, 5, 12) | 12 Participant |
Secondary
Clinical Cure at TOC by Baseline Gram-negative Pathogen in mMITT Analysis Set
Proportion of patients with clinical cure at TOC visit by baseline pathogen (\>=10% of frequency in the combined cIAI and cUTI patients) in the mMITT analysis set. Clinical cure: Complete resolution or significant improvement of signs and symptoms of the index infection such that no further antibacterial therapy (other than those allowed per protocol) is necessary; for cIAI patients no drainage or surgical intervention after 96 hours from randomization is necessary (ie. drainage or surgical intervention up to 96 hours from randomization is permissible).
Time frame: 6-12 days after last infusion of study therapy.Duration of study therapy was 5 to 21 days.
Population: Microbiological modified intent to treat
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| cIAI:Best Available Therapy | Clinical Cure at TOC by Baseline Gram-negative Pathogen in mMITT Analysis Set | E. coli - Clinical cure (n=6, 4, 57, 59) | 2 Participant |
| cIAI:Best Available Therapy | Clinical Cure at TOC by Baseline Gram-negative Pathogen in mMITT Analysis Set | K. pneumoniae - Clinical cure (n=3, 5, 65, 55) | 2 Participant |
| cIAI:Best Available Therapy | Clinical Cure at TOC by Baseline Gram-negative Pathogen in mMITT Analysis Set | P. aeruginosa - clinical cure (n=1, 1, 5, 14) | 1 Participant |
| cIAI:CAZ-AVI + Metronidazole | Clinical Cure at TOC by Baseline Gram-negative Pathogen in mMITT Analysis Set | K. pneumoniae - Clinical cure (n=3, 5, 65, 55) | 3 Participant |
| cIAI:CAZ-AVI + Metronidazole | Clinical Cure at TOC by Baseline Gram-negative Pathogen in mMITT Analysis Set | E. coli - Clinical cure (n=6, 4, 57, 59) | 3 Participant |
| cIAI:CAZ-AVI + Metronidazole | Clinical Cure at TOC by Baseline Gram-negative Pathogen in mMITT Analysis Set | P. aeruginosa - clinical cure (n=1, 1, 5, 14) | 1 Participant |
| cUTI:Best Available Therapy | Clinical Cure at TOC by Baseline Gram-negative Pathogen in mMITT Analysis Set | E. coli - Clinical cure (n=6, 4, 57, 59) | 54 Participant |
| cUTI:Best Available Therapy | Clinical Cure at TOC by Baseline Gram-negative Pathogen in mMITT Analysis Set | K. pneumoniae - Clinical cure (n=3, 5, 65, 55) | 61 Participant |
| cUTI:Best Available Therapy | Clinical Cure at TOC by Baseline Gram-negative Pathogen in mMITT Analysis Set | P. aeruginosa - clinical cure (n=1, 1, 5, 14) | 5 Participant |
| cUTI:CAZ-AVI | Clinical Cure at TOC by Baseline Gram-negative Pathogen in mMITT Analysis Set | K. pneumoniae - Clinical cure (n=3, 5, 65, 55) | 54 Participant |
| cUTI:CAZ-AVI | Clinical Cure at TOC by Baseline Gram-negative Pathogen in mMITT Analysis Set | P. aeruginosa - clinical cure (n=1, 1, 5, 14) | 12 Participant |
| cUTI:CAZ-AVI | Clinical Cure at TOC by Baseline Gram-negative Pathogen in mMITT Analysis Set | E. coli - Clinical cure (n=6, 4, 57, 59) | 53 Participant |
Secondary
Clinical Cure at TOC by Previously Failed Treatment Class in EME at TOC Analysis Set
Proportion of patients with clinical cure at TOC visit by previously failed treatment class in EME at TOC analysis set. Clinical cure: Complete resolution or significant improvement of signs and symptoms of the index infection such that no further antibacterial therapy (other than those allowed per protocol) is necessary; for cIAI patients no drainage or surgical intervention after 96 hours from randomization is necessary (ie. drainage or surgical intervention up to 96 hours from randomization is permissible).
Time frame: 6-12 days after last infusion of study therapy. Duration of study therapy was 5 to 21 days.
Population: Extended microbiologically evaluable at TOC
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| cIAI:Best Available Therapy | Clinical Cure at TOC by Previously Failed Treatment Class in EME at TOC Analysis Set | Antibiotics - Clin. cure (n=0,1,0,0) | 0 Participant |
| cIAI:Best Available Therapy | Clinical Cure at TOC by Previously Failed Treatment Class in EME at TOC Analysis Set | Carbapenems - Clin. cure (n=0,0,1,1) | 0 Participant |
| cIAI:Best Available Therapy | Clinical Cure at TOC by Previously Failed Treatment Class in EME at TOC Analysis Set | Comb of Sulf/Trime inc Deriv-Clin. cure(n=0,0,2,0) | 0 Participant |
| cIAI:Best Available Therapy | Clinical Cure at TOC by Previously Failed Treatment Class in EME at TOC Analysis Set | Combs Of Peni. Inc B-Lact. Inhib.-Cure(n=1,3,0,2) | 1 Participant |
| cIAI:Best Available Therapy | Clinical Cure at TOC by Previously Failed Treatment Class in EME at TOC Analysis Set | Cortico,Po. Comb W/Antibio.-Clin. cure(n=0,0,1,0) | 0 Participant |
| cIAI:Best Available Therapy | Clinical Cure at TOC by Previously Failed Treatment Class in EME at TOC Analysis Set | First-Gen. Cephalosporins-Clin. cure (n=0,0,2,0) | 0 Participant |
| cIAI:Best Available Therapy | Clinical Cure at TOC by Previously Failed Treatment Class in EME at TOC Analysis Set | Fluoroquinolones - Clin. cure (n=0,2,5,1) | 0 Participant |
| cIAI:Best Available Therapy | Clinical Cure at TOC by Previously Failed Treatment Class in EME at TOC Analysis Set | Imidazole Derivatives - Clin. cure (n=1,3,0,0) | 1 Participant |
| cIAI:Best Available Therapy | Clinical Cure at TOC by Previously Failed Treatment Class in EME at TOC Analysis Set | Other Aminoglycosides-Clin. cure (n=0,0,0,1) | 0 Participant |
| cIAI:Best Available Therapy | Clinical Cure at TOC by Previously Failed Treatment Class in EME at TOC Analysis Set | Other Antibacterials-Clin. cure (n=0,1,1,0) | 0 Participant |
| cIAI:Best Available Therapy | Clinical Cure at TOC by Previously Failed Treatment Class in EME at TOC Analysis Set | Other Antibio. F. Topic. Use-Clin. cure(n=0,0,1,0) | 0 Participant |
| cIAI:Best Available Therapy | Clinical Cure at TOC by Previously Failed Treatment Class in EME at TOC Analysis Set | Penici. With Ext. Spectrum-Clin. cure(n=0,1,0,0) | 0 Participant |
| cIAI:Best Available Therapy | Clinical Cure at TOC by Previously Failed Treatment Class in EME at TOC Analysis Set | Third-Gen.Cephalosporins -Clin. cure(n=2,4,2,2) | 2 Participant |
| cIAI:CAZ-AVI + Metronidazole | Clinical Cure at TOC by Previously Failed Treatment Class in EME at TOC Analysis Set | Combs Of Peni. Inc B-Lact. Inhib.-Cure(n=1,3,0,2) | 3 Participant |
| cIAI:CAZ-AVI + Metronidazole | Clinical Cure at TOC by Previously Failed Treatment Class in EME at TOC Analysis Set | Third-Gen.Cephalosporins -Clin. cure(n=2,4,2,2) | 4 Participant |
| cIAI:CAZ-AVI + Metronidazole | Clinical Cure at TOC by Previously Failed Treatment Class in EME at TOC Analysis Set | Other Antibio. F. Topic. Use-Clin. cure(n=0,0,1,0) | 0 Participant |
| cIAI:CAZ-AVI + Metronidazole | Clinical Cure at TOC by Previously Failed Treatment Class in EME at TOC Analysis Set | Imidazole Derivatives - Clin. cure (n=1,3,0,0) | 3 Participant |
| cIAI:CAZ-AVI + Metronidazole | Clinical Cure at TOC by Previously Failed Treatment Class in EME at TOC Analysis Set | Comb of Sulf/Trime inc Deriv-Clin. cure(n=0,0,2,0) | 0 Participant |
| cIAI:CAZ-AVI + Metronidazole | Clinical Cure at TOC by Previously Failed Treatment Class in EME at TOC Analysis Set | Antibiotics - Clin. cure (n=0,1,0,0) | 1 Participant |
| cIAI:CAZ-AVI + Metronidazole | Clinical Cure at TOC by Previously Failed Treatment Class in EME at TOC Analysis Set | Other Antibacterials-Clin. cure (n=0,1,1,0) | 1 Participant |
| cIAI:CAZ-AVI + Metronidazole | Clinical Cure at TOC by Previously Failed Treatment Class in EME at TOC Analysis Set | Other Aminoglycosides-Clin. cure (n=0,0,0,1) | 0 Participant |
| cIAI:CAZ-AVI + Metronidazole | Clinical Cure at TOC by Previously Failed Treatment Class in EME at TOC Analysis Set | First-Gen. Cephalosporins-Clin. cure (n=0,0,2,0) | 0 Participant |
| cIAI:CAZ-AVI + Metronidazole | Clinical Cure at TOC by Previously Failed Treatment Class in EME at TOC Analysis Set | Cortico,Po. Comb W/Antibio.-Clin. cure(n=0,0,1,0) | 0 Participant |
| cIAI:CAZ-AVI + Metronidazole | Clinical Cure at TOC by Previously Failed Treatment Class in EME at TOC Analysis Set | Carbapenems - Clin. cure (n=0,0,1,1) | 0 Participant |
| cIAI:CAZ-AVI + Metronidazole | Clinical Cure at TOC by Previously Failed Treatment Class in EME at TOC Analysis Set | Penici. With Ext. Spectrum-Clin. cure(n=0,1,0,0) | 1 Participant |
| cIAI:CAZ-AVI + Metronidazole | Clinical Cure at TOC by Previously Failed Treatment Class in EME at TOC Analysis Set | Fluoroquinolones - Clin. cure (n=0,2,5,1) | 2 Participant |
| cUTI:Best Available Therapy | Clinical Cure at TOC by Previously Failed Treatment Class in EME at TOC Analysis Set | Other Antibio. F. Topic. Use-Clin. cure(n=0,0,1,0) | 1 Participant |
| cUTI:Best Available Therapy | Clinical Cure at TOC by Previously Failed Treatment Class in EME at TOC Analysis Set | Combs Of Peni. Inc B-Lact. Inhib.-Cure(n=1,3,0,2) | 0 Participant |
| cUTI:Best Available Therapy | Clinical Cure at TOC by Previously Failed Treatment Class in EME at TOC Analysis Set | Cortico,Po. Comb W/Antibio.-Clin. cure(n=0,0,1,0) | 1 Participant |
| cUTI:Best Available Therapy | Clinical Cure at TOC by Previously Failed Treatment Class in EME at TOC Analysis Set | Third-Gen.Cephalosporins -Clin. cure(n=2,4,2,2) | 2 Participant |
| cUTI:Best Available Therapy | Clinical Cure at TOC by Previously Failed Treatment Class in EME at TOC Analysis Set | First-Gen. Cephalosporins-Clin. cure (n=0,0,2,0) | 2 Participant |
| cUTI:Best Available Therapy | Clinical Cure at TOC by Previously Failed Treatment Class in EME at TOC Analysis Set | Fluoroquinolones - Clin. cure (n=0,2,5,1) | 5 Participant |
| cUTI:Best Available Therapy | Clinical Cure at TOC by Previously Failed Treatment Class in EME at TOC Analysis Set | Penici. With Ext. Spectrum-Clin. cure(n=0,1,0,0) | 0 Participant |
| cUTI:Best Available Therapy | Clinical Cure at TOC by Previously Failed Treatment Class in EME at TOC Analysis Set | Imidazole Derivatives - Clin. cure (n=1,3,0,0) | 0 Participant |
| cUTI:Best Available Therapy | Clinical Cure at TOC by Previously Failed Treatment Class in EME at TOC Analysis Set | Other Aminoglycosides-Clin. cure (n=0,0,0,1) | 0 Participant |
| cUTI:Best Available Therapy | Clinical Cure at TOC by Previously Failed Treatment Class in EME at TOC Analysis Set | Other Antibacterials-Clin. cure (n=0,1,1,0) | 1 Participant |
| cUTI:Best Available Therapy | Clinical Cure at TOC by Previously Failed Treatment Class in EME at TOC Analysis Set | Antibiotics - Clin. cure (n=0,1,0,0) | 0 Participant |
| cUTI:Best Available Therapy | Clinical Cure at TOC by Previously Failed Treatment Class in EME at TOC Analysis Set | Carbapenems - Clin. cure (n=0,0,1,1) | 1 Participant |
| cUTI:Best Available Therapy | Clinical Cure at TOC by Previously Failed Treatment Class in EME at TOC Analysis Set | Comb of Sulf/Trime inc Deriv-Clin. cure(n=0,0,2,0) | 2 Participant |
| cUTI:CAZ-AVI | Clinical Cure at TOC by Previously Failed Treatment Class in EME at TOC Analysis Set | Other Antibacterials-Clin. cure (n=0,1,1,0) | 0 Participant |
| cUTI:CAZ-AVI | Clinical Cure at TOC by Previously Failed Treatment Class in EME at TOC Analysis Set | Imidazole Derivatives - Clin. cure (n=1,3,0,0) | 0 Participant |
| cUTI:CAZ-AVI | Clinical Cure at TOC by Previously Failed Treatment Class in EME at TOC Analysis Set | Combs Of Peni. Inc B-Lact. Inhib.-Cure(n=1,3,0,2) | 2 Participant |
| cUTI:CAZ-AVI | Clinical Cure at TOC by Previously Failed Treatment Class in EME at TOC Analysis Set | Antibiotics - Clin. cure (n=0,1,0,0) | 0 Participant |
| cUTI:CAZ-AVI | Clinical Cure at TOC by Previously Failed Treatment Class in EME at TOC Analysis Set | Fluoroquinolones - Clin. cure (n=0,2,5,1) | 1 Participant |
| cUTI:CAZ-AVI | Clinical Cure at TOC by Previously Failed Treatment Class in EME at TOC Analysis Set | First-Gen. Cephalosporins-Clin. cure (n=0,0,2,0) | 0 Participant |
| cUTI:CAZ-AVI | Clinical Cure at TOC by Previously Failed Treatment Class in EME at TOC Analysis Set | Comb of Sulf/Trime inc Deriv-Clin. cure(n=0,0,2,0) | 0 Participant |
| cUTI:CAZ-AVI | Clinical Cure at TOC by Previously Failed Treatment Class in EME at TOC Analysis Set | Carbapenems - Clin. cure (n=0,0,1,1) | 1 Participant |
| cUTI:CAZ-AVI | Clinical Cure at TOC by Previously Failed Treatment Class in EME at TOC Analysis Set | Cortico,Po. Comb W/Antibio.-Clin. cure(n=0,0,1,0) | 0 Participant |
| cUTI:CAZ-AVI | Clinical Cure at TOC by Previously Failed Treatment Class in EME at TOC Analysis Set | Other Aminoglycosides-Clin. cure (n=0,0,0,1) | 1 Participant |
| cUTI:CAZ-AVI | Clinical Cure at TOC by Previously Failed Treatment Class in EME at TOC Analysis Set | Third-Gen.Cephalosporins -Clin. cure(n=2,4,2,2) | 2 Participant |
| cUTI:CAZ-AVI | Clinical Cure at TOC by Previously Failed Treatment Class in EME at TOC Analysis Set | Penici. With Ext. Spectrum-Clin. cure(n=0,1,0,0) | 0 Participant |
| cUTI:CAZ-AVI | Clinical Cure at TOC by Previously Failed Treatment Class in EME at TOC Analysis Set | Other Antibio. F. Topic. Use-Clin. cure(n=0,0,1,0) | 0 Participant |
Secondary
Clinical Cure at TOC by Previously Failed Treatment Class in mMITT Analysis Set
Proportion of patients with clinical cure at TOC visit by previously failed treatment class in the mMITT analysis set. Clinical cure: Complete resolution or significant improvement of signs and symptoms of the index infection such that no further antibacterial therapy (other than those allowed per protocol) is necessary; for cIAI patients no drainage or surgical intervention after 96 hours from randomization is necessary (ie. drainage or surgical intervention up to 96 hours from randomization is permissible).
Time frame: 6-12 days after last infusion of study therapy. Duration of study therapy was 5 to 21 days.
