Nosocomial Pneumonia (NP), Ventilator-associated Pneumonia (VAP)
Conditions
Keywords
Ceftazidime,, Meropenem,, Anti-Bacterial Agents,, Anti-Infective Agents,, Therapeutic Uses,, Pharmacologic Actions,, Physiological Effects of Drugs
Brief summary
The purpose of the study is to evaluate the effects of Ceftazidime-Avibactam compared to Meropenem for treating hospitalized adults with nosocomial pneumonia including ventilator-associated pneumonia
Detailed description
A Phase III, Randomized, Multicentre, Double-blind, Double-dummy, Parallel-group Comparative Study to Determine the Efficacy, Safety And Tolerability of Ceftazidime-Avibactam Versus Meropenem in the Treatment of Nosocomial Pneumonia Including Ventilator-Associated Pneumonia in Hospitalized Adults
Interventions
DRUGceftazidim-avibactam (CAZ-AVI, experimental product)
2000mg ceftazidime plus 500mg avibactam
DRUGmeropenem (active comparator)
1000mg of Meropenem
Sponsors
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* 18 to 90 years of age inclusive * Females can participate if surgically sterile or completed menopause; if able to have children, must have negative serum pregnancy test, agree not to attempt pregnancy and use acceptable contraception while receiving study therapy and for 1 week after * Onset of symptoms ≥ 48 hours after admission or \<7 days after discharge from an inpatient acute or chronic care facility * New or worsening infiltrate on chest X-ray obtained within 48 hours prior to randomization * At least 1 of the following systemic signs:Fever (temperature \>38 C) or hypothermia (rectal/core temperature \<35 C); White blood cell count \>10,000 cells/mm3, or White blood cell count \<4500 cells/mm3, or \>15% band forms.
Exclusion criteria
* Pulmonary disease that, in the investigator's judgment, would preclude evaluation of therapeutic response (e.g. lung cancer, active tuberculosis, cystic fibrosis, granulomatous disease, fungal pulmonary infection or recent pulmonary embolism). * Patients with lung abscess, pleural empyema or post obstructive pneumonia. * Patients with an estimated creatinine clearance \<16ml/min by Cockcroft Gault formula or patients expected to require haemodialysis or other renal support while on study therapy. * Acute hepatitis in the prior 6 months, cirrhosis, acute hepatic failure or acute decompensation of chronic hepatic failure. * Patients receiving hemodialysis or peritoneal dialysis.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Number of Patients With Clinical Cure at Test-of-cure (TOC) Visit in the Clinically Modified Intent-to-treat Analysis Set (Co-primary Analyses) | At the test-of-cure (TOC) visit (Day 21 to 25) | The number of patients meeting the cure criteria: the patient was not a clinical failure at end of treatment and the patient is alive and all signs and symptoms of pneumonia have resolved or improved to an extent that no antibacterial therapy for Nosocomial Pneumonia was taken between end of treatment and test-of-cure inclusive. |
| The Number of Patients With Clinical Cure at Test-of-cure (TOC) Visit in the Clinically Evaluable at TOC Analysis Set (Co-primary Analyses) | At the test-of-cure (TOC) visit (Day 21 to 25) | The number of patients meeting the cure criteria: the patient was not a clinical failure at end of treatment and the patient is alive and all signs and symptoms of pneumonia have resolved or improved to an extent that no antibacterial therapy for Nosocomial Pneumonia was taken between end of treatment and test-of-cure inclusive. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The Number of Patients With Clinical Cure at Test-of-cure (TOC) Visit in the Microbiologically Evaluable Analysis Set | At the test-of-cure (TOC) visit (Day 21 to 25) | The number of patients meeting the cure criteria: the patient was not a clinical failure at end of treatment and the patient is alive and all signs and symptoms of pneumonia have resolved or improved to an extent that no antibacterial therapy for Nosocomial Pneumonia was taken between end of treatment and test-of-cure inclusive. |
| The Number of Patients With Clinical Cure at End of Treatment (EOT) Visit in Microbiologically Modified Intent-to-treat Analysis Set | Patients were followed after the last IV dose but no later than 24 hours after the last IV dose. | The number of patients meeting the cure criteria: the patient is alive and all signs and symptoms of pneumonia have resolved or improved such that all antibacterial therapies for Nosocomial Pneumonia are stopped. No antibacterial therapy other than those outlined by the protocol has been administered for Nosocomial Pneumonia prior to end of treatment. |
| The Number of Patients With Clinical Cure at End of Treatment (EOT) Visit in Clinically Modified Intent-to-treat Analysis Set | Patients were followed after the last IV dose but no later than 24 hours after the last IV dose. | The number of patients meeting the cure criteria: the patient is alive and all signs and symptoms of pneumonia have resolved or improved such that all antibacterial therapies for Nosocomial Pneumonia are stopped. No antibacterial therapy other than those outlined by the protocol has been administered for Nosocomial Pneumonia prior to end of treatment. |
| The Number of Patients With Clinical Cure at End of Treatment (EOT) Visit in Clinically Evaluable Analysis Set | Patients were followed after the last IV dose but no later than 24 hours after the last IV dose. | The number of patients meeting the cure criteria: the patient is alive and all signs and symptoms of pneumonia have resolved or improved such that all antibacterial therapies for Nosocomial Pneumonia are stopped. No antibacterial therapy other than those outlined by the protocol has been administered for Nosocomial Pneumonia prior to end of treatment. |
| The Number of Patients With Clinical Cure at End of Treatment (EOT) Visit in Extended Microbiologically Evaluable Analysis Set | Patients were followed after the last IV dose but no later than 24 hours after the last IV dose. | The number of patients meeting the cure criteria: the patient is alive and all signs and symptoms of pneumonia have resolved or improved such that all antibacterial therapies for Nosocomial Pneumonia are stopped. No antibacterial therapy other than those outlined by the protocol has been administered for Nosocomial Pneumonia prior to end of treatment. |
| The Number of Patients With Clinical Cure at End of Treatment (EOT) Visit in Microbiologically Evaluable Analysis Set | Patients were followed after the last IV dose but no later than 24 hours after the last IV dose. | The number of patients meeting the cure criteria: the patient is alive and all signs and symptoms of pneumonia have resolved or improved such that all antibacterial therapies for Nosocomial Pneumonia are stopped. No antibacterial therapy other than those outlined by the protocol has been administered for Nosocomial Pneumonia prior to end of treatment. |
| The Number of Patients With a Favorable Per-patient Microbiologic Response at End of Treatment (EOT) Visit in Microbiologically Modified Intent-to-treat Analysis Set | Patients were followed after the last IV dose but no later than 24 hours after the last IV dose. | Per-patient favorable response indicates that all of the patient's baseline pathogens are eradicated or presumed eradicated. Eradication is defined as: source specimen demonstrates absence of the original baseline pathogen. Presumed eradication is defined as: source specimen was not available to culture and the patient was assessed as a clinical cure. |
| The Number of Patients With a Favorable Per-patient Microbiologic Response at Test-of-cure (TOC) Visit in Microbiologically Modified Intent-to-treat Analysis Set | At the test-of-cure (TOC) visit (Day 21 to 25) | Per-patient favorable response indicates that all of the patient's baseline pathogens are eradicated or presumed eradicated. Eradication is defined as: source specimen demonstrates absence of the original baseline pathogen. Presumed eradication is defined as: source specimen was not available to culture and the patient was assessed as a clinical cure. |
| The Number of Patients With a Favorable Per-patient Microbiologic Response at End of Treatment (EOT) Visit in Extended Microbiologically Evaluable at End of Treatment Analysis Set | Patients were followed after the last IV dose but no later than 24 hours after the last IV dose. | Per-patient favorable response indicates that all of the patient's baseline pathogens are eradicated or presumed eradicated. Eradication is defined as: source specimen demonstrates absence of the original baseline pathogen. Presumed eradication is defined as: source specimen was not available to culture and the patient was assessed as a clinical cure. |
| The Number of Patients With a Favorable Per-patient Microbiologic Response at Test-of-cure (TOC) Visit in Extended Microbiologically Evaluable at Test-of-cure Analysis Set | At the test-of-cure (TOC) visit (Day 21 to 25) | Per-patient favorable response indicates that all of the patient's baseline pathogens are eradicated or presumed eradicated. Eradication is defined as: source specimen demonstrates absence of the original baseline pathogen. Presumed eradication is defined as: source specimen was not available to culture and the patient was assessed as a clinical cure. |
| The Number of Patients With a Favorable Per-patient Microbiologic Response at End of Treatment (EOT) Visit in Microbiologically Evaluable at End of Treatment Analysis Set | Patients were followed after the last IV dose but no later than 24 hours after the last IV dose. | Per-patient favorable response indicates that all of the patient's baseline pathogens are eradicated or presumed eradicated. Eradication is defined as: source specimen demonstrates absence of the original baseline pathogen. Presumed eradication is defined as: source specimen was not available to culture and the patient was assessed as a clinical cure. |
| The Number of Patients With a Favorable Per-patient Microbiologic Response at Test-of-cure (TOC) Visit in Microbiologically Evaluable at Test-of-cure Analysis Set | At the test-of-cure (TOC) visit (Day 21 to 25) | Per-patient favorable response indicates that all of the patient's baseline pathogens are eradicated or presumed eradicated. Eradication is defined as: source specimen demonstrates absence of the original baseline pathogen. Presumed eradication is defined as: source specimen was not available to culture and the patient was assessed as a clinical cure. |
| The Number of Favorable Per-pathogen Microbiologic Responses at End of Treatment (EOT) Visit in Microbiologically Modified Intent-to-treat Analysis Set at End of Treatment Visit | Patients were followed after the last IV dose but no later than 24 hours after the last IV dose. | The number of patients with a favorable per-pathogen microbiological response: favorable microbiological response includes: Eradication where, source specimen demonstrates absence of the original baseline pathogen. Presumed eradication where, source specimen was not available to culture and the patient was assessed as a clinical cure. |
| The Number of Favorable Per-pathogen Microbiologic Responses at End of Treatment (EOT) Visit in Extended Microbiologically Evaluable at End of Treatment Analysis Set | Patients were followed after the last IV dose but no later than 24 hours after the last IV dose. | The number of patients with a favorable per-pathogen microbiological response: favorable microbiological response includes: Eradication where, source specimen demonstrates absence of the original baseline pathogen. Presumed eradication where, source specimen was not available to culture and the patient was assessed as a clinical cure. |
| The Number of Favorable Per-pathogen Microbiologic Responses at End of Treatment (EOT) Visit in Microbiologically Evaluable at End of Treatment Analysis Set | Patients were followed after the last IV dose but no later than 24 hours after the last IV dose. | The number of patients with a favorable per-pathogen microbiological response: favorable microbiological response includes: Eradication where, source specimen demonstrates absence of the original baseline pathogen. Presumed eradication where, source specimen was not available to culture and the patient was assessed as a clinical cure. |
| The Number of Favorable Per-pathogen Microbiologic Responses at Test-of-cure (TOC) Visit in Microbiologically Modified Intent-to-treat Analysis Set at Test-of-cure Visit | At the test-of-cure (TOC) visit (Day 21 to 25) | The number of patients with a favorable per-pathogen microbiological response: favorable microbiological response includes: Eradication where, source specimen demonstrates absence of the original baseline pathogen. Presumed eradication where, source specimen was not available to culture and the patient was assessed as a clinical cure. |
| The Number of Favorable Per-pathogen Microbiologic Responses at Test-of-cure (TOC) Visit in Extended Microbiologically Evaluable at Test-of-cure Analysis Set | At the test-of-cure (TOC) visit (Day 21 to 25) | The number of patients with a favorable per-pathogen microbiological response: favorable microbiological response includes: Eradication where, source specimen demonstrates absence of the original baseline pathogen. Presumed eradication where, source specimen was not available to culture and the patient was assessed as a clinical cure. |
| The Number of Favorable Per-pathogen Microbiologic Responses at Test-of-cure (TOC) Visit in Microbiologically Evaluable at Test-of-cure Analysis Set | At the test-of-cure (TOC) visit (Day 21 to 25) | The number of patients with a favorable per-pathogen microbiological response: favorable microbiological response includes: Eradication where, source specimen demonstrates absence of the original baseline pathogen. Presumed eradication where, source specimen was not available to culture and the patient was assessed as a clinical cure. |
| The Number of Patients With Clinical Cure in Patients With Pathogens Resistant to Ceftazidime at End of Treatment (EOT) Visit in Clinically Modified Intent-to-treat Analysis Set at End of Treatment Visit | Patients were followed after the last IV dose but no later than 24 hours after the last IV dose. | The number of patients meeting the cure criteria: the patient is alive and all signs and symptoms of pneumonia have resolved or improved such that all antibacterial therapies for Nosocomial Pneumonia are stopped. No antibacterial therapy other than those outlined by the protocol has been administered for Nosocomial Pneumonia prior to end of treatment. |
| The Number of Patients With Clinical Cure in Patients With Pathogens Resistant to Ceftazidime at End of Treatment (EOT) Visit in Clinically Evaluable at End of Treatment Analysis Set | Patients were followed after the last IV dose but no later than 24 hours after the last IV dose. | The number of patients meeting the cure criteria: the patient is alive and all signs and symptoms of pneumonia have resolved or improved such that all antibacterial therapies for Nosocomial Pneumonia are stopped. No antibacterial therapy other than those outlined by the protocol has been administered for Nosocomial Pneumonia prior to end of treatment. |
| The Number of Patients With Clinical Cure in Patients With Pathogens Resistant to Ceftazidime at End of Treatment (EOT) Visit in Microbiologically Evaluable at End of Treatment Analysis Set | Patients were followed after the last IV dose but no later than 24 hours after the last IV dose. | The number of patients meeting the cure criteria: the patient is alive and all signs and symptoms of pneumonia have resolved or improved such that all antibacterial therapies for Nosocomial Pneumonia are stopped. No antibacterial therapy other than those outlined by the protocol has been administered for Nosocomial Pneumonia prior to end of treatment. |
| The Number of Patients With Clinical Cure in Patients With Pathogens Resistant to Ceftazidime at Test-of-cure (TOC) Visit in Clinically Modified Intent-to-treat Analysis Set at Test-of-cure Visit | At the test-of-cure (TOC) visit (Day 21 to 25) | The number of patients meeting the cure criteria: the patient was not a clinical failure at end of treatment and the patient is alive and all signs and symptoms of pneumonia have resolved or improved to an extent that no antibacterial therapy for Nosocomial Pneumonia was taken between end of treatment and test-of-cure inclusive. |
| The Number of Patients With Clinical Cure in Patients With Pathogens Resistant to Ceftazidime at Test-of-cure (TOC) Visit in Clinically Evaluable at Test-of-cure Analysis Set | At the test-of-cure (TOC) visit (Day 21 to 25) | The number of patients meeting the cure criteria: the patient was not a clinical failure at end of treatment and the patient is alive and all signs and symptoms of pneumonia have resolved or improved to an extent that no antibacterial therapy for Nosocomial Pneumonia was taken between end of treatment and test-of-cure inclusive. |
| The Number of Patients With Clinical Cure in Patients With Pathogens Resistant to Ceftazidime at Test-of-cure (TOC) Visit in Microbiologically Evaluable at Test-of-cure Analysis Set | At the test-of-cure (TOC) visit (Day 21 to 25) | The number of patients meeting the cure criteria: the patient was not a clinical failure at end of treatment and the patient is alive and all signs and symptoms of pneumonia have resolved or improved to an extent that no antibacterial therapy for Nosocomial Pneumonia was taken between end of treatment and test-of-cure inclusive. |
| Number of Patients With a Favorable Per-patient Microbiologic Response in Patients With Pathogens Resistant to Ceftazidime at End of Treatment (EOT) Visit in Microbiologically Modified Intent-to-treat Analysis Set at End of Treatment Visit | Patients were followed after the last IV dose but no later than 24 hours after the last IV dose. | Per-patient favorable response indicates that all of the patient's baseline pathogens are eradicated or presumed eradicated. Eradication is defined as: source specimen demonstrates absence of the original baseline pathogen. Presumed eradication is defined as: source specimen was not available to culture and the patient was assessed as a clinical cure. |
| Number of Patients With a Favorable Per-patient Microbiologic Response in Patients With Pathogens Resistant to Ceftazidime at End of Treatment (EOT) Visit in Extended Microbiologically Evaluable at End of Treatment Analysis Set | Patients were followed after the last IV dose but no later than 24 hours after the last IV dose. | Per-patient favorable response indicates that all of the patient's baseline pathogens are eradicated or presumed eradicated. Eradication is defined as: source specimen demonstrates absence of the original baseline pathogen. Presumed eradication is defined as: source specimen was not available to culture and the patient was assessed as a clinical cure. |