Population: Microbiological modified intent to treat
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| cIAI:Best Available Therapy | Clinical Cure at TOC by Previously Failed Treatment Class in mMITT Analysis Set | At least 1 failed - Clin. cure (n=4,7,12,7) | 3 Participant |
| cIAI:Best Available Therapy | Clinical Cure at TOC by Previously Failed Treatment Class in mMITT Analysis Set | Other Antibacterials-Clin. cure (n=0,1,1,0) | 0 Participant |
| cIAI:Best Available Therapy | Clinical Cure at TOC by Previously Failed Treatment Class in mMITT Analysis Set | Glycopeptide Antibacterials-Clin. cure (n=1,0,0,0) | 0 Participant |
| cIAI:Best Available Therapy | Clinical Cure at TOC by Previously Failed Treatment Class in mMITT Analysis Set | Carbapenems - Clin. cure (n=1,0,1,2) | 0 Participant |
| cIAI:Best Available Therapy | Clinical Cure at TOC by Previously Failed Treatment Class in mMITT Analysis Set | Imidazole Derivatives - Clin. cure (n=2,3,0,0) | 1 Participant |
| cIAI:Best Available Therapy | Clinical Cure at TOC by Previously Failed Treatment Class in mMITT Analysis Set | Other Aminoglycosides-Clin. cure (n=0,0,1,1) | 0 Participant |
| cIAI:Best Available Therapy | Clinical Cure at TOC by Previously Failed Treatment Class in mMITT Analysis Set | Comb of Sulf/Trime inc Deriv-Clin. cure(n=0,0,2,0) | 0 Participant |
| cIAI:Best Available Therapy | Clinical Cure at TOC by Previously Failed Treatment Class in mMITT Analysis Set | Antibiotics - Clin. cure (n=0,1,0,0) | 0 Participant |
| cIAI:Best Available Therapy | Clinical Cure at TOC by Previously Failed Treatment Class in mMITT Analysis Set | Penici. With Ext. Spectrum-Clin. cure(n=0,1,0,0) | 0 Participant |
| cIAI:Best Available Therapy | Clinical Cure at TOC by Previously Failed Treatment Class in mMITT Analysis Set | Combs Of Peni. Inc B-Lact. Inhib.-Cure(n=1,3,0,2) | 1 Participant |
| cIAI:Best Available Therapy | Clinical Cure at TOC by Previously Failed Treatment Class in mMITT Analysis Set | Cortico,Po. Comb W/Antibio.-Clin. cure(n=0,0,1,0) | 0 Participant |
| cIAI:Best Available Therapy | Clinical Cure at TOC by Previously Failed Treatment Class in mMITT Analysis Set | Other Antibio. F. Topic. Use-Clin. cure(n=0,0,1,0) | 0 Participant |
| cIAI:Best Available Therapy | Clinical Cure at TOC by Previously Failed Treatment Class in mMITT Analysis Set | First-Gen. Cephalosporins-Clin. cure (n=0,0,2,0) | 0 Participant |
| cIAI:Best Available Therapy | Clinical Cure at TOC by Previously Failed Treatment Class in mMITT Analysis Set | Third-Gen.Cephalosporins -Clin. cure(n=2,4,3,2) | 2 Participant |
| cIAI:Best Available Therapy | Clinical Cure at TOC by Previously Failed Treatment Class in mMITT Analysis Set | Fluoroquinolones - Clin. cure (n=1,2,7,1) | 0 Participant |
| cIAI:CAZ-AVI + Metronidazole | Clinical Cure at TOC by Previously Failed Treatment Class in mMITT Analysis Set | Fluoroquinolones - Clin. cure (n=1,2,7,1) | 2 Participant |
| cIAI:CAZ-AVI + Metronidazole | Clinical Cure at TOC by Previously Failed Treatment Class in mMITT Analysis Set | Other Antibacterials-Clin. cure (n=0,1,1,0) | 1 Participant |
| cIAI:CAZ-AVI + Metronidazole | Clinical Cure at TOC by Previously Failed Treatment Class in mMITT Analysis Set | Combs Of Peni. Inc B-Lact. Inhib.-Cure(n=1,3,0,2) | 3 Participant |
| cIAI:CAZ-AVI + Metronidazole | Clinical Cure at TOC by Previously Failed Treatment Class in mMITT Analysis Set | Glycopeptide Antibacterials-Clin. cure (n=1,0,0,0) | 0 Participant |
| cIAI:CAZ-AVI + Metronidazole | Clinical Cure at TOC by Previously Failed Treatment Class in mMITT Analysis Set | Antibiotics - Clin. cure (n=0,1,0,0) | 1 Participant |
| cIAI:CAZ-AVI + Metronidazole | Clinical Cure at TOC by Previously Failed Treatment Class in mMITT Analysis Set | Other Aminoglycosides-Clin. cure (n=0,0,1,1) | 0 Participant |
| cIAI:CAZ-AVI + Metronidazole | Clinical Cure at TOC by Previously Failed Treatment Class in mMITT Analysis Set | Other Antibio. F. Topic. Use-Clin. cure(n=0,0,1,0) | 0 Participant |
| cIAI:CAZ-AVI + Metronidazole | Clinical Cure at TOC by Previously Failed Treatment Class in mMITT Analysis Set | Imidazole Derivatives - Clin. cure (n=2,3,0,0) | 3 Participant |
| cIAI:CAZ-AVI + Metronidazole | Clinical Cure at TOC by Previously Failed Treatment Class in mMITT Analysis Set | Carbapenems - Clin. cure (n=1,0,1,2) | 0 Participant |
| cIAI:CAZ-AVI + Metronidazole | Clinical Cure at TOC by Previously Failed Treatment Class in mMITT Analysis Set | First-Gen. Cephalosporins-Clin. cure (n=0,0,2,0) | 0 Participant |
| cIAI:CAZ-AVI + Metronidazole | Clinical Cure at TOC by Previously Failed Treatment Class in mMITT Analysis Set | Third-Gen.Cephalosporins -Clin. cure(n=2,4,3,2) | 4 Participant |
| cIAI:CAZ-AVI + Metronidazole | Clinical Cure at TOC by Previously Failed Treatment Class in mMITT Analysis Set | Penici. With Ext. Spectrum-Clin. cure(n=0,1,0,0) | 1 Participant |
| cIAI:CAZ-AVI + Metronidazole | Clinical Cure at TOC by Previously Failed Treatment Class in mMITT Analysis Set | Cortico,Po. Comb W/Antibio.-Clin. cure(n=0,0,1,0) | 0 Participant |
| cIAI:CAZ-AVI + Metronidazole | Clinical Cure at TOC by Previously Failed Treatment Class in mMITT Analysis Set | Comb of Sulf/Trime inc Deriv-Clin. cure(n=0,0,2,0) | 0 Participant |
| cIAI:CAZ-AVI + Metronidazole | Clinical Cure at TOC by Previously Failed Treatment Class in mMITT Analysis Set | At least 1 failed - Clin. cure (n=4,7,12,7) | 7 Participant |
| cUTI:Best Available Therapy | Clinical Cure at TOC by Previously Failed Treatment Class in mMITT Analysis Set | Fluoroquinolones - Clin. cure (n=1,2,7,1) | 7 Participant |
| cUTI:Best Available Therapy | Clinical Cure at TOC by Previously Failed Treatment Class in mMITT Analysis Set | At least 1 failed - Clin. cure (n=4,7,12,7) | 12 Participant |
| cUTI:Best Available Therapy | Clinical Cure at TOC by Previously Failed Treatment Class in mMITT Analysis Set | Antibiotics - Clin. cure (n=0,1,0,0) | 0 Participant |
| cUTI:Best Available Therapy | Clinical Cure at TOC by Previously Failed Treatment Class in mMITT Analysis Set | Carbapenems - Clin. cure (n=1,0,1,2) | 1 Participant |
| cUTI:Best Available Therapy | Clinical Cure at TOC by Previously Failed Treatment Class in mMITT Analysis Set | Comb of Sulf/Trime inc Deriv-Clin. cure(n=0,0,2,0) | 2 Participant |
| cUTI:Best Available Therapy | Clinical Cure at TOC by Previously Failed Treatment Class in mMITT Analysis Set | Combs Of Peni. Inc B-Lact. Inhib.-Cure(n=1,3,0,2) | 0 Participant |
| cUTI:Best Available Therapy | Clinical Cure at TOC by Previously Failed Treatment Class in mMITT Analysis Set | Cortico,Po. Comb W/Antibio.-Clin. cure(n=0,0,1,0) | 1 Participant |
| cUTI:Best Available Therapy | Clinical Cure at TOC by Previously Failed Treatment Class in mMITT Analysis Set | First-Gen. Cephalosporins-Clin. cure (n=0,0,2,0) | 2 Participant |
| cUTI:Best Available Therapy | Clinical Cure at TOC by Previously Failed Treatment Class in mMITT Analysis Set | Glycopeptide Antibacterials-Clin. cure (n=1,0,0,0) | 0 Participant |
| cUTI:Best Available Therapy | Clinical Cure at TOC by Previously Failed Treatment Class in mMITT Analysis Set | Imidazole Derivatives - Clin. cure (n=2,3,0,0) | 0 Participant |
| cUTI:Best Available Therapy | Clinical Cure at TOC by Previously Failed Treatment Class in mMITT Analysis Set | Other Aminoglycosides-Clin. cure (n=0,0,1,1) | 1 Participant |
| cUTI:Best Available Therapy | Clinical Cure at TOC by Previously Failed Treatment Class in mMITT Analysis Set | Other Antibacterials-Clin. cure (n=0,1,1,0) | 1 Participant |
| cUTI:Best Available Therapy | Clinical Cure at TOC by Previously Failed Treatment Class in mMITT Analysis Set | Other Antibio. F. Topic. Use-Clin. cure(n=0,0,1,0) | 1 Participant |
| cUTI:Best Available Therapy | Clinical Cure at TOC by Previously Failed Treatment Class in mMITT Analysis Set | Penici. With Ext. Spectrum-Clin. cure(n=0,1,0,0) | 0 Participant |
| cUTI:Best Available Therapy | Clinical Cure at TOC by Previously Failed Treatment Class in mMITT Analysis Set | Third-Gen.Cephalosporins -Clin. cure(n=2,4,3,2) | 3 Participant |
| cUTI:CAZ-AVI | Clinical Cure at TOC by Previously Failed Treatment Class in mMITT Analysis Set | First-Gen. Cephalosporins-Clin. cure (n=0,0,2,0) | 0 Participant |
| cUTI:CAZ-AVI | Clinical Cure at TOC by Previously Failed Treatment Class in mMITT Analysis Set | Antibiotics - Clin. cure (n=0,1,0,0) | 0 Participant |
| cUTI:CAZ-AVI | Clinical Cure at TOC by Previously Failed Treatment Class in mMITT Analysis Set | Other Antibacterials-Clin. cure (n=0,1,1,0) | 0 Participant |
| cUTI:CAZ-AVI | Clinical Cure at TOC by Previously Failed Treatment Class in mMITT Analysis Set | Cortico,Po. Comb W/Antibio.-Clin. cure(n=0,0,1,0) | 0 Participant |
| cUTI:CAZ-AVI | Clinical Cure at TOC by Previously Failed Treatment Class in mMITT Analysis Set | Combs Of Peni. Inc B-Lact. Inhib.-Cure(n=1,3,0,2) | 2 Participant |
| cUTI:CAZ-AVI | Clinical Cure at TOC by Previously Failed Treatment Class in mMITT Analysis Set | At least 1 failed - Clin. cure (n=4,7,12,7) | 6 Participant |
| cUTI:CAZ-AVI | Clinical Cure at TOC by Previously Failed Treatment Class in mMITT Analysis Set | Other Antibio. F. Topic. Use-Clin. cure(n=0,0,1,0) | 0 Participant |
| cUTI:CAZ-AVI | Clinical Cure at TOC by Previously Failed Treatment Class in mMITT Analysis Set | Comb of Sulf/Trime inc Deriv-Clin. cure(n=0,0,2,0) | 0 Participant |
| cUTI:CAZ-AVI | Clinical Cure at TOC by Previously Failed Treatment Class in mMITT Analysis Set | Carbapenems - Clin. cure (n=1,0,1,2) | 1 Participant |
| cUTI:CAZ-AVI | Clinical Cure at TOC by Previously Failed Treatment Class in mMITT Analysis Set | Third-Gen.Cephalosporins -Clin. cure(n=2,4,3,2) | 2 Participant |
| cUTI:CAZ-AVI | Clinical Cure at TOC by Previously Failed Treatment Class in mMITT Analysis Set | Imidazole Derivatives - Clin. cure (n=2,3,0,0) | 0 Participant |
| cUTI:CAZ-AVI | Clinical Cure at TOC by Previously Failed Treatment Class in mMITT Analysis Set | Glycopeptide Antibacterials-Clin. cure (n=1,0,0,0) | 0 Participant |
| cUTI:CAZ-AVI | Clinical Cure at TOC by Previously Failed Treatment Class in mMITT Analysis Set | Penici. With Ext. Spectrum-Clin. cure(n=0,1,0,0) | 0 Participant |
| cUTI:CAZ-AVI | Clinical Cure at TOC by Previously Failed Treatment Class in mMITT Analysis Set | Other Aminoglycosides-Clin. cure (n=0,0,1,1) | 1 Participant |
| cUTI:CAZ-AVI | Clinical Cure at TOC by Previously Failed Treatment Class in mMITT Analysis Set | Fluoroquinolones - Clin. cure (n=1,2,7,1) | 1 Participant |
Secondary
Clinical Response at End of Treatment (EOT) in mMITT Analysis Set.
Proportion of patients with clinical cure at the EOT visit in the mMITT analysis set. Clinical cure: Complete resolution or significant improvement of signs and symptoms of the index infection such that no further antibacterial therapy (other than those allowed per protocol) is necessary; for cIAI patients no drainage or surgical intervention after 96 hours from randomization is necessary (ie. drainage or surgical intervention up to 96 hours from randomization is permissible).
Time frame: 28 hours after completion of last infusion of study therapy. Duration of study therapy was 5 to 21 days.
Population: Microbiological modified intent to treat
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| cIAI:Best Available Therapy | Clinical Response at End of Treatment (EOT) in mMITT Analysis Set. | Clinical failure | 0 Participant |
| cIAI:Best Available Therapy | Clinical Response at End of Treatment (EOT) in mMITT Analysis Set. | Indeterminate | 5 Participant |
| cIAI:Best Available Therapy | Clinical Response at End of Treatment (EOT) in mMITT Analysis Set. | Clinical cure | 6 Participant |
| cIAI:CAZ-AVI + Metronidazole | Clinical Response at End of Treatment (EOT) in mMITT Analysis Set. | Clinical failure | 0 Participant |
| cIAI:CAZ-AVI + Metronidazole | Clinical Response at End of Treatment (EOT) in mMITT Analysis Set. | Clinical cure | 9 Participant |
| cIAI:CAZ-AVI + Metronidazole | Clinical Response at End of Treatment (EOT) in mMITT Analysis Set. | Indeterminate | 1 Participant |
| cUTI:Best Available Therapy | Clinical Response at End of Treatment (EOT) in mMITT Analysis Set. | Clinical failure | 0 Participant |
| cUTI:Best Available Therapy | Clinical Response at End of Treatment (EOT) in mMITT Analysis Set. | Indeterminate | 1 Participant |
| cUTI:Best Available Therapy | Clinical Response at End of Treatment (EOT) in mMITT Analysis Set. | Clinical cure | 136 Participant |
| cUTI:CAZ-AVI | Clinical Response at End of Treatment (EOT) in mMITT Analysis Set. | Clinical failure | 0 Participant |
| cUTI:CAZ-AVI | Clinical Response at End of Treatment (EOT) in mMITT Analysis Set. | Clinical cure | 142 Participant |
| cUTI:CAZ-AVI | Clinical Response at End of Treatment (EOT) in mMITT Analysis Set. | Indeterminate | 2 Participant |
Secondary
Clinical Response at EOT in Extended Microbiologically Evaluable (EME) at EOT Analysis Set.
Proportion of patients with clinical cure at the EOT visit in the EME at EOT analysis set. Clinical cure: Complete resolution or significant improvement of signs and symptoms of the index infection such that no further antibacterial therapy (other than those allowed per protocol) is necessary; for cIAI patients no drainage or surgical intervention after 96 hours from randomization is necessary (ie. drainage or surgical intervention up to 96 hours from randomization is permissible).
Time frame: 28 hours after completion of last infusion of study therapy. Duration of study therapy was 5 to 21 days.
Population: Extended Microbiological Evaluable at EOT analysis set.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| cIAI:Best Available Therapy | Clinical Response at EOT in Extended Microbiologically Evaluable (EME) at EOT Analysis Set. | Clinical cure | 5 Participant |
| cIAI:Best Available Therapy | Clinical Response at EOT in Extended Microbiologically Evaluable (EME) at EOT Analysis Set. | Clinical failure | 0 Participant |
| cIAI:CAZ-AVI + Metronidazole | Clinical Response at EOT in Extended Microbiologically Evaluable (EME) at EOT Analysis Set. | Clinical failure | 0 Participant |
| cIAI:CAZ-AVI + Metronidazole | Clinical Response at EOT in Extended Microbiologically Evaluable (EME) at EOT Analysis Set. | Clinical cure | 9 Participant |
| cUTI:Best Available Therapy | Clinical Response at EOT in Extended Microbiologically Evaluable (EME) at EOT Analysis Set. | Clinical cure | 127 Participant |
| cUTI:Best Available Therapy | Clinical Response at EOT in Extended Microbiologically Evaluable (EME) at EOT Analysis Set. | Clinical failure | 0 Participant |
| cUTI:CAZ-AVI | Clinical Response at EOT in Extended Microbiologically Evaluable (EME) at EOT Analysis Set. | Clinical cure | 134 Participant |
| cUTI:CAZ-AVI | Clinical Response at EOT in Extended Microbiologically Evaluable (EME) at EOT Analysis Set. | Clinical failure | 0 Participant |
Secondary
Clinical Response at Follow-up 1 (FU1) in mMITT Analysis Set
Proportion of patients with clinical cure at the FU1 visit in the mMITT analysis set. Clinical cure: Complete resolution or significant improvement of signs and symptoms of the index infection such that no further antibacterial therapy (other than those allowed per protocol) is necessary; for cIAI patients no drainage or surgical intervention after 96 hours from randomization is necessary (ie. drainage or surgical intervention up to 96 hours from randomization is permissible).
Time frame: cIAI: 27-37 calendar days from randomization/cUTI: 20-27 calendar days from randomization
Population: Microbiological modified intent to treat
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| cIAI:Best Available Therapy | Clinical Response at Follow-up 1 (FU1) in mMITT Analysis Set | Indeterminate | 5 Participant |
| cIAI:Best Available Therapy | Clinical Response at Follow-up 1 (FU1) in mMITT Analysis Set | Clinical failure | 0 Participant |
| cIAI:Best Available Therapy | Clinical Response at Follow-up 1 (FU1) in mMITT Analysis Set | Clinical cure | 6 Participant |
| cIAI:CAZ-AVI + Metronidazole | Clinical Response at Follow-up 1 (FU1) in mMITT Analysis Set | Indeterminate | 2 Participant |
| cIAI:CAZ-AVI + Metronidazole | Clinical Response at Follow-up 1 (FU1) in mMITT Analysis Set | Clinical cure | 8 Participant |
| cIAI:CAZ-AVI + Metronidazole | Clinical Response at Follow-up 1 (FU1) in mMITT Analysis Set | Clinical failure | 0 Participant |
| cUTI:Best Available Therapy | Clinical Response at Follow-up 1 (FU1) in mMITT Analysis Set | Clinical failure | 8 Participant |
| cUTI:Best Available Therapy | Clinical Response at Follow-up 1 (FU1) in mMITT Analysis Set | Indeterminate | 8 Participant |
| cUTI:Best Available Therapy | Clinical Response at Follow-up 1 (FU1) in mMITT Analysis Set | Clinical cure | 121 Participant |
| cUTI:CAZ-AVI | Clinical Response at Follow-up 1 (FU1) in mMITT Analysis Set | Indeterminate | 12 Participant |
| cUTI:CAZ-AVI | Clinical Response at Follow-up 1 (FU1) in mMITT Analysis Set | Clinical failure | 5 Participant |
| cUTI:CAZ-AVI | Clinical Response at Follow-up 1 (FU1) in mMITT Analysis Set | Clinical cure | 127 Participant |
Secondary
Clinical Response at Follow-up 2 (FU2) in mMITT Analysis Set
Proportion of patients with clinical cure at the FU2 visit in the mMITT analysis set. Clinical cure: Complete resolution or significant improvement of signs and symptoms of the index infection such that no further antibacterial therapy (other than those allowed per protocol) is necessary; for cIAI patients no drainage or surgical intervention after 96 hours from randomization is necessary (ie. drainage or surgical intervention up to 96 hours from randomization is permissible).
Time frame: At FU2, data was only collected for the cUTI Arms: 28-34 calendar days from randomization
Population: Microbiological modified intent to treat
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| cUTI:Best Available Therapy | Clinical Response at Follow-up 2 (FU2) in mMITT Analysis Set | Clinical failure | 13 Participant |
| cUTI:Best Available Therapy | Clinical Response at Follow-up 2 (FU2) in mMITT Analysis Set | Clinical cure | 118 Participant |
| cUTI:Best Available Therapy | Clinical Response at Follow-up 2 (FU2) in mMITT Analysis Set | Indeterminate | 6 Participant |
| cUTI:CAZ-AVI | Clinical Response at Follow-up 2 (FU2) in mMITT Analysis Set | Clinical cure | 123 Participant |
| cUTI:CAZ-AVI | Clinical Response at Follow-up 2 (FU2) in mMITT Analysis Set | Clinical failure | 11 Participant |
| cUTI:CAZ-AVI | Clinical Response at Follow-up 2 (FU2) in mMITT Analysis Set | Indeterminate | 10 Participant |
Secondary
Clinical Response at FU1 in EME at FU1 Analysis Set.
Proportion of patients with clinical cure at the FU1 visit in EME at FU1 analysis set. Clinical cure: Complete resolution or significant improvement of signs and symptoms of the index infection such that no further antibacterial therapy (other than those allowed per protocol) is necessary; for cIAI patients no drainage or surgical intervention after 96 hours from randomization is necessary (ie. drainage or surgical intervention up to 96 hours from randomization is permissible).
Time frame: cIAI: 27-37 calendar days from randomization/cUTI: 20-27 calendar days from randomization
Population: Extended Microbiological Evaluable at FU1 analysis set.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| cIAI:Best Available Therapy | Clinical Response at FU1 in EME at FU1 Analysis Set. | Clinical failure | 0 Participant |
| cIAI:Best Available Therapy | Clinical Response at FU1 in EME at FU1 Analysis Set. | Clinical cure | 5 Participant |
| cIAI:CAZ-AVI + Metronidazole | Clinical Response at FU1 in EME at FU1 Analysis Set. | Clinical cure | 7 Participant |
| cIAI:CAZ-AVI + Metronidazole | Clinical Response at FU1 in EME at FU1 Analysis Set. | Clinical failure | 0 Participant |
| cUTI:Best Available Therapy | Clinical Response at FU1 in EME at FU1 Analysis Set. | Clinical cure | 110 Participant |
| cUTI:Best Available Therapy | Clinical Response at FU1 in EME at FU1 Analysis Set. | Clinical failure | 8 Participant |
| cUTI:CAZ-AVI | Clinical Response at FU1 in EME at FU1 Analysis Set. | Clinical failure | 4 Participant |
| cUTI:CAZ-AVI | Clinical Response at FU1 in EME at FU1 Analysis Set. | Clinical cure | 120 Participant |
Secondary
Clinical Response at FU2 in EME at FU2 Analysis Set
Proportion of patients with clinical cure at the FU2 visit in EME at FU2 analysis set. Clinical cure: Complete resolution or significant improvement of signs and symptoms of the index infection such that no further antibacterial therapy (other than those allowed per protocol) is necessary.
Time frame: At FU2, data was only collected for the cUTI Arms: 28-34 calendar days from randomization
Population: Extended Microbiological Evaluable at FU2 analysis set.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| cUTI:Best Available Therapy | Clinical Response at FU2 in EME at FU2 Analysis Set | Clinical cure | 102 Participant |
| cUTI:Best Available Therapy | Clinical Response at FU2 in EME at FU2 Analysis Set | Clinical failure | 12 Participant |
| cUTI:CAZ-AVI | Clinical Response at FU2 in EME at FU2 Analysis Set | Clinical cure | 106 Participant |
| cUTI:CAZ-AVI | Clinical Response at FU2 in EME at FU2 Analysis Set | Clinical failure | 10 Participant |
Secondary
Clinical Response at TOC in EME at TOC Analysis Set.
Proportion of patients with clinical cure at the TOC visit in the EME at TOC analysis set. Clinical cure: Complete resolution or significant improvement of signs and symptoms of the index infection such that no further antibacterial therapy (other than those allowed per protocol) is necessary; for cIAI patients no drainage or surgical intervention after 96 hours from randomization is necessary (ie. drainage or surgical intervention up to 96 hours from randomization is permissible).
Time frame: 6-12 days after last infusion of study therapy.Duration of study therapy was 5 to 21 days.
Population: Extended Microbiological Evaluable at TOC analysis set.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| cIAI:Best Available Therapy | Clinical Response at TOC in EME at TOC Analysis Set. | Clinical cure | 5 Participant |
| cIAI:Best Available Therapy | Clinical Response at TOC in EME at TOC Analysis Set. | Clinical failure | 0 Participant |
| cIAI:CAZ-AVI + Metronidazole | Clinical Response at TOC in EME at TOC Analysis Set. | Clinical failure | 0 Participant |
| cIAI:CAZ-AVI + Metronidazole | Clinical Response at TOC in EME at TOC Analysis Set. | Clinical cure | 8 Participant |
| cUTI:Best Available Therapy | Clinical Response at TOC in EME at TOC Analysis Set. | Clinical cure | 120 Participant |
| cUTI:Best Available Therapy | Clinical Response at TOC in EME at TOC Analysis Set. | Clinical failure | 2 Participant |
| cUTI:CAZ-AVI | Clinical Response at TOC in EME at TOC Analysis Set. | Clinical cure | 126 Participant |
| cUTI:CAZ-AVI | Clinical Response at TOC in EME at TOC Analysis Set. | Clinical failure | 2 Participant |
Secondary
Per-pathogen Microbiological Response of Gram-negative Pathogen at EOT in EME at EOT Analysis Set
Proportion of patients with a favorable per-pathogen microbiological response for pathogens (\>=10% of frequncy in the combined cIAI and cUTI patients): favourable microbiological response includes: Eradication Absence (or urine quantification less than 10\^4 CFU/ml for cUTI patients) of causative pathogen from an appropriately obtained specimen at the site of infection. If the patient was bacteremic at Screening, the bacteremia has also resolved. Presumed eradication where, repeat cultures were not performed/clinically indicated in a patient who had a clinical response of cure (specific to cIAI population).
Time frame: 28 hours after completion of last infusion of study therapy. Duration of study therapy was 5 to 21 days.