| Number of Patients With a Favorable Per-patient Microbiologic Response in Patients With Pathogens Resistant to Ceftazidime at End of Treatment (EOT) Visit in Microbiologically Evaluable at End of Treatment Analysis Set | Patients were followed after the last IV dose but no later than 24 hours after the last IV dose. | Per-patient favorable response indicates that all of the patient's baseline pathogens are eradicated or presumed eradicated. Eradication is defined as: source specimen demonstrates absence of the original baseline pathogen. Presumed eradication is defined as: source specimen was not available to culture and the patient was assessed as a clinical cure. |
| Number of Patients With a Favorable Per-patient Microbiologic Response in Patients With Pathogens Resistant to Ceftazidime at Test-of-cure (TOC) Visit in Microbiologically Modified Intent-to-treat Analysis Set at Test-of-cure Visit | At the test-of-cure (TOC) visit (Day 21 to 25) | Per-patient favorable response indicates that all of the patient's baseline pathogens are eradicated or presumed eradicated. Eradication is defined as: source specimen demonstrates absence of the original baseline pathogen. Presumed eradication is defined as: source specimen was not available to culture and the patient was assessed as a clinical cure. |
| Number of Patients With a Favorable Per-patient Microbiologic Response in Patients With Pathogens Resistant to Ceftazidime at Test-of-cure (TOC) Visit in Extended Microbiologically Evaluable at Test-of-cure Analysis Set | At the test-of-cure (TOC) visit (Day 21 to 25) | Per-patient favorable response indicates that all of the patient's baseline pathogens are eradicated or presumed eradicated. Eradication is defined as: source specimen demonstrates absence of the original baseline pathogen. Presumed eradication is defined as: source specimen was not available to culture and the patient was assessed as a clinical cure. |
| Number of Patients With a Favorable Per-patient Microbiologic Response in Patients With Pathogens Resistant to Ceftazidime at Test-of-cure (TOC) Visit in Microbiologically Evaluable at Test-of-cure Analysis Set | At the test-of-cure (TOC) visit (Day 21 to 25) | Per-patient favorable response indicates that all of the patient's baseline pathogens are eradicated or presumed eradicated. Eradication is defined as: source specimen demonstrates absence of the original baseline pathogen. Presumed eradication is defined as: source specimen was not available to culture and the patient was assessed as a clinical cure. |
| The Number of Favorable Per-pathogen Microbiologic Responses in Patients With Pathogens Resistant to Ceftazidime at End of Treatment (EOT) Visit in Microbiologically Modified Intent-to-treat Analysis Set at End of Treatment Visit | Patients were followed after the last IV dose but no later than 24 hours after the last IV dose. | The number of patients with a favorable per-pathogen microbiological response: favorable microbiological response includes: Eradication where, source specimen demonstrates absence of the original baseline pathogen. Presumed eradication where, source specimen was not available to culture and the patient was assessed as a clinical cure. |
| The Number of Favorable Per-pathogen Microbiologic Responses in Patients With Pathogens Resistant to Ceftazidime at End of Treatment (EOT) Visit in Extended Microbiologically Evaluable at End of Treatment Analysis Set | Patients were followed after the last IV dose but no later than 24 hours after the last IV dose. | The number of patients with a favorable per-pathogen microbiological response: favorable microbiological response includes: Eradication where, source specimen demonstrates absence of the original baseline pathogen. Presumed eradication where, source specimen was not available to culture and the patient was assessed as a clinical cure. |
| The Number of Favorable Per-pathogen Microbiologic Responses in Patients With Pathogens Resistant to Ceftazidime at End of Treatment (EOT) Visit in Microbiologically Evaluable at End of Treatment Analysis Set | Patients were followed after the last IV dose but no later than 24 hours after the last IV dose. | The number of patients with a favorable per-pathogen microbiological response: favorable microbiological response includes: Eradication where, source specimen demonstrates absence of the original baseline pathogen. Presumed eradication where, source specimen was not available to culture and the patient was assessed as a clinical cure. |
| The Number of Favorable Per-pathogen Microbiologic Responses in Patients With Pathogens Resistant to Ceftazidime at Test-of-cure (TOC) Visit in Microbiologically Modified Intent-to-treat Analysis Set at Test-of-cure Visit | At the test-of-cure (TOC) visit (Day 21 to 25) | The number of patients with a favorable per-pathogen microbiological response: favorable microbiological response includes: Eradication where, source specimen demonstrates absence of the original baseline pathogen. Presumed eradication where, source specimen was not available to culture and the patient was assessed as a clinical cure. |
| The Number of Favorable Per-pathogen Microbiologic Responses in Patients With Pathogens Resistant to Ceftazidime at Test-of-cure (TOC) Visit in Extended Microbiologically Evaluable at Test-of-cure Analysis Set | At the test-of-cure (TOC) visit (Day 21 to 25) | The number of patients with a favorable per-pathogen microbiological response: favorable microbiological response includes: Eradication where, source specimen demonstrates absence of the original baseline pathogen. Presumed eradication where, source specimen was not available to culture and the patient was assessed as a clinical cure. |
| The Number of Favorable Per-pathogen Microbiologic Responses in Patients With Pathogens Resistant to Ceftazidime at Test-of-cure (TOC) Visit in Microbiologically Evaluable at Test-of-cure Analysis Set | At the test-of-cure (TOC) visit (Day 21 to 25) | The number of patients with a favorable per-pathogen microbiological response: favorable microbiological response includes: Eradication where, source specimen demonstrates absence of the original baseline pathogen. Presumed eradication where, source specimen was not available to culture and the patient was assessed as a clinical cure. |
| The Number of Patients With Death Due to Any Cause (All-cause Mortality) at Test-of-cure (TOC) Visit in Microbiologically Modified Intent-to-treat Analysis Set at Test-of-cure Visit | At the test-of-cure (TOC) visit (Day 21 to 25) | The number of patients with death due to any cause (all-cause mortality) in microbiologically modified intent-to-treat analysis set at test-of-cure visit. |
| The Number of Patients With Death Due to Any Cause (All-cause Mortality) at Test-of-cure (TOC) Visit in Clinically Modified Intent-to-treat Analysis Set at Test-of-cure Visit | At the test-of-cure (TOC) visit (Day 21 to 25) | The number of patients with death due to any cause (all-cause mortality) in clinically modified intent-to-treat analysis set at test-of-cure visit. |
| The Number of Patients With Death Due to Any Cause (All-cause Mortality) at Test-of-cure (TOC) Visit in the Clinically Evaluable at Test-of-cure Analysis Set | At the test-of-cure (TOC) visit (Day 21 to 25) | The number of patients with death due to any cause (all-cause mortality) in the clinically evaluable at test-of-cure analysis set. |
| The Number of Patients With Death Due to Any Cause (All-cause Mortality) in Microbiologically Modified Intent-to-treat Analysis Set at Day 28 | at Day 28 from randomization | The number of patients with death due to any cause (all-cause mortality) in microbiologically modified intent-to-treat analysis set at day 28. |
| The Number of Patients With Clinical Cure at Test-of-cure (TOC) Visit in the Microbiologically Modified Intent-to-treat Analysis Set | At the test-of-cure (TOC) visit (Day 21 to 25) | The number of patients meeting the cure criteria: the patient was not a clinical failure at end of treatment and the patient is alive and all signs and symptoms of pneumonia have resolved or improved to an extent that no antibacterial therapy for Nosocomial Pneumonia was taken between end of treatment and test-of-cure inclusive. |
| The Number of Patients With Death Due to Any Cause (All-cause Mortality) in the Clinically Evaluable at Test-of-cure Analysis Set at Day 28 | at Day 28 from randomization | The number of patients with death due to any cause (all-cause mortality) in the clinically evaluable at test-of-cure analysis set at day 28. |
| The Number of Patients Discharged From Hospital up to Test-of-cure (TOC) Visit in Microbiologically Modified Intent-to-treat Analysis Set | up to 25 days from randomization | The number of patients discharged from hospital in microbiologically modified intent-to-treat analysis set. |
| The Number of Patients Discharged From Hospital up to Test-of-cure (TOC) Visit in the Clinically Modified Intent-to-treat Analysis Set | up to 25 days from randomization | The number of patients discharged from hospital in the clinically modified intent-to-treat analysis set. |
| The Number of Patients Discharged From Hospital up to Test-of-cure (TOC) Visit in the Clinically Evaluable at Test-of-cure Analysis Set | up to 25 days from randomization | The number of patients discharged from hospital in the clinically evaluable at test-of-cure analysis set. |
| The Number of Patients With Death Due to Any Cause (All-cause Mortality) in Clinically Modified Intent-to-treat Analysis Set at Day 28 | at Day 28 from randomization | The number of patients with death due to any cause (all-cause mortality) in clinically modified intent-to-treat analysis set at day 28. |
| The Number of Patients With Clinical Cure at Test-of-cure (TOC) Visit in the Extended Microbiologically Evaluable Analysis Set | At the test-of-cure (TOC) visit (Day 21 to 25) | The number of patients meeting the cure criteria: the patient was not a clinical failure at end of treatment and the patient is alive and all signs and symptoms of pneumonia have resolved or improved to an extent that no antibacterial therapy for Nosocomial Pneumonia was taken between end of treatment and test-of-cure inclusive. |
Countries
Argentina, Brazil, Bulgaria, China, Czechia, France, Hungary, India, Italy, Japan, Latvia, Mexico, Peru, Philippines, Poland, Romania, Russia, Slovenia, South Africa, South Korea, Spain, Taiwan, Turkey (Türkiye), Ukraine, United Kingdom, Vietnam
Participant flow
Recruitment details
Overall, 879 patients were randomized in this study, from 4 geographic regions. The first patient was enrolled on 13 April 2013 and the last patient last visit was on 07 January 2016. Summary tables exclude 62 patients with moderate/severe renal impairment recruited prior to a protocol amendment to the dose regimen for such patients (MSRIBorig).
Pre-assignment details
The first patient was enrolled on 13 April 2013 and the last patient last vist was on 07 January 2016. Overall, 969 patients were enrolled in this study, 90 of them screen failures.
Participants by arm
| Arm | Count |
|---|---|
| CAZ-AVI 2000mg ceftazidime / 500mg avibactam intravenous (IV) infused over 2 hours plus appropriate placebo to meropenem | 405 |
| Meropenem meropenem 1000mg IV infused over 30 minutes plus CAZ-AVI placebo | 403 |
| Total | 808 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 39 | 29 |
| Overall Study | Lost to Follow-up | 3 | 7 |
| Overall Study | Other Eligibility criteria | 3 | 5 |
| Overall Study | Withdrawal by Subject | 9 | 4 |
Baseline characteristics
| Characteristic | CAZ-AVI | Meropenem | Total |
|---|---|---|---|
| Age, Continuous | 61.8 Years STANDARD_DEVIATION 16.76 | 61.7 Years STANDARD_DEVIATION 17.57 | 61.7 Years STANDARD_DEVIATION 17.16 |
| Age, Customized 18-45 | 74 Participants | 74 Participants | 148 Participants |
| Age, Customized 46-64 | 124 Participants | 122 Participants | 246 Participants |
| Age, Customized 65-74 | 97 Participants | 95 Participants | 192 Participants |
| Age, Customized 75-90 | 110 Participants | 112 Participants | 222 Participants |
| Race/Ethnicity, Customized Asian | 226 Participants | 217 Participants | 443 Participants |
| Race/Ethnicity, Customized Black/African American | 3 Participants | 2 Participants | 5 Participants |
| Race/Ethnicity, Customized Native Hawaiian/Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Other | 5 Participants | 7 Participants | 12 Participants |
| Race/Ethnicity, Customized White | 171 Participants | 177 Participants | 348 Participants |
| Sex: Female, Male Female | 101 Participants | 105 Participants | 206 Participants |
| Sex: Female, Male Male | 304 Participants | 298 Participants | 602 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 198 / 405 | 195 / 403 |
| serious Total, serious adverse events | 75 / 405 | 54 / 403 |
Outcome results
Primary
The Number of Patients With Clinical Cure at Test-of-cure (TOC) Visit in the Clinically Evaluable at TOC Analysis Set (Co-primary Analyses)
The number of patients meeting the cure criteria: the patient was not a clinical failure at end of treatment and the patient is alive and all signs and symptoms of pneumonia have resolved or improved to an extent that no antibacterial therapy for Nosocomial Pneumonia was taken between end of treatment and test-of-cure inclusive.
Time frame: At the test-of-cure (TOC) visit (Day 21 to 25)
Population: The clinically evaluable (CE) analysis set included all patients in the clinical modified intent-to-treat (cMITT) analysis set who met the stringent criteria for clinical evaluation described in the protocol regarding dosing, prior and concomitant medication, evaluation, etc.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CAZ-AVI | The Number of Patients With Clinical Cure at Test-of-cure (TOC) Visit in the Clinically Evaluable at TOC Analysis Set (Co-primary Analyses) | Clinical cure | 199 participants |
| CAZ-AVI | The Number of Patients With Clinical Cure at Test-of-cure (TOC) Visit in the Clinically Evaluable at TOC Analysis Set (Co-primary Analyses) | Clinical failure | 58 participants |
| Meropenem | The Number of Patients With Clinical Cure at Test-of-cure (TOC) Visit in the Clinically Evaluable at TOC Analysis Set (Co-primary Analyses) | Clinical cure | 211 participants |
| Meropenem | The Number of Patients With Clinical Cure at Test-of-cure (TOC) Visit in the Clinically Evaluable at TOC Analysis Set (Co-primary Analyses) | Clinical failure | 59 participants |
Comparison: Statistical analysis for the proportion of patients with clinical cure at TOC in CE at TOC analysis setp-value: <0.00195% CI: [-7.86, 6.39]% Risk Difference (RD)
Primary
The Number of Patients With Clinical Cure at Test-of-cure (TOC) Visit in the Clinically Modified Intent-to-treat Analysis Set (Co-primary Analyses)
The number of patients meeting the cure criteria: the patient was not a clinical failure at end of treatment and the patient is alive and all signs and symptoms of pneumonia have resolved or improved to an extent that no antibacterial therapy for Nosocomial Pneumonia was taken between end of treatment and test-of-cure inclusive.
Time frame: At the test-of-cure (TOC) visit (Day 21 to 25)
Population: The clinical modified intent-to-treat (cMITT) included all patients who met the minimum disease criteria and received any amount of study treatment, and had either no baseline pathogens or at least one study-qualifying Gram-negative baseline pathogen.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CAZ-AVI | The Number of Patients With Clinical Cure at Test-of-cure (TOC) Visit in the Clinically Modified Intent-to-treat Analysis Set (Co-primary Analyses) | Clinical cure | 245 participants |
| CAZ-AVI | The Number of Patients With Clinical Cure at Test-of-cure (TOC) Visit in the Clinically Modified Intent-to-treat Analysis Set (Co-primary Analyses) | Clinical failure | 79 participants |
| CAZ-AVI | The Number of Patients With Clinical Cure at Test-of-cure (TOC) Visit in the Clinically Modified Intent-to-treat Analysis Set (Co-primary Analyses) | Indeterminate | 32 participants |
| Meropenem | The Number of Patients With Clinical Cure at Test-of-cure (TOC) Visit in the Clinically Modified Intent-to-treat Analysis Set (Co-primary Analyses) | Clinical cure | 270 participants |
| Meropenem | The Number of Patients With Clinical Cure at Test-of-cure (TOC) Visit in the Clinically Modified Intent-to-treat Analysis Set (Co-primary Analyses) | Clinical failure | 70 participants |
| Meropenem | The Number of Patients With Clinical Cure at Test-of-cure (TOC) Visit in the Clinically Modified Intent-to-treat Analysis Set (Co-primary Analyses) | Indeterminate | 30 participants |
Comparison: Statistical analysis for the proportion of patients with clinical cure at TOC in cMITT analysis setp-value: 0.00795% CI: [-10.76, 2.46]% Risk Difference (RD)
Secondary
Number of Patients With a Favorable Per-patient Microbiologic Response in Patients With Pathogens Resistant to Ceftazidime at End of Treatment (EOT) Visit in Extended Microbiologically Evaluable at End of Treatment Analysis Set
Per-patient favorable response indicates that all of the patient's baseline pathogens are eradicated or presumed eradicated. Eradication is defined as: source specimen demonstrates absence of the original baseline pathogen. Presumed eradication is defined as: source specimen was not available to culture and the patient was assessed as a clinical cure.
Time frame: Patients were followed after the last IV dose but no later than 24 hours after the last IV dose.
Population: The extended-ME (EME) analysis set defined as all patients in clinically evaluable (CE) analysis set with at least 1 etiologic pathogen from an adequate baseline culture regardless of susceptibility to study agents. Patients infected with ceftazidime-resistant Gram negative pathogens at EOT
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CAZ-AVI | Number of Patients With a Favorable Per-patient Microbiologic Response in Patients With Pathogens Resistant to Ceftazidime at End of Treatment (EOT) Visit in Extended Microbiologically Evaluable at End of Treatment Analysis Set | Favorable | 31 participants |
| CAZ-AVI | Number of Patients With a Favorable Per-patient Microbiologic Response in Patients With Pathogens Resistant to Ceftazidime at End of Treatment (EOT) Visit in Extended Microbiologically Evaluable at End of Treatment Analysis Set | Unfavorable | 9 participants |
| Meropenem | Number of Patients With a Favorable Per-patient Microbiologic Response in Patients With Pathogens Resistant to Ceftazidime at End of Treatment (EOT) Visit in Extended Microbiologically Evaluable at End of Treatment Analysis Set | Favorable | 36 participants |
| Meropenem | Number of Patients With a Favorable Per-patient Microbiologic Response in Patients With Pathogens Resistant to Ceftazidime at End of Treatment (EOT) Visit in Extended Microbiologically Evaluable at End of Treatment Analysis Set | Unfavorable | 13 participants |
Secondary
Number of Patients With a Favorable Per-patient Microbiologic Response in Patients With Pathogens Resistant to Ceftazidime at End of Treatment (EOT) Visit in Microbiologically Evaluable at End of Treatment Analysis Set
Per-patient favorable response indicates that all of the patient's baseline pathogens are eradicated or presumed eradicated. Eradication is defined as: source specimen demonstrates absence of the original baseline pathogen. Presumed eradication is defined as: source specimen was not available to culture and the patient was assessed as a clinical cure.