Population: Extended microbiologically evaluable at EOT
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| cIAI:Best Available Therapy | Per-pathogen Microbiological Response of Gram-negative Pathogen at EOT in EME at EOT Analysis Set | Kleb. pneumoniae - Unfavorable (n=2, 4, 60, 52) | 0 Participant |
| cIAI:Best Available Therapy | Per-pathogen Microbiological Response of Gram-negative Pathogen at EOT in EME at EOT Analysis Set | Escherichia coli - Unfavorable (n=2, 3, 51, 55) | 0 Participant |
| cIAI:Best Available Therapy | Per-pathogen Microbiological Response of Gram-negative Pathogen at EOT in EME at EOT Analysis Set | Escherichia coli - Favorable (n=2, 3, 51, 55) | 2 Participant |
| cIAI:Best Available Therapy | Per-pathogen Microbiological Response of Gram-negative Pathogen at EOT in EME at EOT Analysis Set | Pseudo. aeruginosa - Unfavorable (n=1, 1, 5, 14) | 0 Participant |
| cIAI:Best Available Therapy | Per-pathogen Microbiological Response of Gram-negative Pathogen at EOT in EME at EOT Analysis Set | Pseudo. aeruginosa - Favorable (n=1, 1, 5, 14) | 1 Participant |
| cIAI:Best Available Therapy | Per-pathogen Microbiological Response of Gram-negative Pathogen at EOT in EME at EOT Analysis Set | Kleb. pneumoniae - Favorable (n=2, 4, 60, 52) | 2 Participant |
| cIAI:CAZ-AVI + Metronidazole | Per-pathogen Microbiological Response of Gram-negative Pathogen at EOT in EME at EOT Analysis Set | Kleb. pneumoniae - Favorable (n=2, 4, 60, 52) | 4 Participant |
| cIAI:CAZ-AVI + Metronidazole | Per-pathogen Microbiological Response of Gram-negative Pathogen at EOT in EME at EOT Analysis Set | Kleb. pneumoniae - Unfavorable (n=2, 4, 60, 52) | 0 Participant |
| cIAI:CAZ-AVI + Metronidazole | Per-pathogen Microbiological Response of Gram-negative Pathogen at EOT in EME at EOT Analysis Set | Escherichia coli - Favorable (n=2, 3, 51, 55) | 3 Participant |
| cIAI:CAZ-AVI + Metronidazole | Per-pathogen Microbiological Response of Gram-negative Pathogen at EOT in EME at EOT Analysis Set | Pseudo. aeruginosa - Unfavorable (n=1, 1, 5, 14) | 0 Participant |
| cIAI:CAZ-AVI + Metronidazole | Per-pathogen Microbiological Response of Gram-negative Pathogen at EOT in EME at EOT Analysis Set | Pseudo. aeruginosa - Favorable (n=1, 1, 5, 14) | 1 Participant |
| cIAI:CAZ-AVI + Metronidazole | Per-pathogen Microbiological Response of Gram-negative Pathogen at EOT in EME at EOT Analysis Set | Escherichia coli - Unfavorable (n=2, 3, 51, 55) | 0 Participant |
| cUTI:Best Available Therapy | Per-pathogen Microbiological Response of Gram-negative Pathogen at EOT in EME at EOT Analysis Set | Kleb. pneumoniae - Favorable (n=2, 4, 60, 52) | 60 Participant |
| cUTI:Best Available Therapy | Per-pathogen Microbiological Response of Gram-negative Pathogen at EOT in EME at EOT Analysis Set | Escherichia coli - Favorable (n=2, 3, 51, 55) | 51 Participant |
| cUTI:Best Available Therapy | Per-pathogen Microbiological Response of Gram-negative Pathogen at EOT in EME at EOT Analysis Set | Escherichia coli - Unfavorable (n=2, 3, 51, 55) | 0 Participant |
| cUTI:Best Available Therapy | Per-pathogen Microbiological Response of Gram-negative Pathogen at EOT in EME at EOT Analysis Set | Kleb. pneumoniae - Unfavorable (n=2, 4, 60, 52) | 0 Participant |
| cUTI:Best Available Therapy | Per-pathogen Microbiological Response of Gram-negative Pathogen at EOT in EME at EOT Analysis Set | Pseudo. aeruginosa - Favorable (n=1, 1, 5, 14) | 5 Participant |
| cUTI:Best Available Therapy | Per-pathogen Microbiological Response of Gram-negative Pathogen at EOT in EME at EOT Analysis Set | Pseudo. aeruginosa - Unfavorable (n=1, 1, 5, 14) | 0 Participant |
| cUTI:CAZ-AVI | Per-pathogen Microbiological Response of Gram-negative Pathogen at EOT in EME at EOT Analysis Set | Escherichia coli - Favorable (n=2, 3, 51, 55) | 55 Participant |
| cUTI:CAZ-AVI | Per-pathogen Microbiological Response of Gram-negative Pathogen at EOT in EME at EOT Analysis Set | Pseudo. aeruginosa - Unfavorable (n=1, 1, 5, 14) | 0 Participant |
| cUTI:CAZ-AVI | Per-pathogen Microbiological Response of Gram-negative Pathogen at EOT in EME at EOT Analysis Set | Pseudo. aeruginosa - Favorable (n=1, 1, 5, 14) | 14 Participant |
| cUTI:CAZ-AVI | Per-pathogen Microbiological Response of Gram-negative Pathogen at EOT in EME at EOT Analysis Set | Kleb. pneumoniae - Favorable (n=2, 4, 60, 52) | 52 Participant |
| cUTI:CAZ-AVI | Per-pathogen Microbiological Response of Gram-negative Pathogen at EOT in EME at EOT Analysis Set | Kleb. pneumoniae - Unfavorable (n=2, 4, 60, 52) | 0 Participant |
| cUTI:CAZ-AVI | Per-pathogen Microbiological Response of Gram-negative Pathogen at EOT in EME at EOT Analysis Set | Escherichia coli - Unfavorable (n=2, 3, 51, 55) | 0 Participant |
Secondary
Per-pathogen Microbiological Response of Gram-negative Pathogen at EOT in mMITT Analysis Set
Proportion of patients with a favorable per-pathogen microbiological response for pathogens (\>=10% of frequency in the combined cIAI and cUTI patients): favourable microbiological response includes: Eradication Absence (or urine quantification less than 10\^4 CFU/ml for cUTI patients) of causative pathogen from an appropriately obtained specimen at the site of infection. If the patient was bacteremic at Screening, the bacteremia has also resolved. Presumed eradication where, repeat cultures were not performed/clinically indicated in a patient who had a clinical response of cure (specific to cIAI population).
Time frame: 28 hours after completion of last infusion of study therapy. Duration of study therapy was 5 to 21 days.
Population: Microbiological modified intent to treat
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| cIAI:Best Available Therapy | Per-pathogen Microbiological Response of Gram-negative Pathogen at EOT in mMITT Analysis Set | Pseudo. aeruginosa - Favorable (n=1, 1, 5, 14) | 1 Participant |
| cIAI:Best Available Therapy | Per-pathogen Microbiological Response of Gram-negative Pathogen at EOT in mMITT Analysis Set | Kleb. pneumoniae - Indeterminate (n=3, 5, 65, 55) | 1 Participant |
| cIAI:Best Available Therapy | Per-pathogen Microbiological Response of Gram-negative Pathogen at EOT in mMITT Analysis Set | Pseudo. aeruginosa - Indeterminate (n=1, 1, 5, 14) | 0 Participant |
| cIAI:Best Available Therapy | Per-pathogen Microbiological Response of Gram-negative Pathogen at EOT in mMITT Analysis Set | Kleb. pneumoniae - Favorable (n=3, 5, 65, 55) | 2 Participant |
| cIAI:Best Available Therapy | Per-pathogen Microbiological Response of Gram-negative Pathogen at EOT in mMITT Analysis Set | Escherichia coli - Indeterminate (n=6, 4, 57, 59) | 4 Participant |
| cIAI:Best Available Therapy | Per-pathogen Microbiological Response of Gram-negative Pathogen at EOT in mMITT Analysis Set | Escherichia coli - Unfavorable (n=6, 4, 57, 59) | 0 Participant |
| cIAI:Best Available Therapy | Per-pathogen Microbiological Response of Gram-negative Pathogen at EOT in mMITT Analysis Set | Pseudo. aeruginosa - Unfavorable (n=1, 1, 5, 14) | 0 Participant |
| cIAI:Best Available Therapy | Per-pathogen Microbiological Response of Gram-negative Pathogen at EOT in mMITT Analysis Set | Kleb. pneumoniae - Unfavorable (n=3, 5, 65, 55) | 0 Participant |
| cIAI:Best Available Therapy | Per-pathogen Microbiological Response of Gram-negative Pathogen at EOT in mMITT Analysis Set | Escherichia coli - Favorable (n=6, 4, 57, 59) | 2 Participant |
| cIAI:CAZ-AVI + Metronidazole | Per-pathogen Microbiological Response of Gram-negative Pathogen at EOT in mMITT Analysis Set | Kleb. pneumoniae - Unfavorable (n=3, 5, 65, 55) | 0 Participant |
| cIAI:CAZ-AVI + Metronidazole | Per-pathogen Microbiological Response of Gram-negative Pathogen at EOT in mMITT Analysis Set | Pseudo. aeruginosa - Favorable (n=1, 1, 5, 14) | 1 Participant |
| cIAI:CAZ-AVI + Metronidazole | Per-pathogen Microbiological Response of Gram-negative Pathogen at EOT in mMITT Analysis Set | Kleb. pneumoniae - Indeterminate (n=3, 5, 65, 55) | 1 Participant |
| cIAI:CAZ-AVI + Metronidazole | Per-pathogen Microbiological Response of Gram-negative Pathogen at EOT in mMITT Analysis Set | Escherichia coli - Unfavorable (n=6, 4, 57, 59) | 0 Participant |
| cIAI:CAZ-AVI + Metronidazole | Per-pathogen Microbiological Response of Gram-negative Pathogen at EOT in mMITT Analysis Set | Escherichia coli - Favorable (n=6, 4, 57, 59) | 3 Participant |
| cIAI:CAZ-AVI + Metronidazole | Per-pathogen Microbiological Response of Gram-negative Pathogen at EOT in mMITT Analysis Set | Escherichia coli - Indeterminate (n=6, 4, 57, 59) | 1 Participant |
| cIAI:CAZ-AVI + Metronidazole | Per-pathogen Microbiological Response of Gram-negative Pathogen at EOT in mMITT Analysis Set | Pseudo. aeruginosa - Indeterminate (n=1, 1, 5, 14) | 0 Participant |
| cIAI:CAZ-AVI + Metronidazole | Per-pathogen Microbiological Response of Gram-negative Pathogen at EOT in mMITT Analysis Set | Pseudo. aeruginosa - Unfavorable (n=1, 1, 5, 14) | 0 Participant |
| cIAI:CAZ-AVI + Metronidazole | Per-pathogen Microbiological Response of Gram-negative Pathogen at EOT in mMITT Analysis Set | Kleb. pneumoniae - Favorable (n=3, 5, 65, 55) | 4 Participant |
| cUTI:Best Available Therapy | Per-pathogen Microbiological Response of Gram-negative Pathogen at EOT in mMITT Analysis Set | Kleb. pneumoniae - Unfavorable (n=3, 5, 65, 55) | 1 Participant |
| cUTI:Best Available Therapy | Per-pathogen Microbiological Response of Gram-negative Pathogen at EOT in mMITT Analysis Set | Escherichia coli - Favorable (n=6, 4, 57, 59) | 53 Participant |
| cUTI:Best Available Therapy | Per-pathogen Microbiological Response of Gram-negative Pathogen at EOT in mMITT Analysis Set | Escherichia coli - Unfavorable (n=6, 4, 57, 59) | 0 Participant |
| cUTI:Best Available Therapy | Per-pathogen Microbiological Response of Gram-negative Pathogen at EOT in mMITT Analysis Set | Escherichia coli - Indeterminate (n=6, 4, 57, 59) | 4 Participant |
| cUTI:Best Available Therapy | Per-pathogen Microbiological Response of Gram-negative Pathogen at EOT in mMITT Analysis Set | Kleb. pneumoniae - Favorable (n=3, 5, 65, 55) | 61 Participant |
| cUTI:Best Available Therapy | Per-pathogen Microbiological Response of Gram-negative Pathogen at EOT in mMITT Analysis Set | Kleb. pneumoniae - Indeterminate (n=3, 5, 65, 55) | 3 Participant |
| cUTI:Best Available Therapy | Per-pathogen Microbiological Response of Gram-negative Pathogen at EOT in mMITT Analysis Set | Pseudo. aeruginosa - Favorable (n=1, 1, 5, 14) | 5 Participant |
| cUTI:Best Available Therapy | Per-pathogen Microbiological Response of Gram-negative Pathogen at EOT in mMITT Analysis Set | Pseudo. aeruginosa - Unfavorable (n=1, 1, 5, 14) | 0 Participant |
| cUTI:Best Available Therapy | Per-pathogen Microbiological Response of Gram-negative Pathogen at EOT in mMITT Analysis Set | Pseudo. aeruginosa - Indeterminate (n=1, 1, 5, 14) | 0 Participant |
| cUTI:CAZ-AVI | Per-pathogen Microbiological Response of Gram-negative Pathogen at EOT in mMITT Analysis Set | Pseudo. aeruginosa - Favorable (n=1, 1, 5, 14) | 14 Participant |
| cUTI:CAZ-AVI | Per-pathogen Microbiological Response of Gram-negative Pathogen at EOT in mMITT Analysis Set | Kleb. pneumoniae - Favorable (n=3, 5, 65, 55) | 52 Participant |
| cUTI:CAZ-AVI | Per-pathogen Microbiological Response of Gram-negative Pathogen at EOT in mMITT Analysis Set | Escherichia coli - Indeterminate (n=6, 4, 57, 59) | 2 Participant |
| cUTI:CAZ-AVI | Per-pathogen Microbiological Response of Gram-negative Pathogen at EOT in mMITT Analysis Set | Pseudo. aeruginosa - Indeterminate (n=1, 1, 5, 14) | 0 Participant |
| cUTI:CAZ-AVI | Per-pathogen Microbiological Response of Gram-negative Pathogen at EOT in mMITT Analysis Set | Pseudo. aeruginosa - Unfavorable (n=1, 1, 5, 14) | 0 Participant |
| cUTI:CAZ-AVI | Per-pathogen Microbiological Response of Gram-negative Pathogen at EOT in mMITT Analysis Set | Escherichia coli - Unfavorable (n=6, 4, 57, 59) | 0 Participant |
| cUTI:CAZ-AVI | Per-pathogen Microbiological Response of Gram-negative Pathogen at EOT in mMITT Analysis Set | Kleb. pneumoniae - Indeterminate (n=3, 5, 65, 55) | 3 Participant |
| cUTI:CAZ-AVI | Per-pathogen Microbiological Response of Gram-negative Pathogen at EOT in mMITT Analysis Set | Kleb. pneumoniae - Unfavorable (n=3, 5, 65, 55) | 0 Participant |
| cUTI:CAZ-AVI | Per-pathogen Microbiological Response of Gram-negative Pathogen at EOT in mMITT Analysis Set | Escherichia coli - Favorable (n=6, 4, 57, 59) | 57 Participant |
Secondary
Per-pathogen Microbiological Response of Gram-negative Pathogen at FU1 in EME at FU1 Analysis Set
Proportion of patients with a favorable per-pathogen microbiological response for pathogens (\>=10% of frequncy in the combined cIAI and cUTI patients): favourable microbiological response includes: Eradication Absence (or urine quantification less than 10\^4 CFU/ml for cUTI patients) of causative pathogen from an appropriately obtained specimen at the site of infection. If the patient was bacteremic at Screening, the bacteremia has also resolved. Presumed eradication where, repeat cultures were not performed/clinically indicated in a patient who had a clinical response of cure (specific to cIAI population).
Time frame: cIAI: 27-37 calendar days from randomization/cUTI: 20-27 calendar days from randomization
Population: Extended microbiologically evaluable at FU1
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| cIAI:Best Available Therapy | Per-pathogen Microbiological Response of Gram-negative Pathogen at FU1 in EME at FU1 Analysis Set | Pseudo. aeruginosa - Favorable (n=1, 1, 5, 10) | 1 Participant |
| cIAI:Best Available Therapy | Per-pathogen Microbiological Response of Gram-negative Pathogen at FU1 in EME at FU1 Analysis Set | Escherichia coli - Unfavorable (n=2, 3, 46, 54) | 0 Participant |
| cIAI:Best Available Therapy | Per-pathogen Microbiological Response of Gram-negative Pathogen at FU1 in EME at FU1 Analysis Set | Escherichia coli - Favorable (n=2, 3, 46, 54) | 2 Participant |
| cIAI:Best Available Therapy | Per-pathogen Microbiological Response of Gram-negative Pathogen at FU1 in EME at FU1 Analysis Set | Kleb. pneumoniae - Favorable (n=2, 2, 59, 50) | 2 Participant |
| cIAI:Best Available Therapy | Per-pathogen Microbiological Response of Gram-negative Pathogen at FU1 in EME at FU1 Analysis Set | Kleb. pneumoniae - Unfavorable (n=2, 2, 59, 50) | 0 Participant |
| cIAI:Best Available Therapy | Per-pathogen Microbiological Response of Gram-negative Pathogen at FU1 in EME at FU1 Analysis Set | Pseudo. aeruginosa - Unfavorable (n=1, 1, 5, 10) | 0 Participant |
| cIAI:CAZ-AVI + Metronidazole | Per-pathogen Microbiological Response of Gram-negative Pathogen at FU1 in EME at FU1 Analysis Set | Pseudo. aeruginosa - Favorable (n=1, 1, 5, 10) | 1 Participant |
| cIAI:CAZ-AVI + Metronidazole | Per-pathogen Microbiological Response of Gram-negative Pathogen at FU1 in EME at FU1 Analysis Set | Pseudo. aeruginosa - Unfavorable (n=1, 1, 5, 10) | 0 Participant |
| cIAI:CAZ-AVI + Metronidazole | Per-pathogen Microbiological Response of Gram-negative Pathogen at FU1 in EME at FU1 Analysis Set | Escherichia coli - Unfavorable (n=2, 3, 46, 54) | 0 Participant |
| cIAI:CAZ-AVI + Metronidazole | Per-pathogen Microbiological Response of Gram-negative Pathogen at FU1 in EME at FU1 Analysis Set | Kleb. pneumoniae - Favorable (n=2, 2, 59, 50) | 2 Participant |
| cIAI:CAZ-AVI + Metronidazole | Per-pathogen Microbiological Response of Gram-negative Pathogen at FU1 in EME at FU1 Analysis Set | Kleb. pneumoniae - Unfavorable (n=2, 2, 59, 50) | 0 Participant |
| cIAI:CAZ-AVI + Metronidazole | Per-pathogen Microbiological Response of Gram-negative Pathogen at FU1 in EME at FU1 Analysis Set | Escherichia coli - Favorable (n=2, 3, 46, 54) | 3 Participant |
| cUTI:Best Available Therapy | Per-pathogen Microbiological Response of Gram-negative Pathogen at FU1 in EME at FU1 Analysis Set | Escherichia coli - Unfavorable (n=2, 3, 46, 54) | 16 Participant |
| cUTI:Best Available Therapy | Per-pathogen Microbiological Response of Gram-negative Pathogen at FU1 in EME at FU1 Analysis Set | Pseudo. aeruginosa - Unfavorable (n=1, 1, 5, 10) | 2 Participant |
| cUTI:Best Available Therapy | Per-pathogen Microbiological Response of Gram-negative Pathogen at FU1 in EME at FU1 Analysis Set | Escherichia coli - Favorable (n=2, 3, 46, 54) | 30 Participant |
| cUTI:Best Available Therapy | Per-pathogen Microbiological Response of Gram-negative Pathogen at FU1 in EME at FU1 Analysis Set | Kleb. pneumoniae - Unfavorable (n=2, 2, 59, 50) | 21 Participant |
| cUTI:Best Available Therapy | Per-pathogen Microbiological Response of Gram-negative Pathogen at FU1 in EME at FU1 Analysis Set | Pseudo. aeruginosa - Favorable (n=1, 1, 5, 10) | 3 Participant |
| cUTI:Best Available Therapy | Per-pathogen Microbiological Response of Gram-negative Pathogen at FU1 in EME at FU1 Analysis Set | Kleb. pneumoniae - Favorable (n=2, 2, 59, 50) | 38 Participant |
| cUTI:CAZ-AVI | Per-pathogen Microbiological Response of Gram-negative Pathogen at FU1 in EME at FU1 Analysis Set | Pseudo. aeruginosa - Unfavorable (n=1, 1, 5, 10) | 2 Participant |
| cUTI:CAZ-AVI | Per-pathogen Microbiological Response of Gram-negative Pathogen at FU1 in EME at FU1 Analysis Set | Escherichia coli - Favorable (n=2, 3, 46, 54) | 43 Participant |
| cUTI:CAZ-AVI | Per-pathogen Microbiological Response of Gram-negative Pathogen at FU1 in EME at FU1 Analysis Set | Escherichia coli - Unfavorable (n=2, 3, 46, 54) | 11 Participant |
| cUTI:CAZ-AVI | Per-pathogen Microbiological Response of Gram-negative Pathogen at FU1 in EME at FU1 Analysis Set | Kleb. pneumoniae - Favorable (n=2, 2, 59, 50) | 40 Participant |
| cUTI:CAZ-AVI | Per-pathogen Microbiological Response of Gram-negative Pathogen at FU1 in EME at FU1 Analysis Set | Kleb. pneumoniae - Unfavorable (n=2, 2, 59, 50) | 10 Participant |
| cUTI:CAZ-AVI | Per-pathogen Microbiological Response of Gram-negative Pathogen at FU1 in EME at FU1 Analysis Set | Pseudo. aeruginosa - Favorable (n=1, 1, 5, 10) | 8 Participant |
Secondary
Per-pathogen Microbiological Response of Gram-negative Pathogen at FU1 in mMITT Analysis Set
Proportion of patients with a favorable per-pathogen microbiological response for pathogens (\>=10% of frequency in the combined cIAI and cUTI patients): favourable microbiological response includes: Eradication Absence (or urine quantification less than 10\^4 CFU/ml for cUTI patients) of causative pathogen from an appropriately obtained specimen at the site of infection. If the patient was bacteremic at Screening, the bacteremia has also resolved. Presumed eradication where, repeat cultures were not performed/clinically indicated in a patient who had a clinical response of cure (specific to cIAI population).
Time frame: cIAI: 27-37 calendar days from randomization/cUTI: 20-27 calendar days from randomization
Population: Microbiological modified intent to treat
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| cIAI:Best Available Therapy | Per-pathogen Microbiological Response of Gram-negative Pathogen at FU1 in mMITT Analysis Set | Escherichia coli - Indeterminate (n=6, 4, 57, 59) | 4 Participant |
| cIAI:Best Available Therapy | Per-pathogen Microbiological Response of Gram-negative Pathogen at FU1 in mMITT Analysis Set | Pseudo. aeruginosa - Unfavorable (n=1, 1, 5, 14) | 0 Participant |
| cIAI:Best Available Therapy | Per-pathogen Microbiological Response of Gram-negative Pathogen at FU1 in mMITT Analysis Set | Kleb. pneumoniae - Favorable (n=3, 5, 65, 55) | 2 Participant |
| cIAI:Best Available Therapy | Per-pathogen Microbiological Response of Gram-negative Pathogen at FU1 in mMITT Analysis Set | Pseudo. aeruginosa - Favorable (n=1, 1, 5, 14) | 1 Participant |
| cIAI:Best Available Therapy | Per-pathogen Microbiological Response of Gram-negative Pathogen at FU1 in mMITT Analysis Set | Kleb. pneumoniae - Indeterminate (n=3, 5, 65, 55) | 1 Participant |
| cIAI:Best Available Therapy | Per-pathogen Microbiological Response of Gram-negative Pathogen at FU1 in mMITT Analysis Set | Kleb. pneumoniae - Unfavorable (n=3, 5, 65, 55) | 0 Participant |
| cIAI:Best Available Therapy | Per-pathogen Microbiological Response of Gram-negative Pathogen at FU1 in mMITT Analysis Set | Escherichia coli - Unfavorable (n=6, 4, 57, 59) | 0 Participant |
| cIAI:Best Available Therapy | Per-pathogen Microbiological Response of Gram-negative Pathogen at FU1 in mMITT Analysis Set | Escherichia coli - Favorable (n=6, 4, 57, 59) | 2 Participant |
| cIAI:Best Available Therapy | Per-pathogen Microbiological Response of Gram-negative Pathogen at FU1 in mMITT Analysis Set | Pseudo. aeruginosa - Indeterminate (n=1, 1, 5, 14) | 0 Participant |
| cIAI:CAZ-AVI + Metronidazole | Per-pathogen Microbiological Response of Gram-negative Pathogen at FU1 in mMITT Analysis Set | Pseudo. aeruginosa - Favorable (n=1, 1, 5, 14) | 1 Participant |
| cIAI:CAZ-AVI + Metronidazole | Per-pathogen Microbiological Response of Gram-negative Pathogen at FU1 in mMITT Analysis Set | Escherichia coli - Indeterminate (n=6, 4, 57, 59) | 1 Participant |
| cIAI:CAZ-AVI + Metronidazole | Per-pathogen Microbiological Response of Gram-negative Pathogen at FU1 in mMITT Analysis Set | Pseudo. aeruginosa - Indeterminate (n=1, 1, 5, 14) | 0 Participant |
| cIAI:CAZ-AVI + Metronidazole | Per-pathogen Microbiological Response of Gram-negative Pathogen at FU1 in mMITT Analysis Set | Kleb. pneumoniae - Favorable (n=3, 5, 65, 55) | 3 Participant |
| cIAI:CAZ-AVI + Metronidazole | Per-pathogen Microbiological Response of Gram-negative Pathogen at FU1 in mMITT Analysis Set | Kleb. pneumoniae - Indeterminate (n=3, 5, 65, 55) | 2 Participant |
| cIAI:CAZ-AVI + Metronidazole | Per-pathogen Microbiological Response of Gram-negative Pathogen at FU1 in mMITT Analysis Set | Escherichia coli - Favorable (n=6, 4, 57, 59) | 3 Participant |
| cIAI:CAZ-AVI + Metronidazole | Per-pathogen Microbiological Response of Gram-negative Pathogen at FU1 in mMITT Analysis Set | Pseudo. aeruginosa - Unfavorable (n=1, 1, 5, 14) | 0 Participant |
| cIAI:CAZ-AVI + Metronidazole | Per-pathogen Microbiological Response of Gram-negative Pathogen at FU1 in mMITT Analysis Set | Kleb. pneumoniae - Unfavorable (n=3, 5, 65, 55) | 0 Participant |
| cIAI:CAZ-AVI + Metronidazole | Per-pathogen Microbiological Response of Gram-negative Pathogen at FU1 in mMITT Analysis Set | Escherichia coli - Unfavorable (n=6, 4, 57, 59) | 0 Participant |
| cUTI:Best Available Therapy | Per-pathogen Microbiological Response of Gram-negative Pathogen at FU1 in mMITT Analysis Set | Pseudo. aeruginosa - Unfavorable (n=1, 1, 5, 14) | 2 Participant |
| cUTI:Best Available Therapy | Per-pathogen Microbiological Response of Gram-negative Pathogen at FU1 in mMITT Analysis Set | Escherichia coli - Unfavorable (n=6, 4, 57, 59) | 18 Participant |
| cUTI:Best Available Therapy | Per-pathogen Microbiological Response of Gram-negative Pathogen at FU1 in mMITT Analysis Set | Kleb. pneumoniae - Unfavorable (n=3, 5, 65, 55) | 23 Participant |
| cUTI:Best Available Therapy | Per-pathogen Microbiological Response of Gram-negative Pathogen at FU1 in mMITT Analysis Set | Pseudo. aeruginosa - Indeterminate (n=1, 1, 5, 14) | 0 Participant |
| cUTI:Best Available Therapy | Per-pathogen Microbiological Response of Gram-negative Pathogen at FU1 in mMITT Analysis Set | Kleb. pneumoniae - Favorable (n=3, 5, 65, 55) | 39 Participant |
| cUTI:Best Available Therapy | Per-pathogen Microbiological Response of Gram-negative Pathogen at FU1 in mMITT Analysis Set | Escherichia coli - Favorable (n=6, 4, 57, 59) | 33 Participant |
| cUTI:Best Available Therapy | Per-pathogen Microbiological Response of Gram-negative Pathogen at FU1 in mMITT Analysis Set | Pseudo. aeruginosa - Favorable (n=1, 1, 5, 14) | 3 Participant |
| cUTI:Best Available Therapy | Per-pathogen Microbiological Response of Gram-negative Pathogen at FU1 in mMITT Analysis Set | Kleb. pneumoniae - Indeterminate (n=3, 5, 65, 55) | 3 Participant |
| cUTI:Best Available Therapy | Per-pathogen Microbiological Response of Gram-negative Pathogen at FU1 in mMITT Analysis Set | Escherichia coli - Indeterminate (n=6, 4, 57, 59) | 6 Participant |
| cUTI:CAZ-AVI | Per-pathogen Microbiological Response of Gram-negative Pathogen at FU1 in mMITT Analysis Set | Pseudo. aeruginosa - Indeterminate (n=1, 1, 5, 14) | 4 Participant |
| cUTI:CAZ-AVI | Per-pathogen Microbiological Response of Gram-negative Pathogen at FU1 in mMITT Analysis Set | Escherichia coli - Favorable (n=6, 4, 57, 59) | 45 Participant |
| cUTI:CAZ-AVI | Per-pathogen Microbiological Response of Gram-negative Pathogen at FU1 in mMITT Analysis Set | Kleb. pneumoniae - Unfavorable (n=3, 5, 65, 55) | 10 Participant |
| cUTI:CAZ-AVI | Per-pathogen Microbiological Response of Gram-negative Pathogen at FU1 in mMITT Analysis Set | Kleb. pneumoniae - Indeterminate (n=3, 5, 65, 55) | 3 Participant |
| cUTI:CAZ-AVI | Per-pathogen Microbiological Response of Gram-negative Pathogen at FU1 in mMITT Analysis Set | Pseudo. aeruginosa - Favorable (n=1, 1, 5, 14) | 8 Participant |
| cUTI:CAZ-AVI | Per-pathogen Microbiological Response of Gram-negative Pathogen at FU1 in mMITT Analysis Set | Pseudo. aeruginosa - Unfavorable (n=1, 1, 5, 14) | 2 Participant |
| cUTI:CAZ-AVI | Per-pathogen Microbiological Response of Gram-negative Pathogen at FU1 in mMITT Analysis Set | Escherichia coli - Unfavorable (n=6, 4, 57, 59) | 12 Participant |
| cUTI:CAZ-AVI | Per-pathogen Microbiological Response of Gram-negative Pathogen at FU1 in mMITT Analysis Set | Escherichia coli - Indeterminate (n=6, 4, 57, 59) | 2 Participant |
| cUTI:CAZ-AVI | Per-pathogen Microbiological Response of Gram-negative Pathogen at FU1 in mMITT Analysis Set | Kleb. pneumoniae - Favorable (n=3, 5, 65, 55) | 42 Participant |
Secondary
Per-pathogen Microbiological Response of Gram-negative Pathogen at FU2 in EME at FU2 Analysis Set
Proportion of patients with a favorable per-pathogen microbiological response for pathogens (\>=10% of frequncy in the combined cIAI and cUTI patients): favourable microbiological response includes: Eradication Absence (or urine quantification less than 10\^4 CFU/ml for cUTI patients) of causative pathogen from an appropriately obtained specimen at the site of infection. If the patient was bacteremic at Screening, the bacteremia has also resolved. Presumed eradication where, repeat cultures were not performed/clinically indicated in a patient who had a clinical response of cure (specific to cIAI population).
Time frame: At FU2, data was only collected for the cUTI Arms: 28-34 calendar days from randomization
Population: Extended microbiologically evaluable at FU2
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| cUTI:Best Available Therapy | Per-pathogen Microbiological Response of Gram-negative Pathogen at FU2 in EME at FU2 Analysis Set | Escherichia coli - Unfavorable (n=44, 50) | 16 Participant |
| cUTI:Best Available Therapy | Per-pathogen Microbiological Response of Gram-negative Pathogen at FU2 in EME at FU2 Analysis Set | Kleb. pneumoniae - Unfavorable (n=56, 46) | 23 Participant |
| cUTI:Best Available Therapy | Per-pathogen Microbiological Response of Gram-negative Pathogen at FU2 in EME at FU2 Analysis Set | Escherichia coli - Favorable (n=44, 50) | 28 Participant |
| cUTI:Best Available Therapy | Per-pathogen Microbiological Response of Gram-negative Pathogen at FU2 in EME at FU2 Analysis Set | Pseudo. aeruginosa - Favorable (n=4, 11) | 2 Participant |
| cUTI:Best Available Therapy | Per-pathogen Microbiological Response of Gram-negative Pathogen at FU2 in EME at FU2 Analysis Set | Pseudo. aeruginosa - Unfavorable (n=4, 11) | 2 Participant |
| cUTI:Best Available Therapy | Per-pathogen Microbiological Response of Gram-negative Pathogen at FU2 in EME at FU2 Analysis Set | Kleb. pneumoniae - Favorable (n= 56, 46) | 33 Participant |
| cUTI:CAZ-AVI | Per-pathogen Microbiological Response of Gram-negative Pathogen at FU2 in EME at FU2 Analysis Set | Pseudo. aeruginosa - Unfavorable (n=4, 11) | 2 Participant |
| cUTI:CAZ-AVI | Per-pathogen Microbiological Response of Gram-negative Pathogen at FU2 in EME at FU2 Analysis Set | Escherichia coli - Favorable (n=44, 50) | 39 Participant |
| cUTI:CAZ-AVI | Per-pathogen Microbiological Response of Gram-negative Pathogen at FU2 in EME at FU2 Analysis Set | Escherichia coli - Unfavorable (n=44, 50) | 11 Participant |
| cUTI:CAZ-AVI | Per-pathogen Microbiological Response of Gram-negative Pathogen at FU2 in EME at FU2 Analysis Set | Kleb. pneumoniae - Favorable (n= 56, 46) | 32 Participant |
| cUTI:CAZ-AVI | Per-pathogen Microbiological Response of Gram-negative Pathogen at FU2 in EME at FU2 Analysis Set | Kleb. pneumoniae - Unfavorable (n=56, 46) | 14 Participant |
| cUTI:CAZ-AVI | Per-pathogen Microbiological Response of Gram-negative Pathogen at FU2 in EME at FU2 Analysis Set | Pseudo. aeruginosa - Favorable (n=4, 11) | 9 Participant |
Secondary
Per-pathogen Microbiological Response of Gram-negative Pathogen at FU2 in mMITT Analysis Set
Proportion of patients with a favorable per-pathogen microbiological response for pathogens (\>=10% of frequncy in the combined cIAI and cUTI patients): favourable microbiological response includes: Eradication Absence (or urine quantification less than 10\^4 CFU/ml for cUTI patients) of causative pathogen from an appropriately obtained specimen at the site of infection. If the patient was bacteremic at Screening, the bacteremia has also resolved. Presumed eradication where, repeat cultures were not performed/clinically indicated in a patient who had a clinical response of cure (specific to cIAI population).
Time frame: At FU2, data was only collected for the cUTI Arms: 28-34 calendar days from randomization
Population: Microbiological modified intent to treat
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| cUTI:Best Available Therapy | Per-pathogen Microbiological Response of Gram-negative Pathogen at FU2 in mMITT Analysis Set | Escherichia coli - Unfavorable (n=0, 0, 57, 59) | 19 Participant |
| cUTI:Best Available Therapy | Per-pathogen Microbiological Response of Gram-negative Pathogen at FU2 in mMITT Analysis Set | Kleb. pneumoniae - Indeterminate (n=0, 0, 65, 55) | 4 Participant |
| cUTI:Best Available Therapy | Per-pathogen Microbiological Response of Gram-negative Pathogen at FU2 in mMITT Analysis Set | Kleb. pneumoniae - Favorable (n=0, 0, 65, 55) | 35 Participant |
| cUTI:Best Available Therapy | Per-pathogen Microbiological Response of Gram-negative Pathogen at FU2 in mMITT Analysis Set | Pseudo. aeruginosa - Favorable (n=0, 0, 5, 14) | 2 Participant |
| cUTI:Best Available Therapy | Per-pathogen Microbiological Response of Gram-negative Pathogen at FU2 in mMITT Analysis Set | Escherichia coli - Indeterminate (n=0, 0, 57, 59) | 6 Participant |
| cUTI:Best Available Therapy | Per-pathogen Microbiological Response of Gram-negative Pathogen at FU2 in mMITT Analysis Set | Pseudo. aeruginosa - Unfavorable (n=0, 0, 5, 14) | 3 Participant |
| cUTI:Best Available Therapy | Per-pathogen Microbiological Response of Gram-negative Pathogen at FU2 in mMITT Analysis Set | Kleb. pneumoniae - Unfavorable (n=0, 0, 65, 55) | 26 Participant |
| cUTI:Best Available Therapy | Per-pathogen Microbiological Response of Gram-negative Pathogen at FU2 in mMITT Analysis Set | Pseudo. aeruginosa - Indeterminate (n=0, 0, 5, 14) | 0 Participant |
| cUTI:Best Available Therapy | Per-pathogen Microbiological Response of Gram-negative Pathogen at FU2 in mMITT Analysis Set | Escherichia coli - Favorable (n=0, 0, 57, 59) | 32 Participant |
| cUTI:CAZ-AVI | Per-pathogen Microbiological Response of Gram-negative Pathogen at FU2 in mMITT Analysis Set | Pseudo. aeruginosa - Indeterminate (n=0, 0, 5, 14) | 2 Participant |
| cUTI:CAZ-AVI | Per-pathogen Microbiological Response of Gram-negative Pathogen at FU2 in mMITT Analysis Set | Escherichia coli - Favorable (n=0, 0, 57, 59) | 43 Participant |
| cUTI:CAZ-AVI | Per-pathogen Microbiological Response of Gram-negative Pathogen at FU2 in mMITT Analysis Set | Escherichia coli - Unfavorable (n=0, 0, 57, 59) | 14 Participant |
| cUTI:CAZ-AVI | Per-pathogen Microbiological Response of Gram-negative Pathogen at FU2 in mMITT Analysis Set | Escherichia coli - Indeterminate (n=0, 0, 57, 59) | 2 Participant |
| cUTI:CAZ-AVI | Per-pathogen Microbiological Response of Gram-negative Pathogen at FU2 in mMITT Analysis Set | Kleb. pneumoniae - Favorable (n=0, 0, 65, 55) | 39 Participant |
| cUTI:CAZ-AVI | Per-pathogen Microbiological Response of Gram-negative Pathogen at FU2 in mMITT Analysis Set | Kleb. pneumoniae - Unfavorable (n=0, 0, 65, 55) | 14 Participant |
| cUTI:CAZ-AVI | Per-pathogen Microbiological Response of Gram-negative Pathogen at FU2 in mMITT Analysis Set | Kleb. pneumoniae - Indeterminate (n=0, 0, 65, 55) | 2 Participant |
| cUTI:CAZ-AVI | Per-pathogen Microbiological Response of Gram-negative Pathogen at FU2 in mMITT Analysis Set | Pseudo. aeruginosa - Favorable (n=0, 0, 5, 14) | 10 Participant |
| cUTI:CAZ-AVI | Per-pathogen Microbiological Response of Gram-negative Pathogen at FU2 in mMITT Analysis Set | Pseudo. aeruginosa - Unfavorable (n=0, 0, 5, 14) | 2 Participant |
Secondary
Per-pathogen Microbiological Response of Gram-negative Pathogen at TOC by CAZ-AVI MIC in EME at TOC Analysis Set
Proportion of patients with a favorable per-pathogen microbiological response for pathogens (\>=10% of frequncy in the combined cIAI and cUTI patients): favourable microbiological response includes: Eradication Absence (or urine quantification less than 10\^4 CFU/ml for cUTI patients) of causative pathogen from an appropriately obtained specimen at the site of infection. If the patient was bacteremic at Screening, the bacteremia has also resolved. Presumed eradication where, repeat cultures were not performed/clinically indicated in a patient who had a clinical response of cure (specific to cIAI population). For E.coli, MIC available values are: \<=0.008, 0.03, 0.06, 0.12, 0.25, 0.5, 1, 2, 8. For K. pneumoniae, MIC available values are: 0.06, 0.12, 0.25, 0.5, 1, 2, 4, \>32. For P. aeruginosa, MIC available values are: 2, 4, 8, 16, 32, \>32.
Time frame: 6-12 days after last infusion of study therapy. Duration of study therapy was 5 to 21 days.