Time frame: Patients were followed after the last IV dose but no later than 24 hours after the last IV dose.
Population: The microbiologically evaluable (ME) analysis sets defined as all patients in clinically evaluable (CE) analysis set with at least 1 etiologic pathogen from an adequate baseline culture that is susceptible to both study agents (CAZ-AVI and meropenem). Patients infected with ceftazidime-resistant Gram negative pathogens at EOT
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CAZ-AVI | Number of Patients With a Favorable Per-patient Microbiologic Response in Patients With Pathogens Resistant to Ceftazidime at End of Treatment (EOT) Visit in Microbiologically Evaluable at End of Treatment Analysis Set | Unfavorable | 7 participants |
| CAZ-AVI | Number of Patients With a Favorable Per-patient Microbiologic Response in Patients With Pathogens Resistant to Ceftazidime at End of Treatment (EOT) Visit in Microbiologically Evaluable at End of Treatment Analysis Set | Favorable | 26 participants |
| Meropenem | Number of Patients With a Favorable Per-patient Microbiologic Response in Patients With Pathogens Resistant to Ceftazidime at End of Treatment (EOT) Visit in Microbiologically Evaluable at End of Treatment Analysis Set | Unfavorable | 11 participants |
| Meropenem | Number of Patients With a Favorable Per-patient Microbiologic Response in Patients With Pathogens Resistant to Ceftazidime at End of Treatment (EOT) Visit in Microbiologically Evaluable at End of Treatment Analysis Set | Favorable | 29 participants |
Secondary
Number of Patients With a Favorable Per-patient Microbiologic Response in Patients With Pathogens Resistant to Ceftazidime at End of Treatment (EOT) Visit in Microbiologically Modified Intent-to-treat Analysis Set at End of Treatment Visit
Per-patient favorable response indicates that all of the patient's baseline pathogens are eradicated or presumed eradicated. Eradication is defined as: source specimen demonstrates absence of the original baseline pathogen. Presumed eradication is defined as: source specimen was not available to culture and the patient was assessed as a clinical cure.
Time frame: Patients were followed after the last IV dose but no later than 24 hours after the last IV dose.
Population: The microbiological modified intent-to-treat (mMITT) analysis set included all patients who met the minimum disease criteria and received any amount of study treatment, and had at least one study-qualifying Gram-negative baseline pathogen. Patients infected with ceftazidime-resistant Gram negative pathogens at EOT
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CAZ-AVI | Number of Patients With a Favorable Per-patient Microbiologic Response in Patients With Pathogens Resistant to Ceftazidime at End of Treatment (EOT) Visit in Microbiologically Modified Intent-to-treat Analysis Set at End of Treatment Visit | Favorable | 35 participants |
| CAZ-AVI | Number of Patients With a Favorable Per-patient Microbiologic Response in Patients With Pathogens Resistant to Ceftazidime at End of Treatment (EOT) Visit in Microbiologically Modified Intent-to-treat Analysis Set at End of Treatment Visit | Indeterminate | 1 participants |
| CAZ-AVI | Number of Patients With a Favorable Per-patient Microbiologic Response in Patients With Pathogens Resistant to Ceftazidime at End of Treatment (EOT) Visit in Microbiologically Modified Intent-to-treat Analysis Set at End of Treatment Visit | Unfavorable | 10 participants |
| Meropenem | Number of Patients With a Favorable Per-patient Microbiologic Response in Patients With Pathogens Resistant to Ceftazidime at End of Treatment (EOT) Visit in Microbiologically Modified Intent-to-treat Analysis Set at End of Treatment Visit | Favorable | 39 participants |
| Meropenem | Number of Patients With a Favorable Per-patient Microbiologic Response in Patients With Pathogens Resistant to Ceftazidime at End of Treatment (EOT) Visit in Microbiologically Modified Intent-to-treat Analysis Set at End of Treatment Visit | Unfavorable | 13 participants |
| Meropenem | Number of Patients With a Favorable Per-patient Microbiologic Response in Patients With Pathogens Resistant to Ceftazidime at End of Treatment (EOT) Visit in Microbiologically Modified Intent-to-treat Analysis Set at End of Treatment Visit | Indeterminate | 2 participants |
Secondary
Number of Patients With a Favorable Per-patient Microbiologic Response in Patients With Pathogens Resistant to Ceftazidime at Test-of-cure (TOC) Visit in Extended Microbiologically Evaluable at Test-of-cure Analysis Set
Per-patient favorable response indicates that all of the patient's baseline pathogens are eradicated or presumed eradicated. Eradication is defined as: source specimen demonstrates absence of the original baseline pathogen. Presumed eradication is defined as: source specimen was not available to culture and the patient was assessed as a clinical cure.
Time frame: At the test-of-cure (TOC) visit (Day 21 to 25)
Population: The extended-ME (EME) analysis set defined as all patients in clinically evaluable (CE) analysis set with at least 1 etiologic pathogen from an adequate baseline culture regardless of susceptibility to study agents. Patients infected with ceftazidime-resistant Gram negative pathogens at TOC
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CAZ-AVI | Number of Patients With a Favorable Per-patient Microbiologic Response in Patients With Pathogens Resistant to Ceftazidime at Test-of-cure (TOC) Visit in Extended Microbiologically Evaluable at Test-of-cure Analysis Set | Favorable | 23 participants |
| CAZ-AVI | Number of Patients With a Favorable Per-patient Microbiologic Response in Patients With Pathogens Resistant to Ceftazidime at Test-of-cure (TOC) Visit in Extended Microbiologically Evaluable at Test-of-cure Analysis Set | Unfavorable | 14 participants |
| Meropenem | Number of Patients With a Favorable Per-patient Microbiologic Response in Patients With Pathogens Resistant to Ceftazidime at Test-of-cure (TOC) Visit in Extended Microbiologically Evaluable at Test-of-cure Analysis Set | Favorable | 21 participants |
| Meropenem | Number of Patients With a Favorable Per-patient Microbiologic Response in Patients With Pathogens Resistant to Ceftazidime at Test-of-cure (TOC) Visit in Extended Microbiologically Evaluable at Test-of-cure Analysis Set | Unfavorable | 20 participants |
Secondary
Number of Patients With a Favorable Per-patient Microbiologic Response in Patients With Pathogens Resistant to Ceftazidime at Test-of-cure (TOC) Visit in Microbiologically Evaluable at Test-of-cure Analysis Set
Per-patient favorable response indicates that all of the patient's baseline pathogens are eradicated or presumed eradicated. Eradication is defined as: source specimen demonstrates absence of the original baseline pathogen. Presumed eradication is defined as: source specimen was not available to culture and the patient was assessed as a clinical cure.
Time frame: At the test-of-cure (TOC) visit (Day 21 to 25)
Population: The microbiologically evaluable (ME) analysis sets defined as all patients in clinically evaluable (CE) analysis set with at least 1 etiologic pathogen from an adequate baseline culture that is susceptible to both study agents (CAZ-AVI and meropenem). Patients infected with ceftazidime-resistant Gram negative pathogens at TOC
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CAZ-AVI | Number of Patients With a Favorable Per-patient Microbiologic Response in Patients With Pathogens Resistant to Ceftazidime at Test-of-cure (TOC) Visit in Microbiologically Evaluable at Test-of-cure Analysis Set | Favorable | 21 participants |
| CAZ-AVI | Number of Patients With a Favorable Per-patient Microbiologic Response in Patients With Pathogens Resistant to Ceftazidime at Test-of-cure (TOC) Visit in Microbiologically Evaluable at Test-of-cure Analysis Set | Unfavorable | 9 participants |
| Meropenem | Number of Patients With a Favorable Per-patient Microbiologic Response in Patients With Pathogens Resistant to Ceftazidime at Test-of-cure (TOC) Visit in Microbiologically Evaluable at Test-of-cure Analysis Set | Unfavorable | 14 participants |
| Meropenem | Number of Patients With a Favorable Per-patient Microbiologic Response in Patients With Pathogens Resistant to Ceftazidime at Test-of-cure (TOC) Visit in Microbiologically Evaluable at Test-of-cure Analysis Set | Favorable | 18 participants |
Secondary
Number of Patients With a Favorable Per-patient Microbiologic Response in Patients With Pathogens Resistant to Ceftazidime at Test-of-cure (TOC) Visit in Microbiologically Modified Intent-to-treat Analysis Set at Test-of-cure Visit
Per-patient favorable response indicates that all of the patient's baseline pathogens are eradicated or presumed eradicated. Eradication is defined as: source specimen demonstrates absence of the original baseline pathogen. Presumed eradication is defined as: source specimen was not available to culture and the patient was assessed as a clinical cure.
Time frame: At the test-of-cure (TOC) visit (Day 21 to 25)
Population: The microbiological modified intent-to-treat (mMITT) analysis set included all patients who met the minimum disease criteria and received any amount of study treatment, and had at least one study-qualifying Gram-negative baseline pathogen. Patients infected with ceftazidime-resistant Gram negative pathogens at TOC
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CAZ-AVI | Number of Patients With a Favorable Per-patient Microbiologic Response in Patients With Pathogens Resistant to Ceftazidime at Test-of-cure (TOC) Visit in Microbiologically Modified Intent-to-treat Analysis Set at Test-of-cure Visit | Favorable | 27 participants |
| CAZ-AVI | Number of Patients With a Favorable Per-patient Microbiologic Response in Patients With Pathogens Resistant to Ceftazidime at Test-of-cure (TOC) Visit in Microbiologically Modified Intent-to-treat Analysis Set at Test-of-cure Visit | Unfavorable | 16 participants |
| CAZ-AVI | Number of Patients With a Favorable Per-patient Microbiologic Response in Patients With Pathogens Resistant to Ceftazidime at Test-of-cure (TOC) Visit in Microbiologically Modified Intent-to-treat Analysis Set at Test-of-cure Visit | Indeterminate | 3 participants |
| Meropenem | Number of Patients With a Favorable Per-patient Microbiologic Response in Patients With Pathogens Resistant to Ceftazidime at Test-of-cure (TOC) Visit in Microbiologically Modified Intent-to-treat Analysis Set at Test-of-cure Visit | Indeterminate | 4 participants |
| Meropenem | Number of Patients With a Favorable Per-patient Microbiologic Response in Patients With Pathogens Resistant to Ceftazidime at Test-of-cure (TOC) Visit in Microbiologically Modified Intent-to-treat Analysis Set at Test-of-cure Visit | Favorable | 27 participants |
| Meropenem | Number of Patients With a Favorable Per-patient Microbiologic Response in Patients With Pathogens Resistant to Ceftazidime at Test-of-cure (TOC) Visit in Microbiologically Modified Intent-to-treat Analysis Set at Test-of-cure Visit | Unfavorable | 23 participants |
Secondary
The Number of Favorable Per-pathogen Microbiologic Responses at End of Treatment (EOT) Visit in Extended Microbiologically Evaluable at End of Treatment Analysis Set
The number of patients with a favorable per-pathogen microbiological response: favorable microbiological response includes: Eradication where, source specimen demonstrates absence of the original baseline pathogen. Presumed eradication where, source specimen was not available to culture and the patient was assessed as a clinical cure.
Time frame: Patients were followed after the last IV dose but no later than 24 hours after the last IV dose.
Population: The extended-ME (EME) analysis set defined as all patients in clinically evaluable (CE) analysis set with at least 1 etiologic pathogen from an adequate baseline culture regardless of susceptibility to study agents. (pathogens in ≥10 patients)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CAZ-AVI | The Number of Favorable Per-pathogen Microbiologic Responses at End of Treatment (EOT) Visit in Extended Microbiologically Evaluable at End of Treatment Analysis Set | Enterobacter cloacae (n=22, 17) | 22 participants with favorable responses |
| CAZ-AVI | The Number of Favorable Per-pathogen Microbiologic Responses at End of Treatment (EOT) Visit in Extended Microbiologically Evaluable at End of Treatment Analysis Set | Pseudomonas aeruginosa (n=50, 41) | 30 participants with favorable responses |
| CAZ-AVI | The Number of Favorable Per-pathogen Microbiologic Responses at End of Treatment (EOT) Visit in Extended Microbiologically Evaluable at End of Treatment Analysis Set | Serratia marcescens (n=13, 10) | 12 participants with favorable responses |
| CAZ-AVI | The Number of Favorable Per-pathogen Microbiologic Responses at End of Treatment (EOT) Visit in Extended Microbiologically Evaluable at End of Treatment Analysis Set | Escherichia coli (n=14, 18) | 13 participants with favorable responses |
| CAZ-AVI | The Number of Favorable Per-pathogen Microbiologic Responses at End of Treatment (EOT) Visit in Extended Microbiologically Evaluable at End of Treatment Analysis Set | Proteus mirabilis (n=9, 8) | 8 participants with favorable responses |
| CAZ-AVI | The Number of Favorable Per-pathogen Microbiologic Responses at End of Treatment (EOT) Visit in Extended Microbiologically Evaluable at End of Treatment Analysis Set | Klebsiella pneumoniae (n=46, 57) | 39 participants with favorable responses |
| CAZ-AVI | The Number of Favorable Per-pathogen Microbiologic Responses at End of Treatment (EOT) Visit in Extended Microbiologically Evaluable at End of Treatment Analysis Set | Haemophilus influenzae (n=14, 16) | 14 participants with favorable responses |
| CAZ-AVI | The Number of Favorable Per-pathogen Microbiologic Responses at End of Treatment (EOT) Visit in Extended Microbiologically Evaluable at End of Treatment Analysis Set | Staphylococcus aureus (n=18, 26) | 16 participants with favorable responses |
| CAZ-AVI | The Number of Favorable Per-pathogen Microbiologic Responses at End of Treatment (EOT) Visit in Extended Microbiologically Evaluable at End of Treatment Analysis Set | Enterobacter aerogenes (n=6, 7) | 4 participants with favorable responses |
| Meropenem | The Number of Favorable Per-pathogen Microbiologic Responses at End of Treatment (EOT) Visit in Extended Microbiologically Evaluable at End of Treatment Analysis Set | Staphylococcus aureus (n=18, 26) | 25 participants with favorable responses |
| Meropenem | The Number of Favorable Per-pathogen Microbiologic Responses at End of Treatment (EOT) Visit in Extended Microbiologically Evaluable at End of Treatment Analysis Set | Enterobacter aerogenes (n=6, 7) | 5 participants with favorable responses |
| Meropenem | The Number of Favorable Per-pathogen Microbiologic Responses at End of Treatment (EOT) Visit in Extended Microbiologically Evaluable at End of Treatment Analysis Set | Klebsiella pneumoniae (n=46, 57) | 53 participants with favorable responses |
| Meropenem | The Number of Favorable Per-pathogen Microbiologic Responses at End of Treatment (EOT) Visit in Extended Microbiologically Evaluable at End of Treatment Analysis Set | Proteus mirabilis (n=9, 8) | 6 participants with favorable responses |
| Meropenem | The Number of Favorable Per-pathogen Microbiologic Responses at End of Treatment (EOT) Visit in Extended Microbiologically Evaluable at End of Treatment Analysis Set | Serratia marcescens (n=13, 10) | 8 participants with favorable responses |
| Meropenem | The Number of Favorable Per-pathogen Microbiologic Responses at End of Treatment (EOT) Visit in Extended Microbiologically Evaluable at End of Treatment Analysis Set | Haemophilus influenzae (n=14, 16) | 16 participants with favorable responses |
| Meropenem | The Number of Favorable Per-pathogen Microbiologic Responses at End of Treatment (EOT) Visit in Extended Microbiologically Evaluable at End of Treatment Analysis Set | Enterobacter cloacae (n=22, 17) | 17 participants with favorable responses |
| Meropenem | The Number of Favorable Per-pathogen Microbiologic Responses at End of Treatment (EOT) Visit in Extended Microbiologically Evaluable at End of Treatment Analysis Set | Escherichia coli (n=14, 18) | 17 participants with favorable responses |
| Meropenem | The Number of Favorable Per-pathogen Microbiologic Responses at End of Treatment (EOT) Visit in Extended Microbiologically Evaluable at End of Treatment Analysis Set | Pseudomonas aeruginosa (n=50, 41) | 24 participants with favorable responses |
Secondary
The Number of Favorable Per-pathogen Microbiologic Responses at End of Treatment (EOT) Visit in Microbiologically Evaluable at End of Treatment Analysis Set
The number of patients with a favorable per-pathogen microbiological response: favorable microbiological response includes: Eradication where, source specimen demonstrates absence of the original baseline pathogen. Presumed eradication where, source specimen was not available to culture and the patient was assessed as a clinical cure.
Time frame: Patients were followed after the last IV dose but no later than 24 hours after the last IV dose.