Population: Extended microbiologically evaluable at TOC
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| cIAI:Best Available Therapy | Per-pathogen Microbiological Response of Gram-negative Pathogen at TOC by CAZ-AVI MIC in EME at TOC Analysis Set | E. coli (MIC: 0.12) - Favorable (n=2, 1, 18, 18) | 2 Participant |
| cIAI:Best Available Therapy | Per-pathogen Microbiological Response of Gram-negative Pathogen at TOC by CAZ-AVI MIC in EME at TOC Analysis Set | K. pneumoniae (MIC: 0.25) - Favorable (n=0,2,11,6) | 0 Participant |
| cIAI:Best Available Therapy | Per-pathogen Microbiological Response of Gram-negative Pathogen at TOC by CAZ-AVI MIC in EME at TOC Analysis Set | P. aeruginosa (MIC: 16) - Favorable (n=0, 1, 0, 1) | 0 Participant |
| cIAI:Best Available Therapy | Per-pathogen Microbiological Response of Gram-negative Pathogen at TOC by CAZ-AVI MIC in EME at TOC Analysis Set | E. coli (MIC: 0.03) - Favorable (n=0, 0, 0, 2) | 0 Participant |
| cIAI:Best Available Therapy | Per-pathogen Microbiological Response of Gram-negative Pathogen at TOC by CAZ-AVI MIC in EME at TOC Analysis Set | E. coli (MIC: 0.25) - Favorable (n=0, 0, 13, 15) | 0 Participant |
| cIAI:Best Available Therapy | Per-pathogen Microbiological Response of Gram-negative Pathogen at TOC by CAZ-AVI MIC in EME at TOC Analysis Set | E. coli (MIC: <=0.008) - Favorable (n=0, 0, 1, 1) | 0 Participant |
| cIAI:Best Available Therapy | Per-pathogen Microbiological Response of Gram-negative Pathogen at TOC by CAZ-AVI MIC in EME at TOC Analysis Set | P. aeruginosa (MIC: 4) - Favorable (n=0, 0, 3, 2) | 0 Participant |
| cIAI:Best Available Therapy | Per-pathogen Microbiological Response of Gram-negative Pathogen at TOC by CAZ-AVI MIC in EME at TOC Analysis Set | E. coli (MIC: 0.5) - Favorable (n=0, 1, 6, 9) | 0 Participant |
| cIAI:Best Available Therapy | Per-pathogen Microbiological Response of Gram-negative Pathogen at TOC by CAZ-AVI MIC in EME at TOC Analysis Set | K. pneumoniae (MIC: >32) - Favorable (n=0,0,0,1) | 0 Participant |
| cIAI:Best Available Therapy | Per-pathogen Microbiological Response of Gram-negative Pathogen at TOC by CAZ-AVI MIC in EME at TOC Analysis Set | P. aeruginosa (MIC: >32) - Favorable (n=0,0,1,4) | 0 Participant |
| cIAI:Best Available Therapy | Per-pathogen Microbiological Response of Gram-negative Pathogen at TOC by CAZ-AVI MIC in EME at TOC Analysis Set | K. pneumoniae (MIC: 0.5) - Favorable (n=1,0,23,21) | 1 Participant |
| cIAI:Best Available Therapy | Per-pathogen Microbiological Response of Gram-negative Pathogen at TOC by CAZ-AVI MIC in EME at TOC Analysis Set | E. coli (MIC: 1) - Favorable (n=0, 0, 2, 2) | 0 Participant |
| cIAI:Best Available Therapy | Per-pathogen Microbiological Response of Gram-negative Pathogen at TOC by CAZ-AVI MIC in EME at TOC Analysis Set | E. coli (MIC: 0.06) - Favorable (n=0, 0, 3, 1) | 0 Participant |
| cIAI:Best Available Therapy | Per-pathogen Microbiological Response of Gram-negative Pathogen at TOC by CAZ-AVI MIC in EME at TOC Analysis Set | E. coli (MIC: 2) - Favorable (n=0, 0, 2, 1) | 0 Participant |
| cIAI:Best Available Therapy | Per-pathogen Microbiological Response of Gram-negative Pathogen at TOC by CAZ-AVI MIC in EME at TOC Analysis Set | K. pneumoniae (MIC: 4) - Favorable (n=0, 0, 1, 1) | 0 Participant |
| cIAI:Best Available Therapy | Per-pathogen Microbiological Response of Gram-negative Pathogen at TOC by CAZ-AVI MIC in EME at TOC Analysis Set | P. aeruginosa (MIC: 2) - Favorable (n=1, 0, 0, 1) | 1 Participant |
| cIAI:Best Available Therapy | Per-pathogen Microbiological Response of Gram-negative Pathogen at TOC by CAZ-AVI MIC in EME at TOC Analysis Set | E. coli (MIC: 8) - Favorable (n=0, 0, 2, 4) | 0 Participant |
| cIAI:Best Available Therapy | Per-pathogen Microbiological Response of Gram-negative Pathogen at TOC by CAZ-AVI MIC in EME at TOC Analysis Set | K. pneumoniae (MIC: 1) - Favorable (n=0,0,15,17) | 0 Participant |
| cIAI:Best Available Therapy | Per-pathogen Microbiological Response of Gram-negative Pathogen at TOC by CAZ-AVI MIC in EME at TOC Analysis Set | K. pneumoniae (MIC: 2) - Favorable (n=1, 1, 1, 2) | 1 Participant |
| cIAI:Best Available Therapy | Per-pathogen Microbiological Response of Gram-negative Pathogen at TOC by CAZ-AVI MIC in EME at TOC Analysis Set | K. pneumoniae (MIC: 0.06) - Favorable (n=0,0,1,0) | 0 Participant |
| cIAI:Best Available Therapy | Per-pathogen Microbiological Response of Gram-negative Pathogen at TOC by CAZ-AVI MIC in EME at TOC Analysis Set | P. aeruginosa (MIC: 8) - Favorable (n=0, 0, 0, 2) | 0 Participant |
| cIAI:Best Available Therapy | Per-pathogen Microbiological Response of Gram-negative Pathogen at TOC by CAZ-AVI MIC in EME at TOC Analysis Set | P. aeruginosa (MIC: 32) - Favorable (n=0, 0, 1, 3) | 0 Participant |
| cIAI:Best Available Therapy | Per-pathogen Microbiological Response of Gram-negative Pathogen at TOC by CAZ-AVI MIC in EME at TOC Analysis Set | K. pneumoniae (MIC: 0.12) - Favorable (n=0,0,8,5) | 0 Participant |
| cIAI:CAZ-AVI + Metronidazole | Per-pathogen Microbiological Response of Gram-negative Pathogen at TOC by CAZ-AVI MIC in EME at TOC Analysis Set | E. coli (MIC: 0.25) - Favorable (n=0, 0, 13, 15) | 0 Participant |
| cIAI:CAZ-AVI + Metronidazole | Per-pathogen Microbiological Response of Gram-negative Pathogen at TOC by CAZ-AVI MIC in EME at TOC Analysis Set | P. aeruginosa (MIC: 16) - Favorable (n=0, 1, 0, 1) | 1 Participant |
| cIAI:CAZ-AVI + Metronidazole | Per-pathogen Microbiological Response of Gram-negative Pathogen at TOC by CAZ-AVI MIC in EME at TOC Analysis Set | K. pneumoniae (MIC: 4) - Favorable (n=0, 0, 1, 1) | 0 Participant |
| cIAI:CAZ-AVI + Metronidazole | Per-pathogen Microbiological Response of Gram-negative Pathogen at TOC by CAZ-AVI MIC in EME at TOC Analysis Set | K. pneumoniae (MIC: 0.5) - Favorable (n=1,0,23,21) | 0 Participant |
| cIAI:CAZ-AVI + Metronidazole | Per-pathogen Microbiological Response of Gram-negative Pathogen at TOC by CAZ-AVI MIC in EME at TOC Analysis Set | E. coli (MIC: <=0.008) - Favorable (n=0, 0, 1, 1) | 0 Participant |
| cIAI:CAZ-AVI + Metronidazole | Per-pathogen Microbiological Response of Gram-negative Pathogen at TOC by CAZ-AVI MIC in EME at TOC Analysis Set | K. pneumoniae (MIC: 1) - Favorable (n=0,0,15,17) | 0 Participant |
| cIAI:CAZ-AVI + Metronidazole | Per-pathogen Microbiological Response of Gram-negative Pathogen at TOC by CAZ-AVI MIC in EME at TOC Analysis Set | E. coli (MIC: 1) - Favorable (n=0, 0, 2, 2) | 0 Participant |
| cIAI:CAZ-AVI + Metronidazole | Per-pathogen Microbiological Response of Gram-negative Pathogen at TOC by CAZ-AVI MIC in EME at TOC Analysis Set | K. pneumoniae (MIC: 2) - Favorable (n=1, 1, 1, 2) | 1 Participant |
| cIAI:CAZ-AVI + Metronidazole | Per-pathogen Microbiological Response of Gram-negative Pathogen at TOC by CAZ-AVI MIC in EME at TOC Analysis Set | E. coli (MIC: 0.03) - Favorable (n=0, 0, 0, 2) | 0 Participant |
| cIAI:CAZ-AVI + Metronidazole | Per-pathogen Microbiological Response of Gram-negative Pathogen at TOC by CAZ-AVI MIC in EME at TOC Analysis Set | P. aeruginosa (MIC: >32) - Favorable (n=0,0,1,4) | 0 Participant |
| cIAI:CAZ-AVI + Metronidazole | Per-pathogen Microbiological Response of Gram-negative Pathogen at TOC by CAZ-AVI MIC in EME at TOC Analysis Set | P. aeruginosa (MIC: 8) - Favorable (n=0, 0, 0, 2) | 0 Participant |
| cIAI:CAZ-AVI + Metronidazole | Per-pathogen Microbiological Response of Gram-negative Pathogen at TOC by CAZ-AVI MIC in EME at TOC Analysis Set | E. coli (MIC: 0.06) - Favorable (n=0, 0, 3, 1) | 0 Participant |
| cIAI:CAZ-AVI + Metronidazole | Per-pathogen Microbiological Response of Gram-negative Pathogen at TOC by CAZ-AVI MIC in EME at TOC Analysis Set | E. coli (MIC: 2) - Favorable (n=0, 0, 2, 1) | 0 Participant |
| cIAI:CAZ-AVI + Metronidazole | Per-pathogen Microbiological Response of Gram-negative Pathogen at TOC by CAZ-AVI MIC in EME at TOC Analysis Set | E. coli (MIC: 0.12) - Favorable (n=2, 1, 18, 18) | 1 Participant |
| cIAI:CAZ-AVI + Metronidazole | Per-pathogen Microbiological Response of Gram-negative Pathogen at TOC by CAZ-AVI MIC in EME at TOC Analysis Set | E. coli (MIC: 8) - Favorable (n=0, 0, 2, 4) | 0 Participant |
| cIAI:CAZ-AVI + Metronidazole | Per-pathogen Microbiological Response of Gram-negative Pathogen at TOC by CAZ-AVI MIC in EME at TOC Analysis Set | P. aeruginosa (MIC: 4) - Favorable (n=0, 0, 3, 2) | 0 Participant |
| cIAI:CAZ-AVI + Metronidazole | Per-pathogen Microbiological Response of Gram-negative Pathogen at TOC by CAZ-AVI MIC in EME at TOC Analysis Set | K. pneumoniae (MIC: 0.12) - Favorable (n=0,0,8,5) | 0 Participant |
| cIAI:CAZ-AVI + Metronidazole | Per-pathogen Microbiological Response of Gram-negative Pathogen at TOC by CAZ-AVI MIC in EME at TOC Analysis Set | E. coli (MIC: 0.5) - Favorable (n=0, 1, 6, 9) | 1 Participant |
| cIAI:CAZ-AVI + Metronidazole | Per-pathogen Microbiological Response of Gram-negative Pathogen at TOC by CAZ-AVI MIC in EME at TOC Analysis Set | P. aeruginosa (MIC: 2) - Favorable (n=1, 0, 0, 1) | 0 Participant |
| cIAI:CAZ-AVI + Metronidazole | Per-pathogen Microbiological Response of Gram-negative Pathogen at TOC by CAZ-AVI MIC in EME at TOC Analysis Set | K. pneumoniae (MIC: 0.25) - Favorable (n=0,2,11,6) | 2 Participant |
| cIAI:CAZ-AVI + Metronidazole | Per-pathogen Microbiological Response of Gram-negative Pathogen at TOC by CAZ-AVI MIC in EME at TOC Analysis Set | P. aeruginosa (MIC: 32) - Favorable (n=0, 0, 1, 3) | 0 Participant |
| cIAI:CAZ-AVI + Metronidazole | Per-pathogen Microbiological Response of Gram-negative Pathogen at TOC by CAZ-AVI MIC in EME at TOC Analysis Set | K. pneumoniae (MIC: >32) - Favorable (n=0,0,0,1) | 0 Participant |
| cIAI:CAZ-AVI + Metronidazole | Per-pathogen Microbiological Response of Gram-negative Pathogen at TOC by CAZ-AVI MIC in EME at TOC Analysis Set | K. pneumoniae (MIC: 0.06) - Favorable (n=0,0,1,0) | 0 Participant |
| cUTI:Best Available Therapy | Per-pathogen Microbiological Response of Gram-negative Pathogen at TOC by CAZ-AVI MIC in EME at TOC Analysis Set | P. aeruginosa (MIC: >32) - Favorable (n=0,0,1,4) | 1 Participant |
| cUTI:Best Available Therapy | Per-pathogen Microbiological Response of Gram-negative Pathogen at TOC by CAZ-AVI MIC in EME at TOC Analysis Set | E. coli (MIC: <=0.008) - Favorable (n=0, 0, 1, 1) | 1 Participant |
| cUTI:Best Available Therapy | Per-pathogen Microbiological Response of Gram-negative Pathogen at TOC by CAZ-AVI MIC in EME at TOC Analysis Set | E. coli (MIC: 0.03) - Favorable (n=0, 0, 0, 2) | 0 Participant |
| cUTI:Best Available Therapy | Per-pathogen Microbiological Response of Gram-negative Pathogen at TOC by CAZ-AVI MIC in EME at TOC Analysis Set | E. coli (MIC: 0.06) - Favorable (n=0, 0, 3, 1) | 3 Participant |
| cUTI:Best Available Therapy | Per-pathogen Microbiological Response of Gram-negative Pathogen at TOC by CAZ-AVI MIC in EME at TOC Analysis Set | E. coli (MIC: 0.12) - Favorable (n=2, 1, 18, 18) | 10 Participant |
| cUTI:Best Available Therapy | Per-pathogen Microbiological Response of Gram-negative Pathogen at TOC by CAZ-AVI MIC in EME at TOC Analysis Set | E. coli (MIC: 0.5) - Favorable (n=0, 1, 6, 9) | 4 Participant |
| cUTI:Best Available Therapy | Per-pathogen Microbiological Response of Gram-negative Pathogen at TOC by CAZ-AVI MIC in EME at TOC Analysis Set | E. coli (MIC: 1) - Favorable (n=0, 0, 2, 2) | 1 Participant |
| cUTI:Best Available Therapy | Per-pathogen Microbiological Response of Gram-negative Pathogen at TOC by CAZ-AVI MIC in EME at TOC Analysis Set | E. coli (MIC: 2) - Favorable (n=0, 0, 2, 1) | 2 Participant |
| cUTI:Best Available Therapy | Per-pathogen Microbiological Response of Gram-negative Pathogen at TOC by CAZ-AVI MIC in EME at TOC Analysis Set | E. coli (MIC: 8) - Favorable (n=0, 0, 2, 4) | 2 Participant |
| cUTI:Best Available Therapy | Per-pathogen Microbiological Response of Gram-negative Pathogen at TOC by CAZ-AVI MIC in EME at TOC Analysis Set | K. pneumoniae (MIC: 0.06) - Favorable (n=0,0,1,0) | 0 Participant |
| cUTI:Best Available Therapy | Per-pathogen Microbiological Response of Gram-negative Pathogen at TOC by CAZ-AVI MIC in EME at TOC Analysis Set | K. pneumoniae (MIC: 0.12) - Favorable (n=0,0,8,5) | 6 Participant |
| cUTI:Best Available Therapy | Per-pathogen Microbiological Response of Gram-negative Pathogen at TOC by CAZ-AVI MIC in EME at TOC Analysis Set | K. pneumoniae (MIC: 0.25) - Favorable (n=0,2,11,6) | 7 Participant |
| cUTI:Best Available Therapy | Per-pathogen Microbiological Response of Gram-negative Pathogen at TOC by CAZ-AVI MIC in EME at TOC Analysis Set | K. pneumoniae (MIC: 0.5) - Favorable (n=1,0,23,21) | 16 Participant |
| cUTI:Best Available Therapy | Per-pathogen Microbiological Response of Gram-negative Pathogen at TOC by CAZ-AVI MIC in EME at TOC Analysis Set | K. pneumoniae (MIC: 1) - Favorable (n=0,0,15,17) | 11 Participant |
| cUTI:Best Available Therapy | Per-pathogen Microbiological Response of Gram-negative Pathogen at TOC by CAZ-AVI MIC in EME at TOC Analysis Set | K. pneumoniae (MIC: 2) - Favorable (n=1, 1, 1, 2) | 1 Participant |
| cUTI:Best Available Therapy | Per-pathogen Microbiological Response of Gram-negative Pathogen at TOC by CAZ-AVI MIC in EME at TOC Analysis Set | K. pneumoniae (MIC: 4) - Favorable (n=0, 0, 1, 1) | 1 Participant |
| cUTI:Best Available Therapy | Per-pathogen Microbiological Response of Gram-negative Pathogen at TOC by CAZ-AVI MIC in EME at TOC Analysis Set | K. pneumoniae (MIC: >32) - Favorable (n=0,0,0,1) | 0 Participant |
| cUTI:Best Available Therapy | Per-pathogen Microbiological Response of Gram-negative Pathogen at TOC by CAZ-AVI MIC in EME at TOC Analysis Set | P. aeruginosa (MIC: 2) - Favorable (n=1, 0, 0, 1) | 0 Participant |
| cUTI:Best Available Therapy | Per-pathogen Microbiological Response of Gram-negative Pathogen at TOC by CAZ-AVI MIC in EME at TOC Analysis Set | P. aeruginosa (MIC: 4) - Favorable (n=0, 0, 3, 2) | 1 Participant |
| cUTI:Best Available Therapy | Per-pathogen Microbiological Response of Gram-negative Pathogen at TOC by CAZ-AVI MIC in EME at TOC Analysis Set | P. aeruginosa (MIC: 8) - Favorable (n=0, 0, 0, 2) | 0 Participant |
| cUTI:Best Available Therapy | Per-pathogen Microbiological Response of Gram-negative Pathogen at TOC by CAZ-AVI MIC in EME at TOC Analysis Set | P. aeruginosa (MIC: 16) - Favorable (n=0, 1, 0, 1) | 0 Participant |
| cUTI:Best Available Therapy | Per-pathogen Microbiological Response of Gram-negative Pathogen at TOC by CAZ-AVI MIC in EME at TOC Analysis Set | P. aeruginosa (MIC: 32) - Favorable (n=0, 0, 1, 3) | 1 Participant |
| cUTI:Best Available Therapy | Per-pathogen Microbiological Response of Gram-negative Pathogen at TOC by CAZ-AVI MIC in EME at TOC Analysis Set | E. coli (MIC: 0.25) - Favorable (n=0, 0, 13, 15) | 9 Participant |
| cUTI:CAZ-AVI | Per-pathogen Microbiological Response of Gram-negative Pathogen at TOC by CAZ-AVI MIC in EME at TOC Analysis Set | K. pneumoniae (MIC: >32) - Favorable (n=0,0,0,1) | 0 Participant |
| cUTI:CAZ-AVI | Per-pathogen Microbiological Response of Gram-negative Pathogen at TOC by CAZ-AVI MIC in EME at TOC Analysis Set | E. coli (MIC: 2) - Favorable (n=0, 0, 2, 1) | 1 Participant |
| cUTI:CAZ-AVI | Per-pathogen Microbiological Response of Gram-negative Pathogen at TOC by CAZ-AVI MIC in EME at TOC Analysis Set | E. coli (MIC: 0.5) - Favorable (n=0, 1, 6, 9) | 9 Participant |
| cUTI:CAZ-AVI | Per-pathogen Microbiological Response of Gram-negative Pathogen at TOC by CAZ-AVI MIC in EME at TOC Analysis Set | K. pneumoniae (MIC: 0.5) - Favorable (n=1,0,23,21) | 19 Participant |
| cUTI:CAZ-AVI | Per-pathogen Microbiological Response of Gram-negative Pathogen at TOC by CAZ-AVI MIC in EME at TOC Analysis Set | P. aeruginosa (MIC: 2) - Favorable (n=1, 0, 0, 1) | 1 Participant |
| cUTI:CAZ-AVI | Per-pathogen Microbiological Response of Gram-negative Pathogen at TOC by CAZ-AVI MIC in EME at TOC Analysis Set | E. coli (MIC: 0.25) - Favorable (n=0, 0, 13, 15) | 15 Participant |
| cUTI:CAZ-AVI | Per-pathogen Microbiological Response of Gram-negative Pathogen at TOC by CAZ-AVI MIC in EME at TOC Analysis Set | E. coli (MIC: 0.12) - Favorable (n=2, 1, 18, 18) | 16 Participant |
| cUTI:CAZ-AVI | Per-pathogen Microbiological Response of Gram-negative Pathogen at TOC by CAZ-AVI MIC in EME at TOC Analysis Set | E. coli (MIC: 1) - Favorable (n=0, 0, 2, 2) | 2 Participant |
| cUTI:CAZ-AVI | Per-pathogen Microbiological Response of Gram-negative Pathogen at TOC by CAZ-AVI MIC in EME at TOC Analysis Set | P. aeruginosa (MIC: 4) - Favorable (n=0, 0, 3, 2) | 1 Participant |
| cUTI:CAZ-AVI | Per-pathogen Microbiological Response of Gram-negative Pathogen at TOC by CAZ-AVI MIC in EME at TOC Analysis Set | E. coli (MIC: 0.06) - Favorable (n=0, 0, 3, 1) | 1 Participant |
| cUTI:CAZ-AVI | Per-pathogen Microbiological Response of Gram-negative Pathogen at TOC by CAZ-AVI MIC in EME at TOC Analysis Set | E. coli (MIC: 0.03) - Favorable (n=0, 0, 0, 2) | 1 Participant |
| cUTI:CAZ-AVI | Per-pathogen Microbiological Response of Gram-negative Pathogen at TOC by CAZ-AVI MIC in EME at TOC Analysis Set | P. aeruginosa (MIC: 32) - Favorable (n=0, 0, 1, 3) | 3 Participant |
| cUTI:CAZ-AVI | Per-pathogen Microbiological Response of Gram-negative Pathogen at TOC by CAZ-AVI MIC in EME at TOC Analysis Set | P. aeruginosa (MIC: 8) - Favorable (n=0, 0, 0, 2) | 2 Participant |
| cUTI:CAZ-AVI | Per-pathogen Microbiological Response of Gram-negative Pathogen at TOC by CAZ-AVI MIC in EME at TOC Analysis Set | E. coli (MIC: <=0.008) - Favorable (n=0, 0, 1, 1) | 1 Participant |
| cUTI:CAZ-AVI | Per-pathogen Microbiological Response of Gram-negative Pathogen at TOC by CAZ-AVI MIC in EME at TOC Analysis Set | P. aeruginosa (MIC: >32) - Favorable (n=0,0,1,4) | 4 Participant |
| cUTI:CAZ-AVI | Per-pathogen Microbiological Response of Gram-negative Pathogen at TOC by CAZ-AVI MIC in EME at TOC Analysis Set | K. pneumoniae (MIC: 2) - Favorable (n=1, 1, 1, 2) | 2 Participant |
| cUTI:CAZ-AVI | Per-pathogen Microbiological Response of Gram-negative Pathogen at TOC by CAZ-AVI MIC in EME at TOC Analysis Set | K. pneumoniae (MIC: 1) - Favorable (n=0,0,15,17) | 15 Participant |
| cUTI:CAZ-AVI | Per-pathogen Microbiological Response of Gram-negative Pathogen at TOC by CAZ-AVI MIC in EME at TOC Analysis Set | K. pneumoniae (MIC: 0.25) - Favorable (n=0,2,11,6) | 5 Participant |
| cUTI:CAZ-AVI | Per-pathogen Microbiological Response of Gram-negative Pathogen at TOC by CAZ-AVI MIC in EME at TOC Analysis Set | K. pneumoniae (MIC: 0.06) - Favorable (n=0,0,1,0) | 0 Participant |
| cUTI:CAZ-AVI | Per-pathogen Microbiological Response of Gram-negative Pathogen at TOC by CAZ-AVI MIC in EME at TOC Analysis Set | K. pneumoniae (MIC: 4) - Favorable (n=0, 0, 1, 1) | 0 Participant |
| cUTI:CAZ-AVI | Per-pathogen Microbiological Response of Gram-negative Pathogen at TOC by CAZ-AVI MIC in EME at TOC Analysis Set | K. pneumoniae (MIC: 0.12) - Favorable (n=0,0,8,5) | 4 Participant |
| cUTI:CAZ-AVI | Per-pathogen Microbiological Response of Gram-negative Pathogen at TOC by CAZ-AVI MIC in EME at TOC Analysis Set | E. coli (MIC: 8) - Favorable (n=0, 0, 2, 4) | 4 Participant |
| cUTI:CAZ-AVI | Per-pathogen Microbiological Response of Gram-negative Pathogen at TOC by CAZ-AVI MIC in EME at TOC Analysis Set | P. aeruginosa (MIC: 16) - Favorable (n=0, 1, 0, 1) | 0 Participant |
Secondary
Per-pathogen Microbiological Response of Gram-negative Pathogen at TOC by CAZ-AVI MIC in mMITT Analysis Set
Proportion of patients with a favorable per-pathogen microbiological response for pathogens (\>=10% of frequncy in the combined cIAI and cUTI patients): favourable microbiological response includes: Eradication Absence (or urine quantification less than 10\^4 CFU/ml for cUTI patients) of causative pathogen from an appropriately obtained specimen at the site of infection. If the patient was bacteremic at Screening, the bacteremia has also resolved. Presumed eradication where, repeat cultures were not performed/clinically indicated in a patient who had a clinical response of cure (specific to cIAI population). For E.coli, MIC available values are: \<=0.008, 0.03, 0.06, 0.12, 0.25, 0.5, 1, 2, 8. For K. pneumoniae, MIC available values are: 0.06, 0.12, 0.25, 0.5, 1, 2, 4, 32, \>32. For P. aeruginosa, MIC available values are: 2, 4, 8, 16, 32, \>32.
Time frame: 6-12 days after last infusion of study therapy. Duration of study therapy was 5 to 21 days.
Population: Microbiological modified intent to treat
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| cIAI:Best Available Therapy | Per-pathogen Microbiological Response of Gram-negative Pathogen at TOC by CAZ-AVI MIC in mMITT Analysis Set | K. pneumoniae (MIC: 1) - Favorable (n=0,0,16,18) | 0 Participant |
| cIAI:Best Available Therapy | Per-pathogen Microbiological Response of Gram-negative Pathogen at TOC by CAZ-AVI MIC in mMITT Analysis Set | K. pneumoniae (MIC: 0.5) - Favorable (n=2,0,24,22) | 1 Participant |
| cIAI:Best Available Therapy | Per-pathogen Microbiological Response of Gram-negative Pathogen at TOC by CAZ-AVI MIC in mMITT Analysis Set | E. coli (MIC: 1) - Favorable (n=0, 0, 2, 2) | 0 Participant |
| cIAI:Best Available Therapy | Per-pathogen Microbiological Response of Gram-negative Pathogen at TOC by CAZ-AVI MIC in mMITT Analysis Set | P. aeruginosa (MIC: 2) - Favorable (n=1, 0, 0, 1) | 1 Participant |
| cIAI:Best Available Therapy | Per-pathogen Microbiological Response of Gram-negative Pathogen at TOC by CAZ-AVI MIC in mMITT Analysis Set | K. pneumoniae (MIC: 0.25) - Favorable (n=0,3,12,6) | 0 Participant |
| cIAI:Best Available Therapy | Per-pathogen Microbiological Response of Gram-negative Pathogen at TOC by CAZ-AVI MIC in mMITT Analysis Set | E. coli (MIC: 0.06) - Favorable (n=1, 0, 3, 2) | 0 Participant |
| cIAI:Best Available Therapy | Per-pathogen Microbiological Response of Gram-negative Pathogen at TOC by CAZ-AVI MIC in mMITT Analysis Set | E. coli (MIC: 2) - Favorable (n=0, 0, 2, 1) | 0 Participant |
| cIAI:Best Available Therapy | Per-pathogen Microbiological Response of Gram-negative Pathogen at TOC by CAZ-AVI MIC in mMITT Analysis Set | K. pneumoniae (MIC: 32) - Favorable (n=0, 0, 1, 0) | 0 Participant |
| cIAI:Best Available Therapy | Per-pathogen Microbiological Response of Gram-negative Pathogen at TOC by CAZ-AVI MIC in mMITT Analysis Set | E. coli (MIC: 0.25) - Favorable (n=0, 0, 15, 16) | 0 Participant |
| cIAI:Best Available Therapy | Per-pathogen Microbiological Response of Gram-negative Pathogen at TOC by CAZ-AVI MIC in mMITT Analysis Set | E. coli (MIC: 8) - Favorable (n=0, 0, 2, 4) | 0 Participant |
| cIAI:Best Available Therapy | Per-pathogen Microbiological Response of Gram-negative Pathogen at TOC by CAZ-AVI MIC in mMITT Analysis Set | P. aeruginosa (MIC: 16) - Favorable (n=0, 1, 0, 1) | 0 Participant |
| cIAI:Best Available Therapy | Per-pathogen Microbiological Response of Gram-negative Pathogen at TOC by CAZ-AVI MIC in mMITT Analysis Set | K. pneumoniae (MIC: 0.12) - Favorable (n=0,1,8,5) | 0 Participant |
| cIAI:Best Available Therapy | Per-pathogen Microbiological Response of Gram-negative Pathogen at TOC by CAZ-AVI MIC in mMITT Analysis Set | K. pneumoniae (MIC: 0.06) - Favorable (n=0,0,2,0) | 0 Participant |
| cIAI:Best Available Therapy | Per-pathogen Microbiological Response of Gram-negative Pathogen at TOC by CAZ-AVI MIC in mMITT Analysis Set | K. pneumoniae (MIC: >32) - Favorable (n=0,0,0,1) | 0 Participant |
| cIAI:Best Available Therapy | Per-pathogen Microbiological Response of Gram-negative Pathogen at TOC by CAZ-AVI MIC in mMITT Analysis Set | K. pneumoniae (MIC: 4) - Favorable (n=0, 0, 1, 1) | 0 Participant |
| cIAI:Best Available Therapy | Per-pathogen Microbiological Response of Gram-negative Pathogen at TOC by CAZ-AVI MIC in mMITT Analysis Set | E. coli (MIC: 0.5) - Favorable (n=0, 1, 8, 11) | 0 Participant |
| cIAI:Best Available Therapy | Per-pathogen Microbiological Response of Gram-negative Pathogen at TOC by CAZ-AVI MIC in mMITT Analysis Set | P. aeruginosa (MIC: 32) - Favorable (n=0, 0, 1, 3) | 0 Participant |
| cIAI:Best Available Therapy | Per-pathogen Microbiological Response of Gram-negative Pathogen at TOC by CAZ-AVI MIC in mMITT Analysis Set | E. coli (MIC: <=0.008) - Favorable (n=0, 0, 1, 1) | 0 Participant |
| cIAI:Best Available Therapy | Per-pathogen Microbiological Response of Gram-negative Pathogen at TOC by CAZ-AVI MIC in mMITT Analysis Set | K. pneumoniae (MIC: 2) - Favorable (n=1, 1, 1, 2) | 1 Participant |
| cIAI:Best Available Therapy | Per-pathogen Microbiological Response of Gram-negative Pathogen at TOC by CAZ-AVI MIC in mMITT Analysis Set | P. aeruginosa (MIC: 8) - Favorable (n=0, 0, 0, 2) | 0 Participant |
| cIAI:Best Available Therapy | Per-pathogen Microbiological Response of Gram-negative Pathogen at TOC by CAZ-AVI MIC in mMITT Analysis Set | P. aeruginosa (MIC: >32) - Favorable (n=0,0,1,5) | 0 Participant |
| cIAI:Best Available Therapy | Per-pathogen Microbiological Response of Gram-negative Pathogen at TOC by CAZ-AVI MIC in mMITT Analysis Set | P. aeruginosa (MIC: 4) - Favorable (n=0, 0, 3, 2) | 0 Participant |
| cIAI:Best Available Therapy | Per-pathogen Microbiological Response of Gram-negative Pathogen at TOC by CAZ-AVI MIC in mMITT Analysis Set | E. coli (MIC: 0.12) - Favorable (n=4, 2, 20, 20) | 2 Participant |
| cIAI:Best Available Therapy | Per-pathogen Microbiological Response of Gram-negative Pathogen at TOC by CAZ-AVI MIC in mMITT Analysis Set | E. coli (MIC: 0.03) - Favorable (n=0, 0, 0, 2) | 0 Participant |
| cIAI:CAZ-AVI + Metronidazole | Per-pathogen Microbiological Response of Gram-negative Pathogen at TOC by CAZ-AVI MIC in mMITT Analysis Set | E. coli (MIC: 1) - Favorable (n=0, 0, 2, 2) | 0 Participant |
| cIAI:CAZ-AVI + Metronidazole | Per-pathogen Microbiological Response of Gram-negative Pathogen at TOC by CAZ-AVI MIC in mMITT Analysis Set | P. aeruginosa (MIC: 2) - Favorable (n=1, 0, 0, 1) | 0 Participant |
| cIAI:CAZ-AVI + Metronidazole | Per-pathogen Microbiological Response of Gram-negative Pathogen at TOC by CAZ-AVI MIC in mMITT Analysis Set | E. coli (MIC: 0.25) - Favorable (n=0, 0, 15, 16) | 0 Participant |
| cIAI:CAZ-AVI + Metronidazole | Per-pathogen Microbiological Response of Gram-negative Pathogen at TOC by CAZ-AVI MIC in mMITT Analysis Set | P. aeruginosa (MIC: 4) - Favorable (n=0, 0, 3, 2) | 0 Participant |
| cIAI:CAZ-AVI + Metronidazole | Per-pathogen Microbiological Response of Gram-negative Pathogen at TOC by CAZ-AVI MIC in mMITT Analysis Set | P. aeruginosa (MIC: 8) - Favorable (n=0, 0, 0, 2) | 0 Participant |
| cIAI:CAZ-AVI + Metronidazole | Per-pathogen Microbiological Response of Gram-negative Pathogen at TOC by CAZ-AVI MIC in mMITT Analysis Set | E. coli (MIC: <=0.008) - Favorable (n=0, 0, 1, 1) | 0 Participant |
| cIAI:CAZ-AVI + Metronidazole | Per-pathogen Microbiological Response of Gram-negative Pathogen at TOC by CAZ-AVI MIC in mMITT Analysis Set | P. aeruginosa (MIC: 16) - Favorable (n=0, 1, 0, 1) | 1 Participant |
| cIAI:CAZ-AVI + Metronidazole | Per-pathogen Microbiological Response of Gram-negative Pathogen at TOC by CAZ-AVI MIC in mMITT Analysis Set | P. aeruginosa (MIC: 32) - Favorable (n=0, 0, 1, 3) | 0 Participant |
| cIAI:CAZ-AVI + Metronidazole | Per-pathogen Microbiological Response of Gram-negative Pathogen at TOC by CAZ-AVI MIC in mMITT Analysis Set | E. coli (MIC: 0.5) - Favorable (n=0, 1, 8, 11) | 1 Participant |
| cIAI:CAZ-AVI + Metronidazole | Per-pathogen Microbiological Response of Gram-negative Pathogen at TOC by CAZ-AVI MIC in mMITT Analysis Set | P. aeruginosa (MIC: >32) - Favorable (n=0,0,1,5) | 0 Participant |
| cIAI:CAZ-AVI + Metronidazole | Per-pathogen Microbiological Response of Gram-negative Pathogen at TOC by CAZ-AVI MIC in mMITT Analysis Set | E. coli (MIC: 2) - Favorable (n=0, 0, 2, 1) | 0 Participant |
| cIAI:CAZ-AVI + Metronidazole | Per-pathogen Microbiological Response of Gram-negative Pathogen at TOC by CAZ-AVI MIC in mMITT Analysis Set | E. coli (MIC: 0.03) - Favorable (n=0, 0, 0, 2) | 0 Participant |
| cIAI:CAZ-AVI + Metronidazole | Per-pathogen Microbiological Response of Gram-negative Pathogen at TOC by CAZ-AVI MIC in mMITT Analysis Set | E. coli (MIC: 8) - Favorable (n=0, 0, 2, 4) | 0 Participant |
| cIAI:CAZ-AVI + Metronidazole | Per-pathogen Microbiological Response of Gram-negative Pathogen at TOC by CAZ-AVI MIC in mMITT Analysis Set | K. pneumoniae (MIC: 0.06) - Favorable (n=0,0,2,0) | 0 Participant |
| cIAI:CAZ-AVI + Metronidazole | Per-pathogen Microbiological Response of Gram-negative Pathogen at TOC by CAZ-AVI MIC in mMITT Analysis Set | K. pneumoniae (MIC: 0.12) - Favorable (n=0,1,8,5) | 0 Participant |
| cIAI:CAZ-AVI + Metronidazole | Per-pathogen Microbiological Response of Gram-negative Pathogen at TOC by CAZ-AVI MIC in mMITT Analysis Set | K. pneumoniae (MIC: 0.25) - Favorable (n=0,3,12,6) | 2 Participant |
| cIAI:CAZ-AVI + Metronidazole | Per-pathogen Microbiological Response of Gram-negative Pathogen at TOC by CAZ-AVI MIC in mMITT Analysis Set | E. coli (MIC: 0.06) - Favorable (n=1, 0, 3, 2) | 0 Participant |
| cIAI:CAZ-AVI + Metronidazole | Per-pathogen Microbiological Response of Gram-negative Pathogen at TOC by CAZ-AVI MIC in mMITT Analysis Set | K. pneumoniae (MIC: 0.5) - Favorable (n=2,0,24,22) | 0 Participant |
| cIAI:CAZ-AVI + Metronidazole | Per-pathogen Microbiological Response of Gram-negative Pathogen at TOC by CAZ-AVI MIC in mMITT Analysis Set | K. pneumoniae (MIC: 1) - Favorable (n=0,0,16,18) | 0 Participant |
| cIAI:CAZ-AVI + Metronidazole | Per-pathogen Microbiological Response of Gram-negative Pathogen at TOC by CAZ-AVI MIC in mMITT Analysis Set | K. pneumoniae (MIC: 2) - Favorable (n=1, 1, 1, 2) | 1 Participant |
| cIAI:CAZ-AVI + Metronidazole | Per-pathogen Microbiological Response of Gram-negative Pathogen at TOC by CAZ-AVI MIC in mMITT Analysis Set | E. coli (MIC: 0.12) - Favorable (n=4, 2, 20, 20) | 1 Participant |
| cIAI:CAZ-AVI + Metronidazole | Per-pathogen Microbiological Response of Gram-negative Pathogen at TOC by CAZ-AVI MIC in mMITT Analysis Set | K. pneumoniae (MIC: 4) - Favorable (n=0, 0, 1, 1) | 0 Participant |
| cIAI:CAZ-AVI + Metronidazole | Per-pathogen Microbiological Response of Gram-negative Pathogen at TOC by CAZ-AVI MIC in mMITT Analysis Set | K. pneumoniae (MIC: 32) - Favorable (n=0, 0, 1, 0) | 0 Participant |
| cIAI:CAZ-AVI + Metronidazole | Per-pathogen Microbiological Response of Gram-negative Pathogen at TOC by CAZ-AVI MIC in mMITT Analysis Set | K. pneumoniae (MIC: >32) - Favorable (n=0,0,0,1) | 0 Participant |
| cUTI:Best Available Therapy | Per-pathogen Microbiological Response of Gram-negative Pathogen at TOC by CAZ-AVI MIC in mMITT Analysis Set | P. aeruginosa (MIC: 8) - Favorable (n=0, 0, 0, 2) | 0 Participant |
| cUTI:Best Available Therapy | Per-pathogen Microbiological Response of Gram-negative Pathogen at TOC by CAZ-AVI MIC in mMITT Analysis Set | E. coli (MIC: <=0.008) - Favorable (n=0, 0, 1, 1) | 1 Participant |
| cUTI:Best Available Therapy | Per-pathogen Microbiological Response of Gram-negative Pathogen at TOC by CAZ-AVI MIC in mMITT Analysis Set | K. pneumoniae (MIC: >32) - Favorable (n=0,0,0,1) | 0 Participant |
| cUTI:Best Available Therapy | Per-pathogen Microbiological Response of Gram-negative Pathogen at TOC by CAZ-AVI MIC in mMITT Analysis Set | K. pneumoniae (MIC: 0.5) - Favorable (n=2,0,24,22) | 16 Participant |
| cUTI:Best Available Therapy | Per-pathogen Microbiological Response of Gram-negative Pathogen at TOC by CAZ-AVI MIC in mMITT Analysis Set | E. coli (MIC: 0.06) - Favorable (n=1, 0, 3, 2) | 3 Participant |
| cUTI:Best Available Therapy | Per-pathogen Microbiological Response of Gram-negative Pathogen at TOC by CAZ-AVI MIC in mMITT Analysis Set | E. coli (MIC: 0.5) - Favorable (n=0, 1, 8, 11) | 5 Participant |
| cUTI:Best Available Therapy | Per-pathogen Microbiological Response of Gram-negative Pathogen at TOC by CAZ-AVI MIC in mMITT Analysis Set | K. pneumoniae (MIC: 32) - Favorable (n=0, 0, 1, 0) | 0 Participant |
| cUTI:Best Available Therapy | Per-pathogen Microbiological Response of Gram-negative Pathogen at TOC by CAZ-AVI MIC in mMITT Analysis Set | P. aeruginosa (MIC: >32) - Favorable (n=0,0,1,5) | 1 Participant |
| cUTI:Best Available Therapy | Per-pathogen Microbiological Response of Gram-negative Pathogen at TOC by CAZ-AVI MIC in mMITT Analysis Set | P. aeruginosa (MIC: 32) - Favorable (n=0, 0, 1, 3) | 1 Participant |
| cUTI:Best Available Therapy | Per-pathogen Microbiological Response of Gram-negative Pathogen at TOC by CAZ-AVI MIC in mMITT Analysis Set | E. coli (MIC: 0.25) - Favorable (n=0, 0, 15, 16) | 10 Participant |
| cUTI:Best Available Therapy | Per-pathogen Microbiological Response of Gram-negative Pathogen at TOC by CAZ-AVI MIC in mMITT Analysis Set | K. pneumoniae (MIC: 2) - Favorable (n=1, 1, 1, 2) | 1 Participant |
| cUTI:Best Available Therapy | Per-pathogen Microbiological Response of Gram-negative Pathogen at TOC by CAZ-AVI MIC in mMITT Analysis Set | P. aeruginosa (MIC: 4) - Favorable (n=0, 0, 3, 2) | 1 Participant |
| cUTI:Best Available Therapy | Per-pathogen Microbiological Response of Gram-negative Pathogen at TOC by CAZ-AVI MIC in mMITT Analysis Set | P. aeruginosa (MIC: 16) - Favorable (n=0, 1, 0, 1) | 0 Participant |
| cUTI:Best Available Therapy | Per-pathogen Microbiological Response of Gram-negative Pathogen at TOC by CAZ-AVI MIC in mMITT Analysis Set | E. coli (MIC: 0.03) - Favorable (n=0, 0, 0, 2) | 0 Participant |
| cUTI:Best Available Therapy | Per-pathogen Microbiological Response of Gram-negative Pathogen at TOC by CAZ-AVI MIC in mMITT Analysis Set | P. aeruginosa (MIC: 2) - Favorable (n=1, 0, 0, 1) | 0 Participant |
| cUTI:Best Available Therapy | Per-pathogen Microbiological Response of Gram-negative Pathogen at TOC by CAZ-AVI MIC in mMITT Analysis Set | K. pneumoniae (MIC: 0.06) - Favorable (n=0,0,2,0) | 1 Participant |
| cUTI:Best Available Therapy | Per-pathogen Microbiological Response of Gram-negative Pathogen at TOC by CAZ-AVI MIC in mMITT Analysis Set | K. pneumoniae (MIC: 1) - Favorable (n=0,0,16,18) | 11 Participant |
| cUTI:Best Available Therapy | Per-pathogen Microbiological Response of Gram-negative Pathogen at TOC by CAZ-AVI MIC in mMITT Analysis Set | E. coli (MIC: 8) - Favorable (n=0, 0, 2, 4) | 2 Participant |
| cUTI:Best Available Therapy | Per-pathogen Microbiological Response of Gram-negative Pathogen at TOC by CAZ-AVI MIC in mMITT Analysis Set | K. pneumoniae (MIC: 4) - Favorable (n=0, 0, 1, 1) | 1 Participant |
| cUTI:Best Available Therapy | Per-pathogen Microbiological Response of Gram-negative Pathogen at TOC by CAZ-AVI MIC in mMITT Analysis Set | K. pneumoniae (MIC: 0.12) - Favorable (n=0,1,8,5) | 6 Participant |
| cUTI:Best Available Therapy | Per-pathogen Microbiological Response of Gram-negative Pathogen at TOC by CAZ-AVI MIC in mMITT Analysis Set | E. coli (MIC: 2) - Favorable (n=0, 0, 2, 1) | 2 Participant |
| cUTI:Best Available Therapy | Per-pathogen Microbiological Response of Gram-negative Pathogen at TOC by CAZ-AVI MIC in mMITT Analysis Set | E. coli (MIC: 1) - Favorable (n=0, 0, 2, 2) | 1 Participant |
| cUTI:Best Available Therapy | Per-pathogen Microbiological Response of Gram-negative Pathogen at TOC by CAZ-AVI MIC in mMITT Analysis Set | E. coli (MIC: 0.12) - Favorable (n=4, 2, 20, 20) | 12 Participant |
| cUTI:Best Available Therapy | Per-pathogen Microbiological Response of Gram-negative Pathogen at TOC by CAZ-AVI MIC in mMITT Analysis Set | K. pneumoniae (MIC: 0.25) - Favorable (n=0,3,12,6) | 7 Participant |
| cUTI:CAZ-AVI | Per-pathogen Microbiological Response of Gram-negative Pathogen at TOC by CAZ-AVI MIC in mMITT Analysis Set | P. aeruginosa (MIC: >32) - Favorable (n=0,0,1,5) | 4 Participant |
| cUTI:CAZ-AVI | Per-pathogen Microbiological Response of Gram-negative Pathogen at TOC by CAZ-AVI MIC in mMITT Analysis Set | E. coli (MIC: 0.06) - Favorable (n=1, 0, 3, 2) | 2 Participant |
| cUTI:CAZ-AVI | Per-pathogen Microbiological Response of Gram-negative Pathogen at TOC by CAZ-AVI MIC in mMITT Analysis Set | E. coli (MIC: <=0.008) - Favorable (n=0, 0, 1, 1) | 1 Participant |
| cUTI:CAZ-AVI | Per-pathogen Microbiological Response of Gram-negative Pathogen at TOC by CAZ-AVI MIC in mMITT Analysis Set | E. coli (MIC: 0.03) - Favorable (n=0, 0, 0, 2) | 1 Participant |
| cUTI:CAZ-AVI | Per-pathogen Microbiological Response of Gram-negative Pathogen at TOC by CAZ-AVI MIC in mMITT Analysis Set | E. coli (MIC: 0.12) - Favorable (n=4, 2, 20, 20) | 16 Participant |
| cUTI:CAZ-AVI | Per-pathogen Microbiological Response of Gram-negative Pathogen at TOC by CAZ-AVI MIC in mMITT Analysis Set | E. coli (MIC: 0.25) - Favorable (n=0, 0, 15, 16) | 15 Participant |
| cUTI:CAZ-AVI | Per-pathogen Microbiological Response of Gram-negative Pathogen at TOC by CAZ-AVI MIC in mMITT Analysis Set | E. coli (MIC: 0.5) - Favorable (n=0, 1, 8, 11) | 10 Participant |
| cUTI:CAZ-AVI | Per-pathogen Microbiological Response of Gram-negative Pathogen at TOC by CAZ-AVI MIC in mMITT Analysis Set | E. coli (MIC: 1) - Favorable (n=0, 0, 2, 2) | 2 Participant |
| cUTI:CAZ-AVI | Per-pathogen Microbiological Response of Gram-negative Pathogen at TOC by CAZ-AVI MIC in mMITT Analysis Set | E. coli (MIC: 2) - Favorable (n=0, 0, 2, 1) | 1 Participant |
| cUTI:CAZ-AVI | Per-pathogen Microbiological Response of Gram-negative Pathogen at TOC by CAZ-AVI MIC in mMITT Analysis Set | E. coli (MIC: 8) - Favorable (n=0, 0, 2, 4) | 4 Participant |
| cUTI:CAZ-AVI | Per-pathogen Microbiological Response of Gram-negative Pathogen at TOC by CAZ-AVI MIC in mMITT Analysis Set | K. pneumoniae (MIC: 0.06) - Favorable (n=0,0,2,0) | 0 Participant |
| cUTI:CAZ-AVI | Per-pathogen Microbiological Response of Gram-negative Pathogen at TOC by CAZ-AVI MIC in mMITT Analysis Set | K. pneumoniae (MIC: 0.12) - Favorable (n=0,1,8,5) | 4 Participant |
| cUTI:CAZ-AVI | Per-pathogen Microbiological Response of Gram-negative Pathogen at TOC by CAZ-AVI MIC in mMITT Analysis Set | K. pneumoniae (MIC: 0.25) - Favorable (n=0,3,12,6) | 5 Participant |
| cUTI:CAZ-AVI | Per-pathogen Microbiological Response of Gram-negative Pathogen at TOC by CAZ-AVI MIC in mMITT Analysis Set | K. pneumoniae (MIC: 0.5) - Favorable (n=2,0,24,22) | 19 Participant |
| cUTI:CAZ-AVI | Per-pathogen Microbiological Response of Gram-negative Pathogen at TOC by CAZ-AVI MIC in mMITT Analysis Set | K. pneumoniae (MIC: 1) - Favorable (n=0,0,16,18) | 16 Participant |
| cUTI:CAZ-AVI | Per-pathogen Microbiological Response of Gram-negative Pathogen at TOC by CAZ-AVI MIC in mMITT Analysis Set | K. pneumoniae (MIC: 2) - Favorable (n=1, 1, 1, 2) | 1 Participant |
| cUTI:CAZ-AVI | Per-pathogen Microbiological Response of Gram-negative Pathogen at TOC by CAZ-AVI MIC in mMITT Analysis Set | K. pneumoniae (MIC: 4) - Favorable (n=0, 0, 1, 1) | 0 Participant |
| cUTI:CAZ-AVI | Per-pathogen Microbiological Response of Gram-negative Pathogen at TOC by CAZ-AVI MIC in mMITT Analysis Set | K. pneumoniae (MIC: 32) - Favorable (n=0, 0, 1, 0) | 0 Participant |
| cUTI:CAZ-AVI | Per-pathogen Microbiological Response of Gram-negative Pathogen at TOC by CAZ-AVI MIC in mMITT Analysis Set | K. pneumoniae (MIC: >32) - Favorable (n=0,0,0,1) | 0 Participant |
| cUTI:CAZ-AVI | Per-pathogen Microbiological Response of Gram-negative Pathogen at TOC by CAZ-AVI MIC in mMITT Analysis Set | P. aeruginosa (MIC: 2) - Favorable (n=1, 0, 0, 1) | 1 Participant |
| cUTI:CAZ-AVI | Per-pathogen Microbiological Response of Gram-negative Pathogen at TOC by CAZ-AVI MIC in mMITT Analysis Set | P. aeruginosa (MIC: 4) - Favorable (n=0, 0, 3, 2) | 1 Participant |
| cUTI:CAZ-AVI | Per-pathogen Microbiological Response of Gram-negative Pathogen at TOC by CAZ-AVI MIC in mMITT Analysis Set | P. aeruginosa (MIC: 8) - Favorable (n=0, 0, 0, 2) | 2 Participant |
| cUTI:CAZ-AVI | Per-pathogen Microbiological Response of Gram-negative Pathogen at TOC by CAZ-AVI MIC in mMITT Analysis Set | P. aeruginosa (MIC: 16) - Favorable (n=0, 1, 0, 1) | 0 Participant |
| cUTI:CAZ-AVI | Per-pathogen Microbiological Response of Gram-negative Pathogen at TOC by CAZ-AVI MIC in mMITT Analysis Set | P. aeruginosa (MIC: 32) - Favorable (n=0, 0, 1, 3) | 3 Participant |
Secondary
Per-pathogen Microbiological Response of Gram-negative Pathogen at TOC in EME at TOC Analysis Set
Proportion of patients with a favorable per-pathogen microbiological response for pathogens (\>=10% of frequncy in the combined cIAI and cUTI patients): favourable microbiological response includes: Eradication Absence (or urine quantification less than 10\^4 CFU/ml for cUTI patients) of causative pathogen from an appropriately obtained specimen at the site of infection. If the patient was bacteremic at Screening, the bacteremia has also resolved. Presumed eradication where, repeat cultures were not performed/clinically indicated in a patient who had a clinical response of cure (specific to cIAI population).