Population: The microbiologically evaluable (ME) analysis sets defined as all patients in clinically evaluable (CE) analysis set with at least 1 etiologic pathogen from an adequate baseline culture that is susceptible to both study agents (CAZ-AVI and meropenem). (pathogens in ≥10 patients)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CAZ-AVI | The Number of Favorable Per-pathogen Microbiologic Responses at End of Treatment (EOT) Visit in Microbiologically Evaluable at End of Treatment Analysis Set | Enterobacter cloacae (n=22, 17) | 22 participants with favorable responses |
| CAZ-AVI | The Number of Favorable Per-pathogen Microbiologic Responses at End of Treatment (EOT) Visit in Microbiologically Evaluable at End of Treatment Analysis Set | Staphylococcus aureus (n=16, 23) | 14 participants with favorable responses |
| CAZ-AVI | The Number of Favorable Per-pathogen Microbiologic Responses at End of Treatment (EOT) Visit in Microbiologically Evaluable at End of Treatment Analysis Set | Escherichia coli (n=13, 18) | 13 participants with favorable responses |
| CAZ-AVI | The Number of Favorable Per-pathogen Microbiologic Responses at End of Treatment (EOT) Visit in Microbiologically Evaluable at End of Treatment Analysis Set | Pseudomonas aeruginosa (n=38, 34) | 22 participants with favorable responses |
| CAZ-AVI | The Number of Favorable Per-pathogen Microbiologic Responses at End of Treatment (EOT) Visit in Microbiologically Evaluable at End of Treatment Analysis Set | Klebsiella pneumoniae (n=45, 55) | 38 participants with favorable responses |
| CAZ-AVI | The Number of Favorable Per-pathogen Microbiologic Responses at End of Treatment (EOT) Visit in Microbiologically Evaluable at End of Treatment Analysis Set | Enterobacter aerogenes (n=6, 7) | 4 participants with favorable responses |
| CAZ-AVI | The Number of Favorable Per-pathogen Microbiologic Responses at End of Treatment (EOT) Visit in Microbiologically Evaluable at End of Treatment Analysis Set | Proteus mirabilis (n=9, 8) | 8 participants with favorable responses |
| CAZ-AVI | The Number of Favorable Per-pathogen Microbiologic Responses at End of Treatment (EOT) Visit in Microbiologically Evaluable at End of Treatment Analysis Set | Haemophilus influenzae (n=12, 15) | 12 participants with favorable responses |
| CAZ-AVI | The Number of Favorable Per-pathogen Microbiologic Responses at End of Treatment (EOT) Visit in Microbiologically Evaluable at End of Treatment Analysis Set | Serratia marcescens (n=13, 10) | 12 participants with favorable responses |
| Meropenem | The Number of Favorable Per-pathogen Microbiologic Responses at End of Treatment (EOT) Visit in Microbiologically Evaluable at End of Treatment Analysis Set | Haemophilus influenzae (n=12, 15) | 15 participants with favorable responses |
| Meropenem | The Number of Favorable Per-pathogen Microbiologic Responses at End of Treatment (EOT) Visit in Microbiologically Evaluable at End of Treatment Analysis Set | Serratia marcescens (n=13, 10) | 8 participants with favorable responses |
| Meropenem | The Number of Favorable Per-pathogen Microbiologic Responses at End of Treatment (EOT) Visit in Microbiologically Evaluable at End of Treatment Analysis Set | Pseudomonas aeruginosa (n=38, 34) | 19 participants with favorable responses |
| Meropenem | The Number of Favorable Per-pathogen Microbiologic Responses at End of Treatment (EOT) Visit in Microbiologically Evaluable at End of Treatment Analysis Set | Staphylococcus aureus (n=16, 23) | 22 participants with favorable responses |
| Meropenem | The Number of Favorable Per-pathogen Microbiologic Responses at End of Treatment (EOT) Visit in Microbiologically Evaluable at End of Treatment Analysis Set | Enterobacter aerogenes (n=6, 7) | 5 participants with favorable responses |
| Meropenem | The Number of Favorable Per-pathogen Microbiologic Responses at End of Treatment (EOT) Visit in Microbiologically Evaluable at End of Treatment Analysis Set | Enterobacter cloacae (n=22, 17) | 17 participants with favorable responses |
| Meropenem | The Number of Favorable Per-pathogen Microbiologic Responses at End of Treatment (EOT) Visit in Microbiologically Evaluable at End of Treatment Analysis Set | Escherichia coli (n=13, 18) | 17 participants with favorable responses |
| Meropenem | The Number of Favorable Per-pathogen Microbiologic Responses at End of Treatment (EOT) Visit in Microbiologically Evaluable at End of Treatment Analysis Set | Klebsiella pneumoniae (n=45, 55) | 51 participants with favorable responses |
| Meropenem | The Number of Favorable Per-pathogen Microbiologic Responses at End of Treatment (EOT) Visit in Microbiologically Evaluable at End of Treatment Analysis Set | Proteus mirabilis (n=9, 8) | 6 participants with favorable responses |
Secondary
The Number of Favorable Per-pathogen Microbiologic Responses at End of Treatment (EOT) Visit in Microbiologically Modified Intent-to-treat Analysis Set at End of Treatment Visit
The number of patients with a favorable per-pathogen microbiological response: favorable microbiological response includes: Eradication where, source specimen demonstrates absence of the original baseline pathogen. Presumed eradication where, source specimen was not available to culture and the patient was assessed as a clinical cure.
Time frame: Patients were followed after the last IV dose but no later than 24 hours after the last IV dose.
Population: The microbiological modified intent-to-treat (mMITT) analysis set included all patients who met the minimum disease criteria and received any amount of study treatment, and had at least one study-qualifying Gram-negative baseline pathogen. (pathogens in ≥10 patients)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CAZ-AVI | The Number of Favorable Per-pathogen Microbiologic Responses at End of Treatment (EOT) Visit in Microbiologically Modified Intent-to-treat Analysis Set at End of Treatment Visit | Serratia marcescens (n=15, 13) | 12 participants with favorable responses |
| CAZ-AVI | The Number of Favorable Per-pathogen Microbiologic Responses at End of Treatment (EOT) Visit in Microbiologically Modified Intent-to-treat Analysis Set at End of Treatment Visit | Escherichia coli (n=17, 20) | 15 participants with favorable responses |
| CAZ-AVI | The Number of Favorable Per-pathogen Microbiologic Responses at End of Treatment (EOT) Visit in Microbiologically Modified Intent-to-treat Analysis Set at End of Treatment Visit | Haemophilus influenzae (n=16, 25) | 15 participants with favorable responses |
| CAZ-AVI | The Number of Favorable Per-pathogen Microbiologic Responses at End of Treatment (EOT) Visit in Microbiologically Modified Intent-to-treat Analysis Set at End of Treatment Visit | Pseudomonas aeruginosa (n=58, 47) | 33 participants with favorable responses |
| CAZ-AVI | The Number of Favorable Per-pathogen Microbiologic Responses at End of Treatment (EOT) Visit in Microbiologically Modified Intent-to-treat Analysis Set at End of Treatment Visit | Staphylococcus aureus (n=24, 34) | 21 participants with favorable responses |
| CAZ-AVI | The Number of Favorable Per-pathogen Microbiologic Responses at End of Treatment (EOT) Visit in Microbiologically Modified Intent-to-treat Analysis Set at End of Treatment Visit | Enterobacter cloacae (n=26, 22) | 25 participants with favorable responses |
| CAZ-AVI | The Number of Favorable Per-pathogen Microbiologic Responses at End of Treatment (EOT) Visit in Microbiologically Modified Intent-to-treat Analysis Set at End of Treatment Visit | Klebsiella pneumoniae (n=59, 71) | 49 participants with favorable responses |
| CAZ-AVI | The Number of Favorable Per-pathogen Microbiologic Responses at End of Treatment (EOT) Visit in Microbiologically Modified Intent-to-treat Analysis Set at End of Treatment Visit | Proteus mirabilis (n=14, 12) | 12 participants with favorable responses |
| CAZ-AVI | The Number of Favorable Per-pathogen Microbiologic Responses at End of Treatment (EOT) Visit in Microbiologically Modified Intent-to-treat Analysis Set at End of Treatment Visit | Enterobacter aerogenes (n=8, 8) | 6 participants with favorable responses |
| Meropenem | The Number of Favorable Per-pathogen Microbiologic Responses at End of Treatment (EOT) Visit in Microbiologically Modified Intent-to-treat Analysis Set at End of Treatment Visit | Proteus mirabilis (n=14, 12) | 10 participants with favorable responses |
| Meropenem | The Number of Favorable Per-pathogen Microbiologic Responses at End of Treatment (EOT) Visit in Microbiologically Modified Intent-to-treat Analysis Set at End of Treatment Visit | Enterobacter aerogenes (n=8, 8) | 5 participants with favorable responses |
| Meropenem | The Number of Favorable Per-pathogen Microbiologic Responses at End of Treatment (EOT) Visit in Microbiologically Modified Intent-to-treat Analysis Set at End of Treatment Visit | Staphylococcus aureus (n=24, 34) | 32 participants with favorable responses |
| Meropenem | The Number of Favorable Per-pathogen Microbiologic Responses at End of Treatment (EOT) Visit in Microbiologically Modified Intent-to-treat Analysis Set at End of Treatment Visit | Escherichia coli (n=17, 20) | 18 participants with favorable responses |
| Meropenem | The Number of Favorable Per-pathogen Microbiologic Responses at End of Treatment (EOT) Visit in Microbiologically Modified Intent-to-treat Analysis Set at End of Treatment Visit | Serratia marcescens (n=15, 13) | 11 participants with favorable responses |
| Meropenem | The Number of Favorable Per-pathogen Microbiologic Responses at End of Treatment (EOT) Visit in Microbiologically Modified Intent-to-treat Analysis Set at End of Treatment Visit | Klebsiella pneumoniae (n=59, 71) | 65 participants with favorable responses |
| Meropenem | The Number of Favorable Per-pathogen Microbiologic Responses at End of Treatment (EOT) Visit in Microbiologically Modified Intent-to-treat Analysis Set at End of Treatment Visit | Haemophilus influenzae (n=16, 25) | 25 participants with favorable responses |
| Meropenem | The Number of Favorable Per-pathogen Microbiologic Responses at End of Treatment (EOT) Visit in Microbiologically Modified Intent-to-treat Analysis Set at End of Treatment Visit | Enterobacter cloacae (n=26, 22) | 20 participants with favorable responses |
| Meropenem | The Number of Favorable Per-pathogen Microbiologic Responses at End of Treatment (EOT) Visit in Microbiologically Modified Intent-to-treat Analysis Set at End of Treatment Visit | Pseudomonas aeruginosa (n=58, 47) | 27 participants with favorable responses |
Secondary
The Number of Favorable Per-pathogen Microbiologic Responses at Test-of-cure (TOC) Visit in Extended Microbiologically Evaluable at Test-of-cure Analysis Set
The number of patients with a favorable per-pathogen microbiological response: favorable microbiological response includes: Eradication where, source specimen demonstrates absence of the original baseline pathogen. Presumed eradication where, source specimen was not available to culture and the patient was assessed as a clinical cure.
Time frame: At the test-of-cure (TOC) visit (Day 21 to 25)
Population: The extended-ME (EME) analysis set defined as all patients in clinically evaluable (CE) analysis set with at least 1 etiologic pathogen from an adequate baseline culture regardless of susceptibility to study agents. (pathogens in ≥10 patients)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CAZ-AVI | The Number of Favorable Per-pathogen Microbiologic Responses at Test-of-cure (TOC) Visit in Extended Microbiologically Evaluable at Test-of-cure Analysis Set | Enterobacter aerogenes (n=6, 5) | 5 participants with favorable responses |
| CAZ-AVI | The Number of Favorable Per-pathogen Microbiologic Responses at Test-of-cure (TOC) Visit in Extended Microbiologically Evaluable at Test-of-cure Analysis Set | Escherichia coli (n=11, 18) | 10 participants with favorable responses |
| CAZ-AVI | The Number of Favorable Per-pathogen Microbiologic Responses at Test-of-cure (TOC) Visit in Extended Microbiologically Evaluable at Test-of-cure Analysis Set | Proteus mirabilis (n=11, 8) | 9 participants with favorable responses |
| CAZ-AVI | The Number of Favorable Per-pathogen Microbiologic Responses at Test-of-cure (TOC) Visit in Extended Microbiologically Evaluable at Test-of-cure Analysis Set | Klebsiella pneumoniae (n=37, 49) | 29 participants with favorable responses |
| CAZ-AVI | The Number of Favorable Per-pathogen Microbiologic Responses at Test-of-cure (TOC) Visit in Extended Microbiologically Evaluable at Test-of-cure Analysis Set | Haemophilus influenzae (n=11, 13) | 11 participants with favorable responses |
| CAZ-AVI | The Number of Favorable Per-pathogen Microbiologic Responses at Test-of-cure (TOC) Visit in Extended Microbiologically Evaluable at Test-of-cure Analysis Set | Pseudomonas aeruginosa (n=42, 35) | 18 participants with favorable responses |
| CAZ-AVI | The Number of Favorable Per-pathogen Microbiologic Responses at Test-of-cure (TOC) Visit in Extended Microbiologically Evaluable at Test-of-cure Analysis Set | Serratia marcescens (n=12, 8) | 9 participants with favorable responses |
| CAZ-AVI | The Number of Favorable Per-pathogen Microbiologic Responses at Test-of-cure (TOC) Visit in Extended Microbiologically Evaluable at Test-of-cure Analysis Set | Staphylococcus aureus (n=14, 22) | 5 participants with favorable responses |
| CAZ-AVI | The Number of Favorable Per-pathogen Microbiologic Responses at Test-of-cure (TOC) Visit in Extended Microbiologically Evaluable at Test-of-cure Analysis Set | Enterobacter cloacae (n=21, 11) | 18 participants with favorable responses |
| Meropenem | The Number of Favorable Per-pathogen Microbiologic Responses at Test-of-cure (TOC) Visit in Extended Microbiologically Evaluable at Test-of-cure Analysis Set | Staphylococcus aureus (n=14, 22) | 17 participants with favorable responses |
| Meropenem | The Number of Favorable Per-pathogen Microbiologic Responses at Test-of-cure (TOC) Visit in Extended Microbiologically Evaluable at Test-of-cure Analysis Set | Enterobacter cloacae (n=21, 11) | 7 participants with favorable responses |
| Meropenem | The Number of Favorable Per-pathogen Microbiologic Responses at Test-of-cure (TOC) Visit in Extended Microbiologically Evaluable at Test-of-cure Analysis Set | Klebsiella pneumoniae (n=37, 49) | 39 participants with favorable responses |
| Meropenem | The Number of Favorable Per-pathogen Microbiologic Responses at Test-of-cure (TOC) Visit in Extended Microbiologically Evaluable at Test-of-cure Analysis Set | Proteus mirabilis (n=11, 8) | 6 participants with favorable responses |
| Meropenem | The Number of Favorable Per-pathogen Microbiologic Responses at Test-of-cure (TOC) Visit in Extended Microbiologically Evaluable at Test-of-cure Analysis Set | Haemophilus influenzae (n=11, 13) | 12 participants with favorable responses |
| Meropenem | The Number of Favorable Per-pathogen Microbiologic Responses at Test-of-cure (TOC) Visit in Extended Microbiologically Evaluable at Test-of-cure Analysis Set | Escherichia coli (n=11, 18) | 16 participants with favorable responses |
| Meropenem | The Number of Favorable Per-pathogen Microbiologic Responses at Test-of-cure (TOC) Visit in Extended Microbiologically Evaluable at Test-of-cure Analysis Set | Serratia marcescens (n=12, 8) | 5 participants with favorable responses |
| Meropenem | The Number of Favorable Per-pathogen Microbiologic Responses at Test-of-cure (TOC) Visit in Extended Microbiologically Evaluable at Test-of-cure Analysis Set | Pseudomonas aeruginosa (n=42, 35) | 14 participants with favorable responses |
| Meropenem | The Number of Favorable Per-pathogen Microbiologic Responses at Test-of-cure (TOC) Visit in Extended Microbiologically Evaluable at Test-of-cure Analysis Set | Enterobacter aerogenes (n=6, 5) | 3 participants with favorable responses |
Secondary
The Number of Favorable Per-pathogen Microbiologic Responses at Test-of-cure (TOC) Visit in Microbiologically Evaluable at Test-of-cure Analysis Set
The number of patients with a favorable per-pathogen microbiological response: favorable microbiological response includes: Eradication where, source specimen demonstrates absence of the original baseline pathogen. Presumed eradication where, source specimen was not available to culture and the patient was assessed as a clinical cure.