Time frame: 6-12 days after last infusion of study therapy. Duration of study therapy was 5 to 21 days.
Population: Extended microbiologically evaluable at TOC
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| cIAI:Best Available Therapy | Per-pathogen Microbiological Response of Gram-negative Pathogen at TOC in EME at TOC Analysis Set | Pseudo. aeruginosa - Favorable (n=1, 1, 5, 13) | 1 Participant |
| cIAI:Best Available Therapy | Per-pathogen Microbiological Response of Gram-negative Pathogen at TOC in EME at TOC Analysis Set | Escherichia coli - Unfavorable (n=2, 3, 49, 53) | 0 Participant |
| cIAI:Best Available Therapy | Per-pathogen Microbiological Response of Gram-negative Pathogen at TOC in EME at TOC Analysis Set | Kleb. pneumoniae - Unfavorable (n=2, 3, 60, 53) | 0 Participant |
| cIAI:Best Available Therapy | Per-pathogen Microbiological Response of Gram-negative Pathogen at TOC in EME at TOC Analysis Set | Escherichia coli - Favorable (n=2, 3, 49, 53) | 2 Participant |
| cIAI:Best Available Therapy | Per-pathogen Microbiological Response of Gram-negative Pathogen at TOC in EME at TOC Analysis Set | Pseudo. aeruginosa - Unfavorable (n=1, 1, 5, 13) | 0 Participant |
| cIAI:Best Available Therapy | Per-pathogen Microbiological Response of Gram-negative Pathogen at TOC in EME at TOC Analysis Set | Kleb. pneumoniae - Favorable (n=2, 3, 60, 53) | 2 Participant |
| cIAI:CAZ-AVI + Metronidazole | Per-pathogen Microbiological Response of Gram-negative Pathogen at TOC in EME at TOC Analysis Set | Pseudo. aeruginosa - Unfavorable (n=1, 1, 5, 13) | 0 Participant |
| cIAI:CAZ-AVI + Metronidazole | Per-pathogen Microbiological Response of Gram-negative Pathogen at TOC in EME at TOC Analysis Set | Kleb. pneumoniae - Unfavorable (n=2, 3, 60, 53) | 0 Participant |
| cIAI:CAZ-AVI + Metronidazole | Per-pathogen Microbiological Response of Gram-negative Pathogen at TOC in EME at TOC Analysis Set | Escherichia coli - Favorable (n=2, 3, 49, 53) | 3 Participant |
| cIAI:CAZ-AVI + Metronidazole | Per-pathogen Microbiological Response of Gram-negative Pathogen at TOC in EME at TOC Analysis Set | Kleb. pneumoniae - Favorable (n=2, 3, 60, 53) | 3 Participant |
| cIAI:CAZ-AVI + Metronidazole | Per-pathogen Microbiological Response of Gram-negative Pathogen at TOC in EME at TOC Analysis Set | Pseudo. aeruginosa - Favorable (n=1, 1, 5, 13) | 1 Participant |
| cIAI:CAZ-AVI + Metronidazole | Per-pathogen Microbiological Response of Gram-negative Pathogen at TOC in EME at TOC Analysis Set | Escherichia coli - Unfavorable (n=2, 3, 49, 53) | 0 Participant |
| cUTI:Best Available Therapy | Per-pathogen Microbiological Response of Gram-negative Pathogen at TOC in EME at TOC Analysis Set | Pseudo. aeruginosa - Unfavorable (n=1, 1, 5, 13) | 2 Participant |
| cUTI:Best Available Therapy | Per-pathogen Microbiological Response of Gram-negative Pathogen at TOC in EME at TOC Analysis Set | Kleb. pneumoniae - Favorable (n=2, 3, 60, 53) | 42 Participant |
| cUTI:Best Available Therapy | Per-pathogen Microbiological Response of Gram-negative Pathogen at TOC in EME at TOC Analysis Set | Escherichia coli - Favorable (n=2, 3, 49, 53) | 34 Participant |
| cUTI:Best Available Therapy | Per-pathogen Microbiological Response of Gram-negative Pathogen at TOC in EME at TOC Analysis Set | Escherichia coli - Unfavorable (n=2, 3, 49, 53) | 15 Participant |
| cUTI:Best Available Therapy | Per-pathogen Microbiological Response of Gram-negative Pathogen at TOC in EME at TOC Analysis Set | Kleb. pneumoniae - Unfavorable (n=2, 3, 60, 53) | 18 Participant |
| cUTI:Best Available Therapy | Per-pathogen Microbiological Response of Gram-negative Pathogen at TOC in EME at TOC Analysis Set | Pseudo. aeruginosa - Favorable (n=1, 1, 5, 13) | 3 Participant |
| cUTI:CAZ-AVI | Per-pathogen Microbiological Response of Gram-negative Pathogen at TOC in EME at TOC Analysis Set | Kleb. pneumoniae - Favorable (n=2, 3, 60, 53) | 45 Participant |
| cUTI:CAZ-AVI | Per-pathogen Microbiological Response of Gram-negative Pathogen at TOC in EME at TOC Analysis Set | Pseudo. aeruginosa - Unfavorable (n=1, 1, 5, 13) | 2 Participant |
| cUTI:CAZ-AVI | Per-pathogen Microbiological Response of Gram-negative Pathogen at TOC in EME at TOC Analysis Set | Pseudo. aeruginosa - Favorable (n=1, 1, 5, 13) | 11 Participant |
| cUTI:CAZ-AVI | Per-pathogen Microbiological Response of Gram-negative Pathogen at TOC in EME at TOC Analysis Set | Escherichia coli - Unfavorable (n=2, 3, 49, 53) | 3 Participant |
| cUTI:CAZ-AVI | Per-pathogen Microbiological Response of Gram-negative Pathogen at TOC in EME at TOC Analysis Set | Escherichia coli - Favorable (n=2, 3, 49, 53) | 50 Participant |
| cUTI:CAZ-AVI | Per-pathogen Microbiological Response of Gram-negative Pathogen at TOC in EME at TOC Analysis Set | Kleb. pneumoniae - Unfavorable (n=2, 3, 60, 53) | 8 Participant |
Secondary
Per-pathogen Microbiological Response of Gram-negative Pathogen at TOC in mMITT Analysis Set
Proportion of patients with a favorable per-pathogen microbiological response for pathogens (\>=10% of frequency in the combined cIAI and cUTI patients): favourable microbiological response includes: Eradication Absence (or urine quantification less than 10\^4 CFU/ml for cUTI patients) of causative pathogen from an appropriately obtained specimen at the site of infection. If the patient was bacteremic at Screening, the bacteremia has also resolved. Presumed eradication where, repeat cultures were not performed/clinically indicated in a patient who had a clinical response of cure (specific to cIAI population).
Time frame: 6-12 days after last infusion of study therapy. Duration of study therapy was 5 to 21 days.
Population: Microbiological modified intent to treat
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| cIAI:Best Available Therapy | Per-pathogen Microbiological Response of Gram-negative Pathogen at TOC in mMITT Analysis Set | Pseudo. aeruginosa - Favorable (n=1, 1, 5, 14) | 1 Participant |
| cIAI:Best Available Therapy | Per-pathogen Microbiological Response of Gram-negative Pathogen at TOC in mMITT Analysis Set | Kleb. pneumoniae - Indeterminate (n=3, 5, 65, 55) | 1 Participant |
| cIAI:Best Available Therapy | Per-pathogen Microbiological Response of Gram-negative Pathogen at TOC in mMITT Analysis Set | Pseudo. aeruginosa - Indeterminate (n=1, 1, 5, 14) | 0 Participant |
| cIAI:Best Available Therapy | Per-pathogen Microbiological Response of Gram-negative Pathogen at TOC in mMITT Analysis Set | Kleb. pneumoniae - Favorable (n=3, 5, 65, 55) | 2 Participant |
| cIAI:Best Available Therapy | Per-pathogen Microbiological Response of Gram-negative Pathogen at TOC in mMITT Analysis Set | Escherichia coli - Indeterminate (n=6, 4, 57, 59) | 4 Participant |
| cIAI:Best Available Therapy | Per-pathogen Microbiological Response of Gram-negative Pathogen at TOC in mMITT Analysis Set | Escherichia coli - Unfavorable (n=6, 4, 57, 59) | 0 Participant |
| cIAI:Best Available Therapy | Per-pathogen Microbiological Response of Gram-negative Pathogen at TOC in mMITT Analysis Set | Pseudo. aeruginosa - Unfavorable (n=1, 1, 5, 14) | 0 Participant |
| cIAI:Best Available Therapy | Per-pathogen Microbiological Response of Gram-negative Pathogen at TOC in mMITT Analysis Set | Kleb. pneumoniae - Unfavorable (n=3, 5, 65, 55) | 0 Participant |
| cIAI:Best Available Therapy | Per-pathogen Microbiological Response of Gram-negative Pathogen at TOC in mMITT Analysis Set | Escherichia coli - Favorable (n=6, 4, 57, 59) | 2 Participant |
| cIAI:CAZ-AVI + Metronidazole | Per-pathogen Microbiological Response of Gram-negative Pathogen at TOC in mMITT Analysis Set | Kleb. pneumoniae - Unfavorable (n=3, 5, 65, 55) | 0 Participant |
| cIAI:CAZ-AVI + Metronidazole | Per-pathogen Microbiological Response of Gram-negative Pathogen at TOC in mMITT Analysis Set | Pseudo. aeruginosa - Favorable (n=1, 1, 5, 14) | 1 Participant |
| cIAI:CAZ-AVI + Metronidazole | Per-pathogen Microbiological Response of Gram-negative Pathogen at TOC in mMITT Analysis Set | Kleb. pneumoniae - Indeterminate (n=3, 5, 65, 55) | 2 Participant |
| cIAI:CAZ-AVI + Metronidazole | Per-pathogen Microbiological Response of Gram-negative Pathogen at TOC in mMITT Analysis Set | Escherichia coli - Unfavorable (n=6, 4, 57, 59) | 0 Participant |
| cIAI:CAZ-AVI + Metronidazole | Per-pathogen Microbiological Response of Gram-negative Pathogen at TOC in mMITT Analysis Set | Escherichia coli - Favorable (n=6, 4, 57, 59) | 3 Participant |
| cIAI:CAZ-AVI + Metronidazole | Per-pathogen Microbiological Response of Gram-negative Pathogen at TOC in mMITT Analysis Set | Escherichia coli - Indeterminate (n=6, 4, 57, 59) | 1 Participant |
| cIAI:CAZ-AVI + Metronidazole | Per-pathogen Microbiological Response of Gram-negative Pathogen at TOC in mMITT Analysis Set | Pseudo. aeruginosa - Indeterminate (n=1, 1, 5, 14) | 0 Participant |
| cIAI:CAZ-AVI + Metronidazole | Per-pathogen Microbiological Response of Gram-negative Pathogen at TOC in mMITT Analysis Set | Pseudo. aeruginosa - Unfavorable (n=1, 1, 5, 14) | 0 Participant |
| cIAI:CAZ-AVI + Metronidazole | Per-pathogen Microbiological Response of Gram-negative Pathogen at TOC in mMITT Analysis Set | Kleb. pneumoniae - Favorable (n=3, 5, 65, 55) | 3 Participant |
| cUTI:Best Available Therapy | Per-pathogen Microbiological Response of Gram-negative Pathogen at TOC in mMITT Analysis Set | Kleb. pneumoniae - Unfavorable (n=3, 5, 65, 55) | 19 Participant |
| cUTI:Best Available Therapy | Per-pathogen Microbiological Response of Gram-negative Pathogen at TOC in mMITT Analysis Set | Escherichia coli - Favorable (n=6, 4, 57, 59) | 38 Participant |
| cUTI:Best Available Therapy | Per-pathogen Microbiological Response of Gram-negative Pathogen at TOC in mMITT Analysis Set | Escherichia coli - Unfavorable (n=6, 4, 57, 59) | 16 Participant |
| cUTI:Best Available Therapy | Per-pathogen Microbiological Response of Gram-negative Pathogen at TOC in mMITT Analysis Set | Escherichia coli - Indeterminate (n=6, 4, 57, 59) | 3 Participant |
| cUTI:Best Available Therapy | Per-pathogen Microbiological Response of Gram-negative Pathogen at TOC in mMITT Analysis Set | Kleb. pneumoniae - Favorable (n=3, 5, 65, 55) | 43 Participant |
| cUTI:Best Available Therapy | Per-pathogen Microbiological Response of Gram-negative Pathogen at TOC in mMITT Analysis Set | Kleb. pneumoniae - Indeterminate (n=3, 5, 65, 55) | 3 Participant |
| cUTI:Best Available Therapy | Per-pathogen Microbiological Response of Gram-negative Pathogen at TOC in mMITT Analysis Set | Pseudo. aeruginosa - Favorable (n=1, 1, 5, 14) | 3 Participant |
| cUTI:Best Available Therapy | Per-pathogen Microbiological Response of Gram-negative Pathogen at TOC in mMITT Analysis Set | Pseudo. aeruginosa - Unfavorable (n=1, 1, 5, 14) | 2 Participant |
| cUTI:Best Available Therapy | Per-pathogen Microbiological Response of Gram-negative Pathogen at TOC in mMITT Analysis Set | Pseudo. aeruginosa - Indeterminate (n=1, 1, 5, 14) | 0 Participant |
| cUTI:CAZ-AVI | Per-pathogen Microbiological Response of Gram-negative Pathogen at TOC in mMITT Analysis Set | Pseudo. aeruginosa - Favorable (n=1, 1, 5, 14) | 11 Participant |
| cUTI:CAZ-AVI | Per-pathogen Microbiological Response of Gram-negative Pathogen at TOC in mMITT Analysis Set | Kleb. pneumoniae - Favorable (n=3, 5, 65, 55) | 46 Participant |
| cUTI:CAZ-AVI | Per-pathogen Microbiological Response of Gram-negative Pathogen at TOC in mMITT Analysis Set | Escherichia coli - Indeterminate (n=6, 4, 57, 59) | 4 Participant |
| cUTI:CAZ-AVI | Per-pathogen Microbiological Response of Gram-negative Pathogen at TOC in mMITT Analysis Set | Pseudo. aeruginosa - Indeterminate (n=1, 1, 5, 14) | 1 Participant |
| cUTI:CAZ-AVI | Per-pathogen Microbiological Response of Gram-negative Pathogen at TOC in mMITT Analysis Set | Pseudo. aeruginosa - Unfavorable (n=1, 1, 5, 14) | 2 Participant |
| cUTI:CAZ-AVI | Per-pathogen Microbiological Response of Gram-negative Pathogen at TOC in mMITT Analysis Set | Escherichia coli - Unfavorable (n=6, 4, 57, 59) | 3 Participant |
| cUTI:CAZ-AVI | Per-pathogen Microbiological Response of Gram-negative Pathogen at TOC in mMITT Analysis Set | Kleb. pneumoniae - Indeterminate (n=3, 5, 65, 55) | 1 Participant |
| cUTI:CAZ-AVI | Per-pathogen Microbiological Response of Gram-negative Pathogen at TOC in mMITT Analysis Set | Kleb. pneumoniae - Unfavorable (n=3, 5, 65, 55) | 8 Participant |
| cUTI:CAZ-AVI | Per-pathogen Microbiological Response of Gram-negative Pathogen at TOC in mMITT Analysis Set | Escherichia coli - Favorable (n=6, 4, 57, 59) | 52 Participant |
Secondary
Per-patient Microbiological Response at EOT in EME at EOT Analysis Set
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 cIAI patients where the clinical response was changed to indeterminate due to a Surgical Review Panel assessment of inadequate source control (ie, circumstances that preclude classification as eradication, presumed eradication, persistence, persistence with increasing MIC, and presumed persistence).
Time frame: 28 hours after completion of last infusion of study therapy. Duration of study therapy was 5 to 21 days.
Population: Extended microbiologically evaluable at EOT
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| cIAI:Best Available Therapy | Per-patient Microbiological Response at EOT in EME at EOT Analysis Set | Favorable | 5 Participant |
| cIAI:Best Available Therapy | Per-patient Microbiological Response at EOT in EME at EOT Analysis Set | Unfavorable | 0 Participant |
| cIAI:CAZ-AVI + Metronidazole | Per-patient Microbiological Response at EOT in EME at EOT Analysis Set | Unfavorable | 0 Participant |
| cIAI:CAZ-AVI + Metronidazole | Per-patient Microbiological Response at EOT in EME at EOT Analysis Set | Favorable | 9 Participant |
| cUTI:Best Available Therapy | Per-patient Microbiological Response at EOT in EME at EOT Analysis Set | Favorable | 127 Participant |
| cUTI:Best Available Therapy | Per-patient Microbiological Response at EOT in EME at EOT Analysis Set | Unfavorable | 0 Participant |
| cUTI:CAZ-AVI | Per-patient Microbiological Response at EOT in EME at EOT Analysis Set | Favorable | 133 Participant |
| cUTI:CAZ-AVI | Per-patient Microbiological Response at EOT in EME at EOT Analysis Set | Unfavorable | 1 Participant |
Secondary
Per-patient Microbiological Response at EOT in mMITT Analysis Set
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 cIAI patients where the clinical response was changed to indeterminate due to a Surgical Review Panel assessment of inadequate source control (ie, circumstances that preclude classification as eradication, presumed eradication, persistence, persistence with increasing MIC, and presumed persistence).
Time frame: 28 hours after completion of last infusion of study therapy. Duration of study therapy was 5 to 21 days.
Population: Microbiological modified intent to treat
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| cIAI:Best Available Therapy | Per-patient Microbiological Response at EOT in mMITT Analysis Set | Indeterminate | 5 Participant |
| cIAI:Best Available Therapy | Per-patient Microbiological Response at EOT in mMITT Analysis Set | Unfavorable | 0 Participant |
| cIAI:Best Available Therapy | Per-patient Microbiological Response at EOT in mMITT Analysis Set | Favorable | 6 Participant |
| cIAI:CAZ-AVI + Metronidazole | Per-patient Microbiological Response at EOT in mMITT Analysis Set | Unfavorable | 0 Participant |
| cIAI:CAZ-AVI + Metronidazole | Per-patient Microbiological Response at EOT in mMITT Analysis Set | Indeterminate | 1 Participant |
| cIAI:CAZ-AVI + Metronidazole | Per-patient Microbiological Response at EOT in mMITT Analysis Set | Favorable | 9 Participant |
| cUTI:Best Available Therapy | Per-patient Microbiological Response at EOT in mMITT Analysis Set | Unfavorable | 1 Participant |
| cUTI:Best Available Therapy | Per-patient Microbiological Response at EOT in mMITT Analysis Set | Favorable | 130 Participant |
| cUTI:Best Available Therapy | Per-patient Microbiological Response at EOT in mMITT Analysis Set | Indeterminate | 6 Participant |
| cUTI:CAZ-AVI | Per-patient Microbiological Response at EOT in mMITT Analysis Set | Indeterminate | 7 Participant |
| cUTI:CAZ-AVI | Per-patient Microbiological Response at EOT in mMITT Analysis Set | Unfavorable | 1 Participant |
| cUTI:CAZ-AVI | Per-patient Microbiological Response at EOT in mMITT Analysis Set | Favorable | 136 Participant |
Secondary
Per-patient Microbiological Response at FU1 in EME at FU1 Analysis Set
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 cIAI patients where the clinical response was changed to indeterminate due to a Surgical Review Panel assessment of inadequate source control (ie, circumstances that preclude classification as eradication, presumed eradication, persistence, persistence with increasing MIC, and presumed persistence).