Time frame: At the test-of-cure (TOC) visit (Day 21 to 25)
Population: The microbiologically evaluable (ME) analysis sets defined as all patients in clinically evaluable (CE) analysis set with at least 1 etiologic pathogen from an adequate baseline culture that is susceptible to both study agents (CAZ-AVI and meropenem). (pathogens in ≥10 patients)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CAZ-AVI | The Number of Favorable Per-pathogen Microbiologic Responses at Test-of-cure (TOC) Visit in Microbiologically Evaluable at Test-of-cure Analysis Set | Escherichia coli (n=10, 18) | 10 participants with favorable responses |
| CAZ-AVI | The Number of Favorable Per-pathogen Microbiologic Responses at Test-of-cure (TOC) Visit in Microbiologically Evaluable at Test-of-cure Analysis Set | Serratia marcescens (n=12, 8) | 9 participants with favorable responses |
| CAZ-AVI | The Number of Favorable Per-pathogen Microbiologic Responses at Test-of-cure (TOC) Visit in Microbiologically Evaluable at Test-of-cure Analysis Set | Enterobacter aerogenes (n=6, 5) | 5 participants with favorable responses |
| CAZ-AVI | The Number of Favorable Per-pathogen Microbiologic Responses at Test-of-cure (TOC) Visit in Microbiologically Evaluable at Test-of-cure Analysis Set | Haemophilus influenzae (n=9, 12) | 9 participants with favorable responses |
| CAZ-AVI | The Number of Favorable Per-pathogen Microbiologic Responses at Test-of-cure (TOC) Visit in Microbiologically Evaluable at Test-of-cure Analysis Set | Klebsiella pneumoniae (n=37, 47) | 29 participants with favorable responses |
| CAZ-AVI | The Number of Favorable Per-pathogen Microbiologic Responses at Test-of-cure (TOC) Visit in Microbiologically Evaluable at Test-of-cure Analysis Set | Pseudomonas aeruginosa (n=31, 28) | 13 participants with favorable responses |
| CAZ-AVI | The Number of Favorable Per-pathogen Microbiologic Responses at Test-of-cure (TOC) Visit in Microbiologically Evaluable at Test-of-cure Analysis Set | Enterobacter cloacae (n=21, 11) | 18 participants with favorable responses |
| CAZ-AVI | The Number of Favorable Per-pathogen Microbiologic Responses at Test-of-cure (TOC) Visit in Microbiologically Evaluable at Test-of-cure Analysis Set | Staphylococcus aureus (n=13, 19) | 4 participants with favorable responses |
| CAZ-AVI | The Number of Favorable Per-pathogen Microbiologic Responses at Test-of-cure (TOC) Visit in Microbiologically Evaluable at Test-of-cure Analysis Set | Proteus mirabilis (n=11, 8) | 9 participants with favorable responses |
| Meropenem | The Number of Favorable Per-pathogen Microbiologic Responses at Test-of-cure (TOC) Visit in Microbiologically Evaluable at Test-of-cure Analysis Set | Staphylococcus aureus (n=13, 19) | 15 participants with favorable responses |
| Meropenem | The Number of Favorable Per-pathogen Microbiologic Responses at Test-of-cure (TOC) Visit in Microbiologically Evaluable at Test-of-cure Analysis Set | Enterobacter aerogenes (n=6, 5) | 3 participants with favorable responses |
| Meropenem | The Number of Favorable Per-pathogen Microbiologic Responses at Test-of-cure (TOC) Visit in Microbiologically Evaluable at Test-of-cure Analysis Set | Escherichia coli (n=10, 18) | 16 participants with favorable responses |
| Meropenem | The Number of Favorable Per-pathogen Microbiologic Responses at Test-of-cure (TOC) Visit in Microbiologically Evaluable at Test-of-cure Analysis Set | Klebsiella pneumoniae (n=37, 47) | 38 participants with favorable responses |
| Meropenem | The Number of Favorable Per-pathogen Microbiologic Responses at Test-of-cure (TOC) Visit in Microbiologically Evaluable at Test-of-cure Analysis Set | Proteus mirabilis (n=11, 8) | 6 participants with favorable responses |
| Meropenem | The Number of Favorable Per-pathogen Microbiologic Responses at Test-of-cure (TOC) Visit in Microbiologically Evaluable at Test-of-cure Analysis Set | Serratia marcescens (n=12, 8) | 5 participants with favorable responses |
| Meropenem | The Number of Favorable Per-pathogen Microbiologic Responses at Test-of-cure (TOC) Visit in Microbiologically Evaluable at Test-of-cure Analysis Set | Haemophilus influenzae (n=9, 12) | 11 participants with favorable responses |
| Meropenem | The Number of Favorable Per-pathogen Microbiologic Responses at Test-of-cure (TOC) Visit in Microbiologically Evaluable at Test-of-cure Analysis Set | Pseudomonas aeruginosa (n=31, 28) | 12 participants with favorable responses |
| Meropenem | The Number of Favorable Per-pathogen Microbiologic Responses at Test-of-cure (TOC) Visit in Microbiologically Evaluable at Test-of-cure Analysis Set | Enterobacter cloacae (n=21, 11) | 7 participants with favorable responses |
Secondary
The Number of Favorable Per-pathogen Microbiologic Responses at Test-of-cure (TOC) Visit in Microbiologically Modified Intent-to-treat Analysis Set at Test-of-cure Visit
The number of patients with a favorable per-pathogen microbiological response: favorable microbiological response includes: Eradication where, source specimen demonstrates absence of the original baseline pathogen. Presumed eradication where, source specimen was not available to culture and the patient was assessed as a clinical cure.
Time frame: At the test-of-cure (TOC) visit (Day 21 to 25)
Population: The microbiological modified intent-to-treat (mMITT) analysis set included all patients who met the minimum disease criteria and received any amount of study treatment, and had at least one study-qualifying Gram-negative baseline pathogen. (pathogens in ≥10 patients)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CAZ-AVI | The Number of Favorable Per-pathogen Microbiologic Responses at Test-of-cure (TOC) Visit in Microbiologically Modified Intent-to-treat Analysis Set at Test-of-cure Visit | Pseudomonas aeruginosa (n=58, 47) | 22 participants with favorable responses |
| CAZ-AVI | The Number of Favorable Per-pathogen Microbiologic Responses at Test-of-cure (TOC) Visit in Microbiologically Modified Intent-to-treat Analysis Set at Test-of-cure Visit | Klebsiella pneumoniae (n=59, 71) | 37 participants with favorable responses |
| CAZ-AVI | The Number of Favorable Per-pathogen Microbiologic Responses at Test-of-cure (TOC) Visit in Microbiologically Modified Intent-to-treat Analysis Set at Test-of-cure Visit | Enterobacter aerogenes (n=8, 8) | 5 participants with favorable responses |
| CAZ-AVI | The Number of Favorable Per-pathogen Microbiologic Responses at Test-of-cure (TOC) Visit in Microbiologically Modified Intent-to-treat Analysis Set at Test-of-cure Visit | Proteus mirabilis (n=14, 12) | 11 participants with favorable responses |
| CAZ-AVI | The Number of Favorable Per-pathogen Microbiologic Responses at Test-of-cure (TOC) Visit in Microbiologically Modified Intent-to-treat Analysis Set at Test-of-cure Visit | Escherichia coli (n=17, 20) | 13 participants with favorable responses |
| CAZ-AVI | The Number of Favorable Per-pathogen Microbiologic Responses at Test-of-cure (TOC) Visit in Microbiologically Modified Intent-to-treat Analysis Set at Test-of-cure Visit | Serratia marcescens (n=15, 13) | 10 participants with favorable responses |
| CAZ-AVI | The Number of Favorable Per-pathogen Microbiologic Responses at Test-of-cure (TOC) Visit in Microbiologically Modified Intent-to-treat Analysis Set at Test-of-cure Visit | Haemophilus influenzae (n=16, 25) | 14 participants with favorable responses |
| CAZ-AVI | The Number of Favorable Per-pathogen Microbiologic Responses at Test-of-cure (TOC) Visit in Microbiologically Modified Intent-to-treat Analysis Set at Test-of-cure Visit | Staphylococcus aureus (n=24, 34) | 11 participants with favorable responses |
| CAZ-AVI | The Number of Favorable Per-pathogen Microbiologic Responses at Test-of-cure (TOC) Visit in Microbiologically Modified Intent-to-treat Analysis Set at Test-of-cure Visit | Enterobacter cloacae (n=26, 22) | 21 participants with favorable responses |
| Meropenem | The Number of Favorable Per-pathogen Microbiologic Responses at Test-of-cure (TOC) Visit in Microbiologically Modified Intent-to-treat Analysis Set at Test-of-cure Visit | Staphylococcus aureus (n=24, 34) | 25 participants with favorable responses |
| Meropenem | The Number of Favorable Per-pathogen Microbiologic Responses at Test-of-cure (TOC) Visit in Microbiologically Modified Intent-to-treat Analysis Set at Test-of-cure Visit | Enterobacter cloacae (n=26, 22) | 13 participants with favorable responses |
| Meropenem | The Number of Favorable Per-pathogen Microbiologic Responses at Test-of-cure (TOC) Visit in Microbiologically Modified Intent-to-treat Analysis Set at Test-of-cure Visit | Escherichia coli (n=17, 20) | 16 participants with favorable responses |
| Meropenem | The Number of Favorable Per-pathogen Microbiologic Responses at Test-of-cure (TOC) Visit in Microbiologically Modified Intent-to-treat Analysis Set at Test-of-cure Visit | Klebsiella pneumoniae (n=59, 71) | 53 participants with favorable responses |
| Meropenem | The Number of Favorable Per-pathogen Microbiologic Responses at Test-of-cure (TOC) Visit in Microbiologically Modified Intent-to-treat Analysis Set at Test-of-cure Visit | Haemophilus influenzae (n=16, 25) | 23 participants with favorable responses |
| Meropenem | The Number of Favorable Per-pathogen Microbiologic Responses at Test-of-cure (TOC) Visit in Microbiologically Modified Intent-to-treat Analysis Set at Test-of-cure Visit | Pseudomonas aeruginosa (n=58, 47) | 18 participants with favorable responses |
| Meropenem | The Number of Favorable Per-pathogen Microbiologic Responses at Test-of-cure (TOC) Visit in Microbiologically Modified Intent-to-treat Analysis Set at Test-of-cure Visit | Proteus mirabilis (n=14, 12) | 8 participants with favorable responses |
| Meropenem | The Number of Favorable Per-pathogen Microbiologic Responses at Test-of-cure (TOC) Visit in Microbiologically Modified Intent-to-treat Analysis Set at Test-of-cure Visit | Serratia marcescens (n=15, 13) | 8 participants with favorable responses |
| Meropenem | The Number of Favorable Per-pathogen Microbiologic Responses at Test-of-cure (TOC) Visit in Microbiologically Modified Intent-to-treat Analysis Set at Test-of-cure Visit | Enterobacter aerogenes (n=8, 8) | 5 participants with favorable responses |
Secondary
The Number of Favorable Per-pathogen Microbiologic Responses in Patients With Pathogens Resistant to Ceftazidime at End of Treatment (EOT) Visit in Extended Microbiologically Evaluable at End of Treatment Analysis Set
The number of patients with a favorable per-pathogen microbiological response: favorable microbiological response includes: Eradication where, source specimen demonstrates absence of the original baseline pathogen. Presumed eradication where, source specimen was not available to culture and the patient was assessed as a clinical cure.
Time frame: Patients were followed after the last IV dose but no later than 24 hours after the last IV dose.
Population: The extended-ME (EME) analysis set defined as all patients in clinically evaluable (CE) analysis set with at least 1 etiologic pathogen from an adequate baseline culture regardless of susceptibility to study agents. Patients infected with ceftazidime-resistant Gram negative pathogens at EOT (pathogens in ≥5 patients)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CAZ-AVI | The Number of Favorable Per-pathogen Microbiologic Responses in Patients With Pathogens Resistant to Ceftazidime at End of Treatment (EOT) Visit in Extended Microbiologically Evaluable at End of Treatment Analysis Set | Escherichia coli (n=6, 4) | 5 participants with favorable responses |
| CAZ-AVI | The Number of Favorable Per-pathogen Microbiologic Responses in Patients With Pathogens Resistant to Ceftazidime at End of Treatment (EOT) Visit in Extended Microbiologically Evaluable at End of Treatment Analysis Set | Enterobacter aerogenes (n=4, 2) | 3 participants with favorable responses |
| CAZ-AVI | The Number of Favorable Per-pathogen Microbiologic Responses in Patients With Pathogens Resistant to Ceftazidime at End of Treatment (EOT) Visit in Extended Microbiologically Evaluable at End of Treatment Analysis Set | Klebsiella pneumoniae (n=16, 28) | 14 participants with favorable responses |
| CAZ-AVI | The Number of Favorable Per-pathogen Microbiologic Responses in Patients With Pathogens Resistant to Ceftazidime at End of Treatment (EOT) Visit in Extended Microbiologically Evaluable at End of Treatment Analysis Set | Enterobacter cloacae (n=6, 5) | 6 participants with favorable responses |
| CAZ-AVI | The Number of Favorable Per-pathogen Microbiologic Responses in Patients With Pathogens Resistant to Ceftazidime at End of Treatment (EOT) Visit in Extended Microbiologically Evaluable at End of Treatment Analysis Set | Pseudomonas aeruginosa (n=10, 13) | 8 participants with favorable responses |
| Meropenem | The Number of Favorable Per-pathogen Microbiologic Responses in Patients With Pathogens Resistant to Ceftazidime at End of Treatment (EOT) Visit in Extended Microbiologically Evaluable at End of Treatment Analysis Set | Pseudomonas aeruginosa (n=10, 13) | 6 participants with favorable responses |
| Meropenem | The Number of Favorable Per-pathogen Microbiologic Responses in Patients With Pathogens Resistant to Ceftazidime at End of Treatment (EOT) Visit in Extended Microbiologically Evaluable at End of Treatment Analysis Set | Enterobacter cloacae (n=6, 5) | 5 participants with favorable responses |
| Meropenem | The Number of Favorable Per-pathogen Microbiologic Responses in Patients With Pathogens Resistant to Ceftazidime at End of Treatment (EOT) Visit in Extended Microbiologically Evaluable at End of Treatment Analysis Set | Escherichia coli (n=6, 4) | 4 participants with favorable responses |
| Meropenem | The Number of Favorable Per-pathogen Microbiologic Responses in Patients With Pathogens Resistant to Ceftazidime at End of Treatment (EOT) Visit in Extended Microbiologically Evaluable at End of Treatment Analysis Set | Enterobacter aerogenes (n=4, 2) | 2 participants with favorable responses |
| Meropenem | The Number of Favorable Per-pathogen Microbiologic Responses in Patients With Pathogens Resistant to Ceftazidime at End of Treatment (EOT) Visit in Extended Microbiologically Evaluable at End of Treatment Analysis Set | Klebsiella pneumoniae (n=16, 28) | 25 participants with favorable responses |
Secondary
The Number of Favorable Per-pathogen Microbiologic Responses in Patients With Pathogens Resistant to Ceftazidime at End of Treatment (EOT) Visit in Microbiologically Evaluable at End of Treatment Analysis Set
The number of patients with a favorable per-pathogen microbiological response: favorable microbiological response includes: Eradication where, source specimen demonstrates absence of the original baseline pathogen. Presumed eradication where, source specimen was not available to culture and the patient was assessed as a clinical cure.
Time frame: Patients were followed after the last IV dose but no later than 24 hours after the last IV dose.
Population: Microbiologically evaluable (ME) analysis sets defined as all patients in clinically evaluable (CE) analysis set with at least 1 etiologic pathogen from an adequate baseline culture that is susceptible to both study agents (CAZ-AVI and meropenem). Patients infected with ceftazidime-resistant Gram negative pathogens at EOT (pathogens in ≥5 patients)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CAZ-AVI | The Number of Favorable Per-pathogen Microbiologic Responses in Patients With Pathogens Resistant to Ceftazidime at End of Treatment (EOT) Visit in Microbiologically Evaluable at End of Treatment Analysis Set | Escherichia coli (n=5, 4) | 5 participants with favorable responses |
| CAZ-AVI | The Number of Favorable Per-pathogen Microbiologic Responses in Patients With Pathogens Resistant to Ceftazidime at End of Treatment (EOT) Visit in Microbiologically Evaluable at End of Treatment Analysis Set | Pseudomonas aeruginosa (n=4, 6) | 3 participants with favorable responses |
| CAZ-AVI | The Number of Favorable Per-pathogen Microbiologic Responses in Patients With Pathogens Resistant to Ceftazidime at End of Treatment (EOT) Visit in Microbiologically Evaluable at End of Treatment Analysis Set | Enterobacter cloacae (n=6, 5) | 6 participants with favorable responses |
| CAZ-AVI | The Number of Favorable Per-pathogen Microbiologic Responses in Patients With Pathogens Resistant to Ceftazidime at End of Treatment (EOT) Visit in Microbiologically Evaluable at End of Treatment Analysis Set | Klebsiella pneumoniae (n=16, 26) | 14 participants with favorable responses |
| CAZ-AVI | The Number of Favorable Per-pathogen Microbiologic Responses in Patients With Pathogens Resistant to Ceftazidime at End of Treatment (EOT) Visit in Microbiologically Evaluable at End of Treatment Analysis Set | Enterobacter aerogenes (n=4, 2) | 3 participants with favorable responses |
| Meropenem | The Number of Favorable Per-pathogen Microbiologic Responses in Patients With Pathogens Resistant to Ceftazidime at End of Treatment (EOT) Visit in Microbiologically Evaluable at End of Treatment Analysis Set | Enterobacter cloacae (n=6, 5) | 5 participants with favorable responses |
| Meropenem | The Number of Favorable Per-pathogen Microbiologic Responses in Patients With Pathogens Resistant to Ceftazidime at End of Treatment (EOT) Visit in Microbiologically Evaluable at End of Treatment Analysis Set | Escherichia coli (n=5, 4) | 4 participants with favorable responses |
| Meropenem | The Number of Favorable Per-pathogen Microbiologic Responses in Patients With Pathogens Resistant to Ceftazidime at End of Treatment (EOT) Visit in Microbiologically Evaluable at End of Treatment Analysis Set | Klebsiella pneumoniae (n=16, 26) | 23 participants with favorable responses |
| Meropenem | The Number of Favorable Per-pathogen Microbiologic Responses in Patients With Pathogens Resistant to Ceftazidime at End of Treatment (EOT) Visit in Microbiologically Evaluable at End of Treatment Analysis Set | Pseudomonas aeruginosa (n=4, 6) | 1 participants with favorable responses |
| Meropenem | The Number of Favorable Per-pathogen Microbiologic Responses in Patients With Pathogens Resistant to Ceftazidime at End of Treatment (EOT) Visit in Microbiologically Evaluable at End of Treatment Analysis Set | Enterobacter aerogenes (n=4, 2) | 2 participants with favorable responses |
Secondary
The Number of Favorable Per-pathogen Microbiologic Responses in Patients With Pathogens Resistant to Ceftazidime at End of Treatment (EOT) Visit in Microbiologically Modified Intent-to-treat Analysis Set at End of Treatment Visit
The number of patients with a favorable per-pathogen microbiological response: favorable microbiological response includes: Eradication where, source specimen demonstrates absence of the original baseline pathogen. Presumed eradication where, source specimen was not available to culture and the patient was assessed as a clinical cure.
Time frame: Patients were followed after the last IV dose but no later than 24 hours after the last IV dose.
Population: The microbiological modified intent-to-treat (mMITT) analysis set included all patients who met the minimum disease criteria and received any amount of study treatment, and had at least one study-qualifying Gram-negative baseline pathogen. Patients infected with ceftazidime-resistant Gram negative pathogens at EOT (pathogens in ≥5 patients)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CAZ-AVI | The Number of Favorable Per-pathogen Microbiologic Responses in Patients With Pathogens Resistant to Ceftazidime at End of Treatment (EOT) Visit in Microbiologically Modified Intent-to-treat Analysis Set at End of Treatment Visit | Pseudomonas aeruginosa (n=11, 15) | 8 participants with favorable responses |
| CAZ-AVI | The Number of Favorable Per-pathogen Microbiologic Responses in Patients With Pathogens Resistant to Ceftazidime at End of Treatment (EOT) Visit in Microbiologically Modified Intent-to-treat Analysis Set at End of Treatment Visit | Enterobacter cloacae (n=6, 6) | 6 participants with favorable responses |
| CAZ-AVI | The Number of Favorable Per-pathogen Microbiologic Responses in Patients With Pathogens Resistant to Ceftazidime at End of Treatment (EOT) Visit in Microbiologically Modified Intent-to-treat Analysis Set at End of Treatment Visit | Enterobacter aerogenes (n=4, 2) | 3 participants with favorable responses |
| CAZ-AVI | The Number of Favorable Per-pathogen Microbiologic Responses in Patients With Pathogens Resistant to Ceftazidime at End of Treatment (EOT) Visit in Microbiologically Modified Intent-to-treat Analysis Set at End of Treatment Visit | Escherichia coli (n=6, 5) | 5 participants with favorable responses |
| CAZ-AVI | The Number of Favorable Per-pathogen Microbiologic Responses in Patients With Pathogens Resistant to Ceftazidime at End of Treatment (EOT) Visit in Microbiologically Modified Intent-to-treat Analysis Set at End of Treatment Visit | Klebsiella pneumoniae (n=20, 30) | 18 participants with favorable responses |
| Meropenem | The Number of Favorable Per-pathogen Microbiologic Responses in Patients With Pathogens Resistant to Ceftazidime at End of Treatment (EOT) Visit in Microbiologically Modified Intent-to-treat Analysis Set at End of Treatment Visit | Escherichia coli (n=6, 5) | 4 participants with favorable responses |
| Meropenem | The Number of Favorable Per-pathogen Microbiologic Responses in Patients With Pathogens Resistant to Ceftazidime at End of Treatment (EOT) Visit in Microbiologically Modified Intent-to-treat Analysis Set at End of Treatment Visit | Klebsiella pneumoniae (n=20, 30) | 26 participants with favorable responses |
| Meropenem | The Number of Favorable Per-pathogen Microbiologic Responses in Patients With Pathogens Resistant to Ceftazidime at End of Treatment (EOT) Visit in Microbiologically Modified Intent-to-treat Analysis Set at End of Treatment Visit | Pseudomonas aeruginosa (n=11, 15) | 7 participants with favorable responses |
| Meropenem | The Number of Favorable Per-pathogen Microbiologic Responses in Patients With Pathogens Resistant to Ceftazidime at End of Treatment (EOT) Visit in Microbiologically Modified Intent-to-treat Analysis Set at End of Treatment Visit | Enterobacter aerogenes (n=4, 2) | 2 participants with favorable responses |
| Meropenem | The Number of Favorable Per-pathogen Microbiologic Responses in Patients With Pathogens Resistant to Ceftazidime at End of Treatment (EOT) Visit in Microbiologically Modified Intent-to-treat Analysis Set at End of Treatment Visit | Enterobacter cloacae (n=6, 6) | 6 participants with favorable responses |
Secondary
The Number of Favorable Per-pathogen Microbiologic Responses in Patients With Pathogens Resistant to Ceftazidime at Test-of-cure (TOC) Visit in Extended Microbiologically Evaluable at Test-of-cure Analysis Set
The number of patients with a favorable per-pathogen microbiological response: favorable microbiological response includes: Eradication where, source specimen demonstrates absence of the original baseline pathogen. Presumed eradication where, source specimen was not available to culture and the patient was assessed as a clinical cure.
Time frame: At the test-of-cure (TOC) visit (Day 21 to 25)
Population: The extended-ME (EME) analysis set defined as all patients in clinically evaluable (CE) analysis set with at least 1 etiologic pathogen from an adequate baseline culture regardless of susceptibility to study agents. Patients infected with ceftazidime-resistant Gram negative pathogens at TOC (pathogens in ≥5 patients)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CAZ-AVI | The Number of Favorable Per-pathogen Microbiologic Responses in Patients With Pathogens Resistant to Ceftazidime at Test-of-cure (TOC) Visit in Extended Microbiologically Evaluable at Test-of-cure Analysis Set | Enterobacter cloacae (n=5, 5) | 4 participants with favorable responses |
| CAZ-AVI | The Number of Favorable Per-pathogen Microbiologic Responses in Patients With Pathogens Resistant to Ceftazidime at Test-of-cure (TOC) Visit in Extended Microbiologically Evaluable at Test-of-cure Analysis Set | Escherichia coli (n=5, 4) | 4 participants with favorable responses |
| CAZ-AVI | The Number of Favorable Per-pathogen Microbiologic Responses in Patients With Pathogens Resistant to Ceftazidime at Test-of-cure (TOC) Visit in Extended Microbiologically Evaluable at Test-of-cure Analysis Set | Klebsiella pneumoniae (n=14, 22) | 11 participants with favorable responses |
| CAZ-AVI | The Number of Favorable Per-pathogen Microbiologic Responses in Patients With Pathogens Resistant to Ceftazidime at Test-of-cure (TOC) Visit in Extended Microbiologically Evaluable at Test-of-cure Analysis Set | Pseudomonas aeruginosa (n=9, 13) | 3 participants with favorable responses |
| Meropenem | The Number of Favorable Per-pathogen Microbiologic Responses in Patients With Pathogens Resistant to Ceftazidime at Test-of-cure (TOC) Visit in Extended Microbiologically Evaluable at Test-of-cure Analysis Set | Pseudomonas aeruginosa (n=9, 13) | 3 participants with favorable responses |
| Meropenem | The Number of Favorable Per-pathogen Microbiologic Responses in Patients With Pathogens Resistant to Ceftazidime at Test-of-cure (TOC) Visit in Extended Microbiologically Evaluable at Test-of-cure Analysis Set | Enterobacter cloacae (n=5, 5) | 4 participants with favorable responses |
| Meropenem | The Number of Favorable Per-pathogen Microbiologic Responses in Patients With Pathogens Resistant to Ceftazidime at Test-of-cure (TOC) Visit in Extended Microbiologically Evaluable at Test-of-cure Analysis Set | Klebsiella pneumoniae (n=14, 22) | 14 participants with favorable responses |
| Meropenem | The Number of Favorable Per-pathogen Microbiologic Responses in Patients With Pathogens Resistant to Ceftazidime at Test-of-cure (TOC) Visit in Extended Microbiologically Evaluable at Test-of-cure Analysis Set | Escherichia coli (n=5, 4) | 4 participants with favorable responses |
Secondary
The Number of Favorable Per-pathogen Microbiologic Responses in Patients With Pathogens Resistant to Ceftazidime at Test-of-cure (TOC) Visit in Microbiologically Evaluable at Test-of-cure Analysis Set
The number of patients with a favorable per-pathogen microbiological response: favorable microbiological response includes: Eradication where, source specimen demonstrates absence of the original baseline pathogen. Presumed eradication where, source specimen was not available to culture and the patient was assessed as a clinical cure.
Time frame: At the test-of-cure (TOC) visit (Day 21 to 25)
Population: Microbiologically evaluable (ME) analysis sets defined as all patients in clinically evaluable (CE) analysis set with at least 1 etiologic pathogen from an adequate baseline culture that is susceptible to both study agents (CAZ-AVI and meropenem). Patients infected with ceftazidime-resistant Gram negative pathogens at TOC (pathogens in ≥5 patients)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CAZ-AVI | The Number of Favorable Per-pathogen Microbiologic Responses in Patients With Pathogens Resistant to Ceftazidime at Test-of-cure (TOC) Visit in Microbiologically Evaluable at Test-of-cure Analysis Set | Enterobacter cloacae (n=5, 5) | 4 participants with favorable responses |
| CAZ-AVI | The Number of Favorable Per-pathogen Microbiologic Responses in Patients With Pathogens Resistant to Ceftazidime at Test-of-cure (TOC) Visit in Microbiologically Evaluable at Test-of-cure Analysis Set | Escherichia coli (n=4, 4) | 4 participants with favorable responses |
| CAZ-AVI | The Number of Favorable Per-pathogen Microbiologic Responses in Patients With Pathogens Resistant to Ceftazidime at Test-of-cure (TOC) Visit in Microbiologically Evaluable at Test-of-cure Analysis Set | Klebsiella pneumoniae (n=14, 20) | 11 participants with favorable responses |
| CAZ-AVI | The Number of Favorable Per-pathogen Microbiologic Responses in Patients With Pathogens Resistant to Ceftazidime at Test-of-cure (TOC) Visit in Microbiologically Evaluable at Test-of-cure Analysis Set | Pseudomonas aeruginosa (n=3, 6) | 1 participants with favorable responses |
| Meropenem | The Number of Favorable Per-pathogen Microbiologic Responses in Patients With Pathogens Resistant to Ceftazidime at Test-of-cure (TOC) Visit in Microbiologically Evaluable at Test-of-cure Analysis Set | Pseudomonas aeruginosa (n=3, 6) | 1 participants with favorable responses |
| Meropenem | The Number of Favorable Per-pathogen Microbiologic Responses in Patients With Pathogens Resistant to Ceftazidime at Test-of-cure (TOC) Visit in Microbiologically Evaluable at Test-of-cure Analysis Set | Enterobacter cloacae (n=5, 5) | 4 participants with favorable responses |
| Meropenem | The Number of Favorable Per-pathogen Microbiologic Responses in Patients With Pathogens Resistant to Ceftazidime at Test-of-cure (TOC) Visit in Microbiologically Evaluable at Test-of-cure Analysis Set | Klebsiella pneumoniae (n=14, 20) | 13 participants with favorable responses |
| Meropenem | The Number of Favorable Per-pathogen Microbiologic Responses in Patients With Pathogens Resistant to Ceftazidime at Test-of-cure (TOC) Visit in Microbiologically Evaluable at Test-of-cure Analysis Set | Escherichia coli (n=4, 4) | 4 participants with favorable responses |
Secondary
The Number of Favorable Per-pathogen Microbiologic Responses in Patients With Pathogens Resistant to Ceftazidime at Test-of-cure (TOC) Visit in Microbiologically Modified Intent-to-treat Analysis Set at Test-of-cure Visit
The number of patients with a favorable per-pathogen microbiological response: favorable microbiological response includes: Eradication where, source specimen demonstrates absence of the original baseline pathogen. Presumed eradication where, source specimen was not available to culture and the patient was assessed as a clinical cure.
Time frame: At the test-of-cure (TOC) visit (Day 21 to 25)
Population: The microbiological modified intent-to-treat (mMITT) analysis set included all patients who met the minimum disease criteria and received any amount of study treatment, and had at least one study-qualifying Gram-negative baseline pathogen. Patients infected with ceftazidime-resistant Gram negative pathogens at TOC (pathogens in ≥5 patients)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CAZ-AVI | The Number of Favorable Per-pathogen Microbiologic Responses in Patients With Pathogens Resistant to Ceftazidime at Test-of-cure (TOC) Visit in Microbiologically Modified Intent-to-treat Analysis Set at Test-of-cure Visit | Enterobacter cloacae (n=6, 6) | 5 participants with favorable responses |
| CAZ-AVI | The Number of Favorable Per-pathogen Microbiologic Responses in Patients With Pathogens Resistant to Ceftazidime at Test-of-cure (TOC) Visit in Microbiologically Modified Intent-to-treat Analysis Set at Test-of-cure Visit | Klebsiella pneumoniae (n=20, 30) | 15 participants with favorable responses |
| CAZ-AVI | The Number of Favorable Per-pathogen Microbiologic Responses in Patients With Pathogens Resistant to Ceftazidime at Test-of-cure (TOC) Visit in Microbiologically Modified Intent-to-treat Analysis Set at Test-of-cure Visit | Escherichia coli (n=6, 5) | 4 participants with favorable responses |
| CAZ-AVI | The Number of Favorable Per-pathogen Microbiologic Responses in Patients With Pathogens Resistant to Ceftazidime at Test-of-cure (TOC) Visit in Microbiologically Modified Intent-to-treat Analysis Set at Test-of-cure Visit | Pseudomonas aeruginosa (n=11, 15) | 4 participants with favorable responses |
| CAZ-AVI | The Number of Favorable Per-pathogen Microbiologic Responses in Patients With Pathogens Resistant to Ceftazidime at Test-of-cure (TOC) Visit in Microbiologically Modified Intent-to-treat Analysis Set at Test-of-cure Visit | Enterobacter aerogenes (n=4, 2) | 3 participants with favorable responses |
| Meropenem | The Number of Favorable Per-pathogen Microbiologic Responses in Patients With Pathogens Resistant to Ceftazidime at Test-of-cure (TOC) Visit in Microbiologically Modified Intent-to-treat Analysis Set at Test-of-cure Visit | Pseudomonas aeruginosa (n=11, 15) | 4 participants with favorable responses |
| Meropenem | The Number of Favorable Per-pathogen Microbiologic Responses in Patients With Pathogens Resistant to Ceftazidime at Test-of-cure (TOC) Visit in Microbiologically Modified Intent-to-treat Analysis Set at Test-of-cure Visit | Enterobacter aerogenes (n=4, 2) | 2 participants with favorable responses |
| Meropenem | The Number of Favorable Per-pathogen Microbiologic Responses in Patients With Pathogens Resistant to Ceftazidime at Test-of-cure (TOC) Visit in Microbiologically Modified Intent-to-treat Analysis Set at Test-of-cure Visit | Enterobacter cloacae (n=6, 6) | 5 participants with favorable responses |
| Meropenem | The Number of Favorable Per-pathogen Microbiologic Responses in Patients With Pathogens Resistant to Ceftazidime at Test-of-cure (TOC) Visit in Microbiologically Modified Intent-to-treat Analysis Set at Test-of-cure Visit | Escherichia coli (n=6, 5) | 4 participants with favorable responses |
| Meropenem | The Number of Favorable Per-pathogen Microbiologic Responses in Patients With Pathogens Resistant to Ceftazidime at Test-of-cure (TOC) Visit in Microbiologically Modified Intent-to-treat Analysis Set at Test-of-cure Visit | Klebsiella pneumoniae (n=20, 30) | 18 participants with favorable responses |
Secondary
The Number of Patients Discharged From Hospital up to Test-of-cure (TOC) Visit in Microbiologically Modified Intent-to-treat Analysis Set
The number of patients discharged from hospital in microbiologically modified intent-to-treat analysis set.
Time frame: up to 25 days from randomization
Population: The microbiological modified intent-to-treat (mMITT) analysis set included all patients who met the minimum disease criteria and received any amount of study treatment, and had at least one study-qualifying Gram-negative baseline pathogen.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CAZ-AVI | The Number of Patients Discharged From Hospital up to Test-of-cure (TOC) Visit in Microbiologically Modified Intent-to-treat Analysis Set | Number of patients with at least one discharge | 71 participants |
| CAZ-AVI | The Number of Patients Discharged From Hospital up to Test-of-cure (TOC) Visit in Microbiologically Modified Intent-to-treat Analysis Set | 2 discharges | 0 participants |
| CAZ-AVI | The Number of Patients Discharged From Hospital up to Test-of-cure (TOC) Visit in Microbiologically Modified Intent-to-treat Analysis Set | 1 discharge | 71 participants |
| CAZ-AVI | The Number of Patients Discharged From Hospital up to Test-of-cure (TOC) Visit in Microbiologically Modified Intent-to-treat Analysis Set | >2 discharges | 0 participants |
| CAZ-AVI | The Number of Patients Discharged From Hospital up to Test-of-cure (TOC) Visit in Microbiologically Modified Intent-to-treat Analysis Set | Number of patients with admission date | 170 participants |
| Meropenem | The Number of Patients Discharged From Hospital up to Test-of-cure (TOC) Visit in Microbiologically Modified Intent-to-treat Analysis Set | >2 discharges | 0 participants |
| Meropenem | The Number of Patients Discharged From Hospital up to Test-of-cure (TOC) Visit in Microbiologically Modified Intent-to-treat Analysis Set | Number of patients with admission date | 182 participants |
| Meropenem | The Number of Patients Discharged From Hospital up to Test-of-cure (TOC) Visit in Microbiologically Modified Intent-to-treat Analysis Set | Number of patients with at least one discharge | 75 participants |
| Meropenem | The Number of Patients Discharged From Hospital up to Test-of-cure (TOC) Visit in Microbiologically Modified Intent-to-treat Analysis Set | 1 discharge | 74 participants |
| Meropenem | The Number of Patients Discharged From Hospital up to Test-of-cure (TOC) Visit in Microbiologically Modified Intent-to-treat Analysis Set | 2 discharges | 1 participants |
Secondary
The Number of Patients Discharged From Hospital up to Test-of-cure (TOC) Visit in the Clinically Evaluable at Test-of-cure Analysis Set
The number of patients discharged from hospital in the clinically evaluable at test-of-cure analysis set.
Time frame: up to 25 days from randomization
Population: The clinically evaluable (CE) analysis set included all patients in the clinical modified intent-to-treat (cMITT) analysis set who met the stringent criteria for clinical evaluation described in the protocol regarding dosing, prior and concomitant medication, evaluation, etc.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CAZ-AVI | The Number of Patients Discharged From Hospital up to Test-of-cure (TOC) Visit in the Clinically Evaluable at Test-of-cure Analysis Set | Number of patients with at least one discharge | 148 participants |
| CAZ-AVI | The Number of Patients Discharged From Hospital up to Test-of-cure (TOC) Visit in the Clinically Evaluable at Test-of-cure Analysis Set | 1 discharge | 144 participants |
| CAZ-AVI | The Number of Patients Discharged From Hospital up to Test-of-cure (TOC) Visit in the Clinically Evaluable at Test-of-cure Analysis Set | 2 discharges | 4 participants |
| CAZ-AVI | The Number of Patients Discharged From Hospital up to Test-of-cure (TOC) Visit in the Clinically Evaluable at Test-of-cure Analysis Set | >2 discharges | 0 participants |
| CAZ-AVI | The Number of Patients Discharged From Hospital up to Test-of-cure (TOC) Visit in the Clinically Evaluable at Test-of-cure Analysis Set | Number of patients with admission date | 256 participants |
| Meropenem | The Number of Patients Discharged From Hospital up to Test-of-cure (TOC) Visit in the Clinically Evaluable at Test-of-cure Analysis Set | Number of patients with admission date | 266 participants |
| Meropenem | The Number of Patients Discharged From Hospital up to Test-of-cure (TOC) Visit in the Clinically Evaluable at Test-of-cure Analysis Set | >2 discharges | 1 participants |
| Meropenem | The Number of Patients Discharged From Hospital up to Test-of-cure (TOC) Visit in the Clinically Evaluable at Test-of-cure Analysis Set | 1 discharge | 151 participants |
| Meropenem | The Number of Patients Discharged From Hospital up to Test-of-cure (TOC) Visit in the Clinically Evaluable at Test-of-cure Analysis Set | Number of patients with at least one discharge | 155 participants |
| Meropenem | The Number of Patients Discharged From Hospital up to Test-of-cure (TOC) Visit in the Clinically Evaluable at Test-of-cure Analysis Set | 2 discharges | 3 participants |
Secondary
The Number of Patients Discharged From Hospital up to Test-of-cure (TOC) Visit in the Clinically Modified Intent-to-treat Analysis Set
The number of patients discharged from hospital in the clinically modified intent-to-treat analysis set.
Time frame: up to 25 days from randomization
Population: The clinical modified intent-to-treat (cMITT) included all patients who met the minimum disease criteria and received any amount of study treatment, and had either no baseline pathogens or at least one study-qualifying Gram-negative baseline pathogen.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CAZ-AVI | The Number of Patients Discharged From Hospital up to Test-of-cure (TOC) Visit in the Clinically Modified Intent-to-treat Analysis Set | Number of patients with at least one discharge | 206 participants |
| CAZ-AVI | The Number of Patients Discharged From Hospital up to Test-of-cure (TOC) Visit in the Clinically Modified Intent-to-treat Analysis Set | 1 discharge | 201 participants |
| CAZ-AVI | The Number of Patients Discharged From Hospital up to Test-of-cure (TOC) Visit in the Clinically Modified Intent-to-treat Analysis Set | 2 discharges | 5 participants |
| CAZ-AVI | The Number of Patients Discharged From Hospital up to Test-of-cure (TOC) Visit in the Clinically Modified Intent-to-treat Analysis Set | >2 discharges | 0 participants |
| CAZ-AVI | The Number of Patients Discharged From Hospital up to Test-of-cure (TOC) Visit in the Clinically Modified Intent-to-treat Analysis Set | Number of patients with admission date | 355 participants |
| Meropenem | The Number of Patients Discharged From Hospital up to Test-of-cure (TOC) Visit in the Clinically Modified Intent-to-treat Analysis Set | >2 discharges | 2 participants |
| Meropenem | The Number of Patients Discharged From Hospital up to Test-of-cure (TOC) Visit in the Clinically Modified Intent-to-treat Analysis Set | Number of patients with admission date | 366 participants |
| Meropenem | The Number of Patients Discharged From Hospital up to Test-of-cure (TOC) Visit in the Clinically Modified Intent-to-treat Analysis Set | Number of patients with at least one discharge | 206 participants |
| Meropenem | The Number of Patients Discharged From Hospital up to Test-of-cure (TOC) Visit in the Clinically Modified Intent-to-treat Analysis Set | 2 discharges | 4 participants |
| Meropenem | The Number of Patients Discharged From Hospital up to Test-of-cure (TOC) Visit in the Clinically Modified Intent-to-treat Analysis Set | 1 discharge | 200 participants |
Secondary
The Number of Patients With a Favorable Per-patient Microbiologic Response at End of Treatment (EOT) Visit in Extended Microbiologically Evaluable at End of Treatment Analysis Set
Per-patient favorable response indicates that all of the patient's baseline pathogens are eradicated or presumed eradicated. Eradication is defined as: source specimen demonstrates absence of the original baseline pathogen. Presumed eradication is defined as: source specimen was not available to culture and the patient was assessed as a clinical cure.
Time frame: Patients were followed after the last IV dose but no later than 24 hours after the last IV dose.
Population: The extended-ME (EME) analysis set defined as all patients in clinically evaluable (CE) analysis set with at least 1 etiologic pathogen from an adequate baseline culture regardless of susceptibility to study agents.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CAZ-AVI | The Number of Patients With a Favorable Per-patient Microbiologic Response at End of Treatment (EOT) Visit in Extended Microbiologically Evaluable at End of Treatment Analysis Set | Favorable | 112 participants |
| CAZ-AVI | The Number of Patients With a Favorable Per-patient Microbiologic Response at End of Treatment (EOT) Visit in Extended Microbiologically Evaluable at End of Treatment Analysis Set | Unfavorable | 31 participants |
| Meropenem | The Number of Patients With a Favorable Per-patient Microbiologic Response at End of Treatment (EOT) Visit in Extended Microbiologically Evaluable at End of Treatment Analysis Set | Favorable | 123 participants |
| Meropenem | The Number of Patients With a Favorable Per-patient Microbiologic Response at End of Treatment (EOT) Visit in Extended Microbiologically Evaluable at End of Treatment Analysis Set | Unfavorable | 28 participants |
Secondary
The Number of Patients With a Favorable Per-patient Microbiologic Response at End of Treatment (EOT) Visit in Microbiologically Evaluable at End of Treatment Analysis Set
Per-patient favorable response indicates that all of the patient's baseline pathogens are eradicated or presumed eradicated. Eradication is defined as: source specimen demonstrates absence of the original baseline pathogen. Presumed eradication is defined as: source specimen was not available to culture and the patient was assessed as a clinical cure.
Time frame: Patients were followed after the last IV dose but no later than 24 hours after the last IV dose.
Population: The microbiologically evaluable (ME) analysis sets defined as all patients in clinically evaluable (CE) analysis set with at least 1 etiologic pathogen from an adequate baseline culture that is susceptible to both study agents (CAZ-AVI and meropenem).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CAZ-AVI | The Number of Patients With a Favorable Per-patient Microbiologic Response at End of Treatment (EOT) Visit in Microbiologically Evaluable at End of Treatment Analysis Set | Favorable | 96 participants |
| CAZ-AVI | The Number of Patients With a Favorable Per-patient Microbiologic Response at End of Treatment (EOT) Visit in Microbiologically Evaluable at End of Treatment Analysis Set | Unfavorable | 26 participants |
| Meropenem | The Number of Patients With a Favorable Per-patient Microbiologic Response at End of Treatment (EOT) Visit in Microbiologically Evaluable at End of Treatment Analysis Set | Favorable | 112 participants |
| Meropenem | The Number of Patients With a Favorable Per-patient Microbiologic Response at End of Treatment (EOT) Visit in Microbiologically Evaluable at End of Treatment Analysis Set | Unfavorable | 26 participants |
Secondary
The Number of Patients With a Favorable Per-patient Microbiologic Response at End of Treatment (EOT) Visit in Microbiologically Modified Intent-to-treat Analysis Set
Per-patient favorable response indicates that all of the patient's baseline pathogens are eradicated or presumed eradicated. Eradication is defined as: source specimen demonstrates absence of the original baseline pathogen. Presumed eradication is defined as: source specimen was not available to culture and the patient was assessed as a clinical cure.
Time frame: Patients were followed after the last IV dose but no later than 24 hours after the last IV dose.
Population: The microbiological modified intent-to-treat (mMITT) analysis set included all patients who met the minimum disease criteria and received any amount of study treatment, and had at least one study-qualifying Gram-negative baseline pathogen.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CAZ-AVI | The Number of Patients With a Favorable Per-patient Microbiologic Response at End of Treatment (EOT) Visit in Microbiologically Modified Intent-to-treat Analysis Set | Favorable | 128 participants |
| CAZ-AVI | The Number of Patients With a Favorable Per-patient Microbiologic Response at End of Treatment (EOT) Visit in Microbiologically Modified Intent-to-treat Analysis Set | Unfavorable | 38 participants |
| CAZ-AVI | The Number of Patients With a Favorable Per-patient Microbiologic Response at End of Treatment (EOT) Visit in Microbiologically Modified Intent-to-treat Analysis Set | Indeterminate | 5 participants |
| Meropenem | The Number of Patients With a Favorable Per-patient Microbiologic Response at End of Treatment (EOT) Visit in Microbiologically Modified Intent-to-treat Analysis Set | Favorable | 148 participants |
| Meropenem | The Number of Patients With a Favorable Per-patient Microbiologic Response at End of Treatment (EOT) Visit in Microbiologically Modified Intent-to-treat Analysis Set | Unfavorable | 31 participants |
| Meropenem | The Number of Patients With a Favorable Per-patient Microbiologic Response at End of Treatment (EOT) Visit in Microbiologically Modified Intent-to-treat Analysis Set | Indeterminate | 5 participants |
Secondary
The Number of Patients With a Favorable Per-patient Microbiologic Response at Test-of-cure (TOC) Visit in Extended Microbiologically Evaluable at Test-of-cure Analysis Set
Per-patient favorable response indicates that all of the patient's baseline pathogens are eradicated or presumed eradicated. Eradication is defined as: source specimen demonstrates absence of the original baseline pathogen. Presumed eradication is defined as: source specimen was not available to culture and the patient was assessed as a clinical cure.
Time frame: At the test-of-cure (TOC) visit (Day 21 to 25)
Population: The extended-ME (EME) analysis set defined as all patients in clinically evaluable (CE) analysis set with at least 1 etiologic pathogen from an adequate baseline culture regardless of susceptibility to study agents.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CAZ-AVI | The Number of Patients With a Favorable Per-patient Microbiologic Response at Test-of-cure (TOC) Visit in Extended Microbiologically Evaluable at Test-of-cure Analysis Set | Favorable | 80 participants |
| CAZ-AVI | The Number of Patients With a Favorable Per-patient Microbiologic Response at Test-of-cure (TOC) Visit in Extended Microbiologically Evaluable at Test-of-cure Analysis Set | Unfavorable | 45 participants |
| Meropenem | The Number of Patients With a Favorable Per-patient Microbiologic Response at Test-of-cure (TOC) Visit in Extended Microbiologically Evaluable at Test-of-cure Analysis Set | Favorable | 89 participants |
| Meropenem | The Number of Patients With a Favorable Per-patient Microbiologic Response at Test-of-cure (TOC) Visit in Extended Microbiologically Evaluable at Test-of-cure Analysis Set | Unfavorable | 42 participants |
Secondary
The Number of Patients With a Favorable Per-patient Microbiologic Response at Test-of-cure (TOC) Visit in Microbiologically Evaluable at Test-of-cure Analysis Set
Per-patient favorable response indicates that all of the patient's baseline pathogens are eradicated or presumed eradicated. Eradication is defined as: source specimen demonstrates absence of the original baseline pathogen. Presumed eradication is defined as: source specimen was not available to culture and the patient was assessed as a clinical cure.
Time frame: At the test-of-cure (TOC) visit (Day 21 to 25)
Population: The microbiologically evaluable (ME) analysis sets defined as all patients in clinically evaluable (CE) analysis set with at least 1 etiologic pathogen from an adequate baseline culture that is susceptible to both study agents (CAZ-AVI and meropenem).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CAZ-AVI | The Number of Patients With a Favorable Per-patient Microbiologic Response at Test-of-cure (TOC) Visit in Microbiologically Evaluable at Test-of-cure Analysis Set | Favorable | 70 participants |
| CAZ-AVI | The Number of Patients With a Favorable Per-patient Microbiologic Response at Test-of-cure (TOC) Visit in Microbiologically Evaluable at Test-of-cure Analysis Set | Unfavorable | 37 participants |
| Meropenem | The Number of Patients With a Favorable Per-patient Microbiologic Response at Test-of-cure (TOC) Visit in Microbiologically Evaluable at Test-of-cure Analysis Set | Favorable | 83 participants |
| Meropenem | The Number of Patients With a Favorable Per-patient Microbiologic Response at Test-of-cure (TOC) Visit in Microbiologically Evaluable at Test-of-cure Analysis Set | Unfavorable | 35 participants |
Secondary
The Number of Patients With a Favorable Per-patient Microbiologic Response at Test-of-cure (TOC) Visit in Microbiologically Modified Intent-to-treat Analysis Set
Per-patient favorable response indicates that all of the patient's baseline pathogens are eradicated or presumed eradicated. Eradication is defined as: source specimen demonstrates absence of the original baseline pathogen. Presumed eradication is defined as: source specimen was not available to culture and the patient was assessed as a clinical cure.
Time frame: At the test-of-cure (TOC) visit (Day 21 to 25)
Population: The microbiological modified intent-to-treat (mMITT) analysis set included all patients who met the minimum disease criteria and received any amount of study treatment, and had at least one study-qualifying Gram-negative baseline pathogen.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CAZ-AVI | The Number of Patients With a Favorable Per-patient Microbiologic Response at Test-of-cure (TOC) Visit in Microbiologically Modified Intent-to-treat Analysis Set | Favorable | 95 participants |
| CAZ-AVI | The Number of Patients With a Favorable Per-patient Microbiologic Response at Test-of-cure (TOC) Visit in Microbiologically Modified Intent-to-treat Analysis Set | Unfavorable | 64 participants |
| CAZ-AVI | The Number of Patients With a Favorable Per-patient Microbiologic Response at Test-of-cure (TOC) Visit in Microbiologically Modified Intent-to-treat Analysis Set | Indeterminate | 12 participants |
| Meropenem | The Number of Patients With a Favorable Per-patient Microbiologic Response at Test-of-cure (TOC) Visit in Microbiologically Modified Intent-to-treat Analysis Set | Favorable | 118 participants |
| Meropenem | The Number of Patients With a Favorable Per-patient Microbiologic Response at Test-of-cure (TOC) Visit in Microbiologically Modified Intent-to-treat Analysis Set | Unfavorable | 54 participants |
| Meropenem | The Number of Patients With a Favorable Per-patient Microbiologic Response at Test-of-cure (TOC) Visit in Microbiologically Modified Intent-to-treat Analysis Set | Indeterminate | 12 participants |
Secondary
The Number of Patients With Clinical Cure at End of Treatment (EOT) Visit in Clinically Evaluable Analysis Set
The number of patients meeting the cure criteria: the patient is alive and all signs and symptoms of pneumonia have resolved or improved such that all antibacterial therapies for Nosocomial Pneumonia are stopped. No antibacterial therapy other than those outlined by the protocol has been administered for Nosocomial Pneumonia prior to end of treatment.
Time frame: Patients were followed after the last IV dose but no later than 24 hours after the last IV dose.
Population: The clinically evaluable (CE) analysis set included all patients in the clinical modified intent-to-treat (cMITT) analysis set who met the stringent criteria for clinical evaluation described in the protocol regarding dosing, prior and concomitant medication, evaluation, etc.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CAZ-AVI | The Number of Patients With Clinical Cure at End of Treatment (EOT) Visit in Clinically Evaluable Analysis Set | Clinical cure | 253 participants |
| CAZ-AVI | The Number of Patients With Clinical Cure at End of Treatment (EOT) Visit in Clinically Evaluable Analysis Set | Clinical failure | 38 participants |
| Meropenem | The Number of Patients With Clinical Cure at End of Treatment (EOT) Visit in Clinically Evaluable Analysis Set | Clinical cure | 268 participants |
| Meropenem | The Number of Patients With Clinical Cure at End of Treatment (EOT) Visit in Clinically Evaluable Analysis Set | Clinical failure | 38 participants |
Secondary
The Number of Patients With Clinical Cure at End of Treatment (EOT) Visit in Clinically Modified Intent-to-treat Analysis Set
The number of patients meeting the cure criteria: the patient is alive and all signs and symptoms of pneumonia have resolved or improved such that all antibacterial therapies for Nosocomial Pneumonia are stopped. No antibacterial therapy other than those outlined by the protocol has been administered for Nosocomial Pneumonia prior to end of treatment.
Time frame: Patients were followed after the last IV dose but no later than 24 hours after the last IV dose.
Population: The clinical modified intent-to-treat (cMITT) included all patients who met the minimum disease criteria and received any amount of study treatment, and had either no baseline pathogens or at least one study-qualifying Gram-negative baseline pathogen.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CAZ-AVI | The Number of Patients With Clinical Cure at End of Treatment (EOT) Visit in Clinically Modified Intent-to-treat Analysis Set | Clinical cure | 292 participants |
| CAZ-AVI | The Number of Patients With Clinical Cure at End of Treatment (EOT) Visit in Clinically Modified Intent-to-treat Analysis Set | Clinical failure | 50 participants |
| CAZ-AVI | The Number of Patients With Clinical Cure at End of Treatment (EOT) Visit in Clinically Modified Intent-to-treat Analysis Set | Indeterminate | 14 participants |
| Meropenem | The Number of Patients With Clinical Cure at End of Treatment (EOT) Visit in Clinically Modified Intent-to-treat Analysis Set | Clinical cure | 309 participants |
| Meropenem | The Number of Patients With Clinical Cure at End of Treatment (EOT) Visit in Clinically Modified Intent-to-treat Analysis Set | Clinical failure | 45 participants |
| Meropenem | The Number of Patients With Clinical Cure at End of Treatment (EOT) Visit in Clinically Modified Intent-to-treat Analysis Set | Indeterminate | 16 participants |
Secondary
The Number of Patients With Clinical Cure at End of Treatment (EOT) Visit in Extended Microbiologically Evaluable Analysis Set
The number of patients meeting the cure criteria: the patient is alive and all signs and symptoms of pneumonia have resolved or improved such that all antibacterial therapies for Nosocomial Pneumonia are stopped. No antibacterial therapy other than those outlined by the protocol has been administered for Nosocomial Pneumonia prior to end of treatment.
Time frame: Patients were followed after the last IV dose but no later than 24 hours after the last IV dose.
Population: The extended-ME (EME) analysis set defined as all patients in clinically evaluable (CE) analysis set with at least 1 etiologic pathogen from an adequate baseline culture regardless of susceptibility to study agents.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CAZ-AVI | The Number of Patients With Clinical Cure at End of Treatment (EOT) Visit in Extended Microbiologically Evaluable Analysis Set | Clinical cure | 125 participants |
| CAZ-AVI | The Number of Patients With Clinical Cure at End of Treatment (EOT) Visit in Extended Microbiologically Evaluable Analysis Set | Clinical failure | 18 participants |
| Meropenem | The Number of Patients With Clinical Cure at End of Treatment (EOT) Visit in Extended Microbiologically Evaluable Analysis Set | Clinical cure | 135 participants |
| Meropenem | The Number of Patients With Clinical Cure at End of Treatment (EOT) Visit in Extended Microbiologically Evaluable Analysis Set | Clinical failure | 16 participants |
Secondary
The Number of Patients With Clinical Cure at End of Treatment (EOT) Visit in Microbiologically Evaluable Analysis Set
The number of patients meeting the cure criteria: the patient is alive and all signs and symptoms of pneumonia have resolved or improved such that all antibacterial therapies for Nosocomial Pneumonia are stopped. No antibacterial therapy other than those outlined by the protocol has been administered for Nosocomial Pneumonia prior to end of treatment.
Time frame: Patients were followed after the last IV dose but no later than 24 hours after the last IV dose.
Population: The microbiologically evaluable (ME) analysis sets defined as all patients in clinically evaluable (CE) analysis set with at least 1 etiologic pathogen from an adequate baseline culture that is susceptible to both study agents (CAZ-AVI and meropenem).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CAZ-AVI | The Number of Patients With Clinical Cure at End of Treatment (EOT) Visit in Microbiologically Evaluable Analysis Set | Clinical cure | 110 participants |
| CAZ-AVI | The Number of Patients With Clinical Cure at End of Treatment (EOT) Visit in Microbiologically Evaluable Analysis Set | Clinical failure | 12 participants |
| Meropenem | The Number of Patients With Clinical Cure at End of Treatment (EOT) Visit in Microbiologically Evaluable Analysis Set | Clinical cure | 126 participants |
| Meropenem | The Number of Patients With Clinical Cure at End of Treatment (EOT) Visit in Microbiologically Evaluable Analysis Set | Clinical failure | 12 participants |
Secondary
The Number of Patients With Clinical Cure at End of Treatment (EOT) Visit in Microbiologically Modified Intent-to-treat Analysis Set
The number of patients meeting the cure criteria: the patient is alive and all signs and symptoms of pneumonia have resolved or improved such that all antibacterial therapies for Nosocomial Pneumonia are stopped. No antibacterial therapy other than those outlined by the protocol has been administered for Nosocomial Pneumonia prior to end of treatment.
Time frame: Patients were followed after the last IV dose but no later than 24 hours after the last IV dose.
Population: The microbiological modified intent-to-treat (mMITT) analysis set included all patients who met the minimum disease criteria and received any amount of study treatment, and had at least one study-qualifying Gram-negative baseline pathogen.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CAZ-AVI | The Number of Patients With Clinical Cure at End of Treatment (EOT) Visit in Microbiologically Modified Intent-to-treat Analysis Set | Clinical failure | 23 participants |
| CAZ-AVI | The Number of Patients With Clinical Cure at End of Treatment (EOT) Visit in Microbiologically Modified Intent-to-treat Analysis Set | Indeterminate | 5 participants |
| CAZ-AVI | The Number of Patients With Clinical Cure at End of Treatment (EOT) Visit in Microbiologically Modified Intent-to-treat Analysis Set | Clinical cure | 143 participants |
| Meropenem | The Number of Patients With Clinical Cure at End of Treatment (EOT) Visit in Microbiologically Modified Intent-to-treat Analysis Set | Clinical cure | 161 participants |
| Meropenem | The Number of Patients With Clinical Cure at End of Treatment (EOT) Visit in Microbiologically Modified Intent-to-treat Analysis Set | Clinical failure | 18 participants |
| Meropenem | The Number of Patients With Clinical Cure at End of Treatment (EOT) Visit in Microbiologically Modified Intent-to-treat Analysis Set | Indeterminate | 5 participants |
Secondary
The Number of Patients With Clinical Cure at Test-of-cure (TOC) Visit in the Extended Microbiologically Evaluable Analysis Set
The number of patients meeting the cure criteria: the patient was not a clinical failure at end of treatment and the patient is alive and all signs and symptoms of pneumonia have resolved or improved to an extent that no antibacterial therapy for Nosocomial Pneumonia was taken between end of treatment and test-of-cure inclusive.
Time frame: At the test-of-cure (TOC) visit (Day 21 to 25)
Population: The extended-ME (EME) analysis set defined as all patients in clinically evaluable (CE) analysis set with at least 1 etiologic pathogen from an adequate baseline culture regardless of susceptibility to study agents.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CAZ-AVI | The Number of Patients With Clinical Cure at Test-of-cure (TOC) Visit in the Extended Microbiologically Evaluable Analysis Set | Clinical cure | 96 participants |
| CAZ-AVI | The Number of Patients With Clinical Cure at Test-of-cure (TOC) Visit in the Extended Microbiologically Evaluable Analysis Set | Clinical failure | 29 participants |
| Meropenem | The Number of Patients With Clinical Cure at Test-of-cure (TOC) Visit in the Extended Microbiologically Evaluable Analysis Set | Clinical cure | 103 participants |
| Meropenem | The Number of Patients With Clinical Cure at Test-of-cure (TOC) Visit in the Extended Microbiologically Evaluable Analysis Set | Clinical failure | 28 participants |
Secondary
The Number of Patients With Clinical Cure at Test-of-cure (TOC) Visit in the Microbiologically Evaluable Analysis Set
The number of patients meeting the cure criteria: the patient was not a clinical failure at end of treatment and the patient is alive and all signs and symptoms of pneumonia have resolved or improved to an extent that no antibacterial therapy for Nosocomial Pneumonia was taken between end of treatment and test-of-cure inclusive.
Time frame: At the test-of-cure (TOC) visit (Day 21 to 25)
Population: The microbiologically evaluable (ME) analysis sets defined as all patients in clinically evaluable (CE) analysis set with at least 1 etiologic pathogen from an adequate baseline culture that is susceptible to both study agents (CAZ-AVI and meropenem).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CAZ-AVI | The Number of Patients With Clinical Cure at Test-of-cure (TOC) Visit in the Microbiologically Evaluable Analysis Set | Clinical cure | 85 participants |
| CAZ-AVI | The Number of Patients With Clinical Cure at Test-of-cure (TOC) Visit in the Microbiologically Evaluable Analysis Set | Clinical failure | 22 participants |
| Meropenem | The Number of Patients With Clinical Cure at Test-of-cure (TOC) Visit in the Microbiologically Evaluable Analysis Set | Clinical failure | 24 participants |
| Meropenem | The Number of Patients With Clinical Cure at Test-of-cure (TOC) Visit in the Microbiologically Evaluable Analysis Set | Clinical cure | 94 participants |
Secondary
The Number of Patients With Clinical Cure at Test-of-cure (TOC) Visit in the Microbiologically Modified Intent-to-treat Analysis Set
The number of patients meeting the cure criteria: the patient was not a clinical failure at end of treatment and the patient is alive and all signs and symptoms of pneumonia have resolved or improved to an extent that no antibacterial therapy for Nosocomial Pneumonia was taken between end of treatment and test-of-cure inclusive.
Time frame: At the test-of-cure (TOC) visit (Day 21 to 25)
Population: The microbiological modified intent-to-treat (mMITT) analysis set included all patients who met the minimum disease criteria and received any amount of study treatment, and had at least one study-qualifying Gram-negative baseline pathogen.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CAZ-AVI | The Number of Patients With Clinical Cure at Test-of-cure (TOC) Visit in the Microbiologically Modified Intent-to-treat Analysis Set | Indeterminate | 14 participants |
| CAZ-AVI | The Number of Patients With Clinical Cure at Test-of-cure (TOC) Visit in the Microbiologically Modified Intent-to-treat Analysis Set | Clinical cure | 120 participants |
| CAZ-AVI | The Number of Patients With Clinical Cure at Test-of-cure (TOC) Visit in the Microbiologically Modified Intent-to-treat Analysis Set | Clinical failure | 37 participants |
| Meropenem | The Number of Patients With Clinical Cure at Test-of-cure (TOC) Visit in the Microbiologically Modified Intent-to-treat Analysis Set | Clinical failure | 34 participants |
| Meropenem | The Number of Patients With Clinical Cure at Test-of-cure (TOC) Visit in the Microbiologically Modified Intent-to-treat Analysis Set | Clinical cure | 138 participants |
| Meropenem | The Number of Patients With Clinical Cure at Test-of-cure (TOC) Visit in the Microbiologically Modified Intent-to-treat Analysis Set | Indeterminate | 12 participants |
Secondary
The Number of Patients With Clinical Cure in Patients With Pathogens Resistant to Ceftazidime at End of Treatment (EOT) Visit in Clinically Evaluable at End of Treatment Analysis Set
The number of patients meeting the cure criteria: the patient is alive and all signs and symptoms of pneumonia have resolved or improved such that all antibacterial therapies for Nosocomial Pneumonia are stopped. No antibacterial therapy other than those outlined by the protocol has been administered for Nosocomial Pneumonia prior to end of treatment.
Time frame: Patients were followed after the last IV dose but no later than 24 hours after the last IV dose.
Population: The clinically evaluable (CE) analysis set included all patients in the clinical modified intent-to-treat (cMITT) analysis set who met the stringent criteria for clinical evaluation described in the protocol regarding dosing, prior and concomitant medication, evaluation, etc. (pathogens in ≥5 patients)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CAZ-AVI | The Number of Patients With Clinical Cure in Patients With Pathogens Resistant to Ceftazidime at End of Treatment (EOT) Visit in Clinically Evaluable at End of Treatment Analysis Set | Pseudomonas aeruginosa (n=10, 13) | 8 participants |
| CAZ-AVI | The Number of Patients With Clinical Cure in Patients With Pathogens Resistant to Ceftazidime at End of Treatment (EOT) Visit in Clinically Evaluable at End of Treatment Analysis Set | Enterobacteriaceae (n=29, 37) | 27 participants |
| CAZ-AVI | The Number of Patients With Clinical Cure in Patients With Pathogens Resistant to Ceftazidime at End of Treatment (EOT) Visit in Clinically Evaluable at End of Treatment Analysis Set | Enterobacter aerogenes (n=4, 2) | 3 participants |
| CAZ-AVI | The Number of Patients With Clinical Cure in Patients With Pathogens Resistant to Ceftazidime at End of Treatment (EOT) Visit in Clinically Evaluable at End of Treatment Analysis Set | Enterobacter cloacae (n=6, 5) | 6 participants |
| CAZ-AVI | The Number of Patients With Clinical Cure in Patients With Pathogens Resistant to Ceftazidime at End of Treatment (EOT) Visit in Clinically Evaluable at End of Treatment Analysis Set | Escherichia coli (n=6, 4) | 5 participants |
| CAZ-AVI | The Number of Patients With Clinical Cure in Patients With Pathogens Resistant to Ceftazidime at End of Treatment (EOT) Visit in Clinically Evaluable at End of Treatment Analysis Set | Klebsiella pneumoniae (n=16, 28) | 16 participants |
| CAZ-AVI | The Number of Patients With Clinical Cure in Patients With Pathogens Resistant to Ceftazidime at End of Treatment (EOT) Visit in Clinically Evaluable at End of Treatment Analysis Set | Gram- pathogens not Enterobacteriaceae (n=10,14) | 8 participants |
| CAZ-AVI | The Number of Patients With Clinical Cure in Patients With Pathogens Resistant to Ceftazidime at End of Treatment (EOT) Visit in Clinically Evaluable at End of Treatment Analysis Set | All (n=39, 49) | 35 participants |
| Meropenem | The Number of Patients With Clinical Cure in Patients With Pathogens Resistant to Ceftazidime at End of Treatment (EOT) Visit in Clinically Evaluable at End of Treatment Analysis Set | Gram- pathogens not Enterobacteriaceae (n=10,14) | 13 participants |
| Meropenem | The Number of Patients With Clinical Cure in Patients With Pathogens Resistant to Ceftazidime at End of Treatment (EOT) Visit in Clinically Evaluable at End of Treatment Analysis Set | Enterobacter cloacae (n=6, 5) | 3 participants |
| Meropenem | The Number of Patients With Clinical Cure in Patients With Pathogens Resistant to Ceftazidime at End of Treatment (EOT) Visit in Clinically Evaluable at End of Treatment Analysis Set | Escherichia coli (n=6, 4) | 3 participants |
| Meropenem | The Number of Patients With Clinical Cure in Patients With Pathogens Resistant to Ceftazidime at End of Treatment (EOT) Visit in Clinically Evaluable at End of Treatment Analysis Set | Pseudomonas aeruginosa (n=10, 13) | 12 participants |
| Meropenem | The Number of Patients With Clinical Cure in Patients With Pathogens Resistant to Ceftazidime at End of Treatment (EOT) Visit in Clinically Evaluable at End of Treatment Analysis Set | All (n=39, 49) | 42 participants |
| Meropenem | The Number of Patients With Clinical Cure in Patients With Pathogens Resistant to Ceftazidime at End of Treatment (EOT) Visit in Clinically Evaluable at End of Treatment Analysis Set | Enterobacteriaceae (n=29, 37) | 31 participants |
| Meropenem | The Number of Patients With Clinical Cure in Patients With Pathogens Resistant to Ceftazidime at End of Treatment (EOT) Visit in Clinically Evaluable at End of Treatment Analysis Set | Klebsiella pneumoniae (n=16, 28) | 25 participants |
| Meropenem | The Number of Patients With Clinical Cure in Patients With Pathogens Resistant to Ceftazidime at End of Treatment (EOT) Visit in Clinically Evaluable at End of Treatment Analysis Set | Enterobacter aerogenes (n=4, 2) | 2 participants |
Secondary
The Number of Patients With Clinical Cure in Patients With Pathogens Resistant to Ceftazidime at End of Treatment (EOT) Visit in Clinically Modified Intent-to-treat Analysis Set at End of Treatment Visit
The number of patients meeting the cure criteria: the patient is alive and all signs and symptoms of pneumonia have resolved or improved such that all antibacterial therapies for Nosocomial Pneumonia are stopped. No antibacterial therapy other than those outlined