Time frame: cUTI: 20-27 calendar days from randomization/cIAI: 27-37 calendar days from randomization
Population: Extended microbiologically evaluable at FU1
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| cIAI:Best Available Therapy | Per-patient Microbiological Response at FU1 in EME at FU1 Analysis Set | Favorable | 5 Participant |
| cIAI:Best Available Therapy | Per-patient Microbiological Response at FU1 in EME at FU1 Analysis Set | Unfavorable | 0 Participant |
| cIAI:CAZ-AVI + Metronidazole | Per-patient Microbiological Response at FU1 in EME at FU1 Analysis Set | Unfavorable | 0 Participant |
| cIAI:CAZ-AVI + Metronidazole | Per-patient Microbiological Response at FU1 in EME at FU1 Analysis Set | Favorable | 7 Participant |
| cUTI:Best Available Therapy | Per-patient Microbiological Response at FU1 in EME at FU1 Analysis Set | Favorable | 75 Participant |
| cUTI:Best Available Therapy | Per-patient Microbiological Response at FU1 in EME at FU1 Analysis Set | Unfavorable | 45 Participant |
| cUTI:CAZ-AVI | Per-patient Microbiological Response at FU1 in EME at FU1 Analysis Set | Favorable | 98 Participant |
| cUTI:CAZ-AVI | Per-patient Microbiological Response at FU1 in EME at FU1 Analysis Set | Unfavorable | 28 Participant |
Secondary
Per-patient Microbiological Response at FU1 in mMITT Analysis Set
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 cIAI patients where the clinical response was changed to indeterminate due to a Surgical Review Panel assessment of inadequate source control (ie, circumstances that preclude classification as eradication, presumed eradication, persistence, persistence with increasing MIC, and presumed persistence).
Time frame: cUTI: 20-27 calendar days from randomization/cIAI: 27-37 calendar days from randomization
Population: Microbiological modified intent to treat
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| cIAI:Best Available Therapy | Per-patient Microbiological Response at FU1 in mMITT Analysis Set | Unfavorable | 0 Participant |
| cIAI:Best Available Therapy | Per-patient Microbiological Response at FU1 in mMITT Analysis Set | Indeterminate | 5 Participant |
| cIAI:Best Available Therapy | Per-patient Microbiological Response at FU1 in mMITT Analysis Set | Favorable | 6 Participant |
| cIAI:CAZ-AVI + Metronidazole | Per-patient Microbiological Response at FU1 in mMITT Analysis Set | Favorable | 8 Participant |
| cIAI:CAZ-AVI + Metronidazole | Per-patient Microbiological Response at FU1 in mMITT Analysis Set | Unfavorable | 0 Participant |
| cIAI:CAZ-AVI + Metronidazole | Per-patient Microbiological Response at FU1 in mMITT Analysis Set | Indeterminate | 2 Participant |
| cUTI:Best Available Therapy | Per-patient Microbiological Response at FU1 in mMITT Analysis Set | Indeterminate | 9 Participant |
| cUTI:Best Available Therapy | Per-patient Microbiological Response at FU1 in mMITT Analysis Set | Unfavorable | 50 Participant |
| cUTI:Best Available Therapy | Per-patient Microbiological Response at FU1 in mMITT Analysis Set | Favorable | 78 Participant |
| cUTI:CAZ-AVI | Per-patient Microbiological Response at FU1 in mMITT Analysis Set | Unfavorable | 29 Participant |
| cUTI:CAZ-AVI | Per-patient Microbiological Response at FU1 in mMITT Analysis Set | Indeterminate | 12 Participant |
| cUTI:CAZ-AVI | Per-patient Microbiological Response at FU1 in mMITT Analysis Set | Favorable | 103 Participant |
Secondary
Per-patient Microbiological Response at FU2 in EME at FU2 Analysis Set
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 cIAI patients where the clinical response was changed to indeterminate due to a Surgical Review Panel 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 FU2, data was only collected for the cUTI Arms: 28-34 calendar days from randomization
Population: Extended microbiologically evaluable at FU2
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| cUTI:Best Available Therapy | Per-patient Microbiological Response at FU2 in EME at FU2 Analysis Set | Favorable | 68 Participant |
| cUTI:Best Available Therapy | Per-patient Microbiological Response at FU2 in EME at FU2 Analysis Set | Unfavorable | 47 Participant |
| cUTI:CAZ-AVI | Per-patient Microbiological Response at FU2 in EME at FU2 Analysis Set | Favorable | 85 Participant |
| cUTI:CAZ-AVI | Per-patient Microbiological Response at FU2 in EME at FU2 Analysis Set | Unfavorable | 32 Participant |
Secondary
Per-patient Microbiological Response at FU2 in mMITT Analysis Set
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 cIAI patients where the clinical response was changed to indeterminate due to a Surgical Review Panel 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 FU2, data was only collected for the cUTI Arms: 28-34 calendar days from randomization
Population: Microbiological modified intent to treat
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| cUTI:Best Available Therapy | Per-patient Microbiological Response at FU2 in mMITT Analysis Set | Unfavorable | 54 Participant |
| cUTI:Best Available Therapy | Per-patient Microbiological Response at FU2 in mMITT Analysis Set | Favorable | 73 Participant |
| cUTI:Best Available Therapy | Per-patient Microbiological Response at FU2 in mMITT Analysis Set | Indeterminate | 10 Participant |
| cUTI:CAZ-AVI | Per-patient Microbiological Response at FU2 in mMITT Analysis Set | Favorable | 99 Participant |
| cUTI:CAZ-AVI | Per-patient Microbiological Response at FU2 in mMITT Analysis Set | Unfavorable | 35 Participant |
| cUTI:CAZ-AVI | Per-patient Microbiological Response at FU2 in mMITT Analysis Set | Indeterminate | 10 Participant |
Secondary
Per-patient Microbiological Response at TOC in EME at TOC Analysis Set
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 cIAI patients where the clinical response was changed to indeterminate due to a Surgical Review Panel assessment of inadequate source control (ie, circumstances that preclude classification as eradication, presumed eradication, persistence, persistence with increasing MIC, and presumed persistence).
Time frame: 6-12 days after last infusion of study therapy.Duration of study therapy was 5 to 21 days.
Population: Extended microbiologically evaluable at TOC
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| cIAI:Best Available Therapy | Per-patient Microbiological Response at TOC in EME at TOC Analysis Set | Favorable | 5 Participant |
| cIAI:Best Available Therapy | Per-patient Microbiological Response at TOC in EME at TOC Analysis Set | Unfavorable | 0 Participant |
| cIAI:CAZ-AVI + Metronidazole | Per-patient Microbiological Response at TOC in EME at TOC Analysis Set | Unfavorable | 0 Participant |
| cIAI:CAZ-AVI + Metronidazole | Per-patient Microbiological Response at TOC in EME at TOC Analysis Set | Favorable | 8 Participant |
| cUTI:Best Available Therapy | Per-patient Microbiological Response at TOC in EME at TOC Analysis Set | Favorable | 84 Participant |
| cUTI:Best Available Therapy | Per-patient Microbiological Response at TOC in EME at TOC Analysis Set | Unfavorable | 40 Participant |
| cUTI:CAZ-AVI | Per-patient Microbiological Response at TOC in EME at TOC Analysis Set | Favorable | 114 Participant |
| cUTI:CAZ-AVI | Per-patient Microbiological Response at TOC in EME at TOC Analysis Set | Unfavorable | 17 Participant |
Secondary
Per-patient Microbiological Response at TOC in mMITT Analysis Set
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 cIAI patients where the clinical response was changed to indeterminate due to a Surgical Review Panel assessment of inadequate source control (ie, circumstances that preclude classification as eradication, presumed eradication, persistence, persistence with increasing MIC, and presumed persistence).
Time frame: 6-12 days after last infusion of study therapy. Duration of study therapy was 5 to 21 days.
Population: Microbiological modified intent to treat
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| cIAI:Best Available Therapy | Per-patient Microbiological Response at TOC in mMITT Analysis Set | Indeterminate | 5 Participant |
| cIAI:Best Available Therapy | Per-patient Microbiological Response at TOC in mMITT Analysis Set | Unfavorable | 0 Participant |
| cIAI:Best Available Therapy | Per-patient Microbiological Response at TOC in mMITT Analysis Set | Favorable | 6 Participant |
| cIAI:CAZ-AVI + Metronidazole | Per-patient Microbiological Response at TOC in mMITT Analysis Set | Indeterminate | 2 Participant |
| cIAI:CAZ-AVI + Metronidazole | Per-patient Microbiological Response at TOC in mMITT Analysis Set | Favorable | 8 Participant |
| cIAI:CAZ-AVI + Metronidazole | Per-patient Microbiological Response at TOC in mMITT Analysis Set | Unfavorable | 0 Participant |
| cUTI:Best Available Therapy | Per-patient Microbiological Response at TOC in mMITT Analysis Set | Unfavorable | 42 Participant |
| cUTI:Best Available Therapy | Per-patient Microbiological Response at TOC in mMITT Analysis Set | Favorable | 88 Participant |
| cUTI:Best Available Therapy | Per-patient Microbiological Response at TOC in mMITT Analysis Set | Indeterminate | 7 Participant |
| cUTI:CAZ-AVI | Per-patient Microbiological Response at TOC in mMITT Analysis Set | Indeterminate | 9 Participant |
| cUTI:CAZ-AVI | Per-patient Microbiological Response at TOC in mMITT Analysis Set | Unfavorable | 17 Participant |
| cUTI:CAZ-AVI | Per-patient Microbiological Response at TOC in mMITT Analysis Set | Favorable | 118 Participant |
Secondary
Plasma Concentrations for Ceftazidime and Avibactam - cIAI in PK Analysis Set
Blood samples were taken on Day 3 for ceftazidime and avibactam plasma concentration.
Time frame: Anytime within 15 minutes prior to or after stopping study drug, anytime between 30 to 90 minutes after stopping study drug, anytime between 300 to 360 minutes after stopping study drug
Population: PK Analysis set
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| cIAI:Best Available Therapy | Plasma Concentrations for Ceftazidime and Avibactam - cIAI in PK Analysis Set | 23880.3 NG/ML |
| cIAI:CAZ-AVI + Metronidazole | Plasma Concentrations for Ceftazidime and Avibactam - cIAI in PK Analysis Set | 3061.3 NG/ML |
| cUTI:Best Available Therapy | Plasma Concentrations for Ceftazidime and Avibactam - cIAI in PK Analysis Set | 39465.3 NG/ML |
| cUTI:CAZ-AVI | Plasma Concentrations for Ceftazidime and Avibactam - cIAI in PK Analysis Set | 6304.1 NG/ML |
| CAZ (3) | Plasma Concentrations for Ceftazidime and Avibactam - cIAI in PK Analysis Set | 14904.8 NG/ML |
| AVI (3) | Plasma Concentrations for Ceftazidime and Avibactam - cIAI in PK Analysis Set | 1769.3 NG/ML |
Secondary
Plasma Concentrations for Ceftazidime and Avibactam - cUTI in PK Analysis Set
Blood samples were taken on Day 3 for ceftazidime and avibactam plasma concentration.
Time frame: Anytime within 15 minutes prior to or after stopping study drug, anytime between 30 to 90 minutes after stopping study drug, anytime between 300 to 360 minutes after stopping study drug
Population: PK Analysis set
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| cIAI:Best Available Therapy | Plasma Concentrations for Ceftazidime and Avibactam - cUTI in PK Analysis Set | 74260.2 NG/ML |
| cIAI:CAZ-AVI + Metronidazole | Plasma Concentrations for Ceftazidime and Avibactam - cUTI in PK Analysis Set | 10103.8 NG/ML |
| cUTI:Best Available Therapy | Plasma Concentrations for Ceftazidime and Avibactam - cUTI in PK Analysis Set | 56905.9 NG/ML |
| cUTI:CAZ-AVI | Plasma Concentrations for Ceftazidime and Avibactam - cUTI in PK Analysis Set | 8141.2 NG/ML |
| CAZ (3) | Plasma Concentrations for Ceftazidime and Avibactam - cUTI in PK Analysis Set | 21442.0 NG/ML |
| AVI (3) | Plasma Concentrations for Ceftazidime and Avibactam - cUTI in PK Analysis Set | 2425.0 NG/ML |
Secondary
The 28 Days All Cause Mortality Rate in EME at TOC Analysis Set
Proportion of patients with Day 28 all-cause mortality in EME at TOC analysis set. The death in the cIAI patient were reviewed independently by the SRP Chair.
Time frame: From first infusion to Day 28
Population: Extended microbiologically evaluable at TOC
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| cIAI:Best Available Therapy | The 28 Days All Cause Mortality Rate in EME at TOC Analysis Set | All cause mortality | 0 Participant |
| cIAI:Best Available Therapy | The 28 Days All Cause Mortality Rate in EME at TOC Analysis Set | Number of patients with any AE withoutcome=death | 0 Participant |
| cIAI:Best Available Therapy | The 28 Days All Cause Mortality Rate in EME at TOC Analysis Set | Deaths due to disease progression | 0 Participant |
| cIAI:CAZ-AVI + Metronidazole | The 28 Days All Cause Mortality Rate in EME at TOC Analysis Set | Deaths due to disease progression | 0 Participant |
| cIAI:CAZ-AVI + Metronidazole | The 28 Days All Cause Mortality Rate in EME at TOC Analysis Set | All cause mortality | 0 Participant |
| cIAI:CAZ-AVI + Metronidazole | The 28 Days All Cause Mortality Rate in EME at TOC Analysis Set | Number of patients with any AE withoutcome=death | 0 Participant |
| cUTI:Best Available Therapy | The 28 Days All Cause Mortality Rate in EME at TOC Analysis Set | Number of patients with any AE withoutcome=death | 1 Participant |
| cUTI:Best Available Therapy | The 28 Days All Cause Mortality Rate in EME at TOC Analysis Set | All cause mortality | 1 Participant |
| cUTI:Best Available Therapy | The 28 Days All Cause Mortality Rate in EME at TOC Analysis Set | Deaths due to disease progression | 0 Participant |
| cUTI:CAZ-AVI | The 28 Days All Cause Mortality Rate in EME at TOC Analysis Set | Number of patients with any AE withoutcome=death | 1 Participant |
| cUTI:CAZ-AVI | The 28 Days All Cause Mortality Rate in EME at TOC Analysis Set | Deaths due to disease progression | 0 Participant |
| cUTI:CAZ-AVI | The 28 Days All Cause Mortality Rate in EME at TOC Analysis Set | All cause mortality | 1 Participant |
Secondary
The 28 Days All Cause Mortality Rate in mMITT Analysis Set
Proportion of patients with Day 28 all-cause mortality in mMITT analysis set. The death in the cIAI patient were reviewed independently by the SRP Chair.
Time frame: From first infusion to Day 28
Population: Microbiological modified intent to treat
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| cIAI:Best Available Therapy | The 28 Days All Cause Mortality Rate in mMITT Analysis Set | All cause mortality | 1 Participant |
| cIAI:Best Available Therapy | The 28 Days All Cause Mortality Rate in mMITT Analysis Set | Number of patients with any AE with outcome=death | 1 Participant |
| cIAI:Best Available Therapy | The 28 Days All Cause Mortality Rate in mMITT Analysis Set | Deaths due to disease progression | 0 Participant |
| cIAI:CAZ-AVI + Metronidazole | The 28 Days All Cause Mortality Rate in mMITT Analysis Set | All cause mortality | 0 Participant |
| cIAI:CAZ-AVI + Metronidazole | The 28 Days All Cause Mortality Rate in mMITT Analysis Set | Number of patients with any AE with outcome=death | 0 Participant |
| cIAI:CAZ-AVI + Metronidazole | The 28 Days All Cause Mortality Rate in mMITT Analysis Set | Deaths due to disease progression | 0 Participant |
| cUTI:Best Available Therapy | The 28 Days All Cause Mortality Rate in mMITT Analysis Set | Deaths due to disease progression | 0 Participant |
| cUTI:Best Available Therapy | The 28 Days All Cause Mortality Rate in mMITT Analysis Set | All cause mortality | 3 Participant |
| cUTI:Best Available Therapy | The 28 Days All Cause Mortality Rate in mMITT Analysis Set | Number of patients with any AE with outcome=death | 3 Participant |
| cUTI:CAZ-AVI | The 28 Days All Cause Mortality Rate in mMITT Analysis Set | All cause mortality | 3 Participant |
| cUTI:CAZ-AVI | The 28 Days All Cause Mortality Rate in mMITT Analysis Set | Number of patients with any AE with outcome=death | 3 Participant |
| cUTI:CAZ-AVI | The 28 Days All Cause Mortality Rate in mMITT Analysis Set | Deaths due to disease progression | 0 Participant |
Secondary
The Reason for Treatment Change/Discontinuation in mMITT Analysis Set
Proportion of patients in the mMITT analysis set for whom the assigned study treatment was changed, discontinued, or interrupted. Creatinine clearance (CrCl)
Time frame: From first infusion to last infusion of study therapy. Duration of study therapy was 5 to 21 days.
Population: Microbiological modified intent to treat
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| cIAI:Best Available Therapy | The Reason for Treatment Change/Discontinuation in mMITT Analysis Set | Treatment Change | 1 Participant |
| cIAI:Best Available Therapy | The Reason for Treatment Change/Discontinuation in mMITT Analysis Set | Treatment Change - Crcl change | 1 Participant |
| cIAI:Best Available Therapy | The Reason for Treatment Change/Discontinuation in mMITT Analysis Set | Treatment Change - Other | 0 Participant |
| cIAI:Best Available Therapy | The Reason for Treatment Change/Discontinuation in mMITT Analysis Set | Treatment discontinuation | 4 Participant |
| cIAI:Best Available Therapy | The Reason for Treatment Change/Discontinuation in mMITT Analysis Set | Treatment discontinuation - AE | 1 Participant |
| cIAI:Best Available Therapy | The Reason for Treatment Change/Discontinuation in mMITT Analysis Set | Treatment discontinuation - Other | 3 Participant |
| cIAI:Best Available Therapy | The Reason for Treatment Change/Discontinuation in mMITT Analysis Set | Treatment interrupted | 0 Participant |
| cIAI:Best Available Therapy | The Reason for Treatment Change/Discontinuation in mMITT Analysis Set | Treatment interrupted - Change of infusion site | 0 Participant |
| cIAI:CAZ-AVI + Metronidazole | The Reason for Treatment Change/Discontinuation in mMITT Analysis Set | Treatment discontinuation - Other | 0 Participant |
| cIAI:CAZ-AVI + Metronidazole | The Reason for Treatment Change/Discontinuation in mMITT Analysis Set | Treatment discontinuation - AE | 0 Participant |
| cIAI:CAZ-AVI + Metronidazole | The Reason for Treatment Change/Discontinuation in mMITT Analysis Set | Treatment Change - Crcl change | 0 Participant |
| cIAI:CAZ-AVI + Metronidazole | The Reason for Treatment Change/Discontinuation in mMITT Analysis Set | Treatment interrupted - Change of infusion site | 0 Participant |
| cIAI:CAZ-AVI + Metronidazole | The Reason for Treatment Change/Discontinuation in mMITT Analysis Set | Treatment interrupted | 0 Participant |
| cIAI:CAZ-AVI + Metronidazole | The Reason for Treatment Change/Discontinuation in mMITT Analysis Set | Treatment discontinuation | 0 Participant |
| cIAI:CAZ-AVI + Metronidazole | The Reason for Treatment Change/Discontinuation in mMITT Analysis Set | Treatment Change - Other | 0 Participant |
| cIAI:CAZ-AVI + Metronidazole | The Reason for Treatment Change/Discontinuation in mMITT Analysis Set | Treatment Change | 0 Participant |
| cUTI:Best Available Therapy | The Reason for Treatment Change/Discontinuation in mMITT Analysis Set | Treatment interrupted | 0 Participant |
| cUTI:Best Available Therapy | The Reason for Treatment Change/Discontinuation in mMITT Analysis Set | Treatment Change - Other | 3 Participant |
| cUTI:Best Available Therapy | The Reason for Treatment Change/Discontinuation in mMITT Analysis Set | Treatment discontinuation | 3 Participant |
| cUTI:Best Available Therapy | The Reason for Treatment Change/Discontinuation in mMITT Analysis Set | Treatment discontinuation - AE | 1 Participant |
| cUTI:Best Available Therapy | The Reason for Treatment Change/Discontinuation in mMITT Analysis Set | Treatment discontinuation - Other | 2 Participant |
| cUTI:Best Available Therapy | The Reason for Treatment Change/Discontinuation in mMITT Analysis Set | Treatment interrupted - Change of infusion site | 0 Participant |
| cUTI:Best Available Therapy | The Reason for Treatment Change/Discontinuation in mMITT Analysis Set | Treatment Change - Crcl change | 5 Participant |
| cUTI:Best Available Therapy | The Reason for Treatment Change/Discontinuation in mMITT Analysis Set | Treatment Change | 8 Participant |
| cUTI:CAZ-AVI | The Reason for Treatment Change/Discontinuation in mMITT Analysis Set | Treatment Change - Crcl change | 10 Participant |
| cUTI:CAZ-AVI | The Reason for Treatment Change/Discontinuation in mMITT Analysis Set | Treatment discontinuation | 1 Participant |
| cUTI:CAZ-AVI | The Reason for Treatment Change/Discontinuation in mMITT Analysis Set | Treatment interrupted | 1 Participant |
| cUTI:CAZ-AVI | The Reason for Treatment Change/Discontinuation in mMITT Analysis Set | Treatment Change - Other | 1 Participant |
| cUTI:CAZ-AVI | The Reason for Treatment Change/Discontinuation in mMITT Analysis Set | Treatment discontinuation - AE | 1 Participant |
| cUTI:CAZ-AVI | The Reason for Treatment Change/Discontinuation in mMITT Analysis Set | Treatment interrupted - Change of infusion site | 1 Participant |
| cUTI:CAZ-AVI | The Reason for Treatment Change/Discontinuation in mMITT Analysis Set | Treatment Change | 11 Participant |
| cUTI:CAZ-AVI | The Reason for Treatment Change/Discontinuation in mMITT Analysis Set | Treatment discontinuation - Other | 0 Participant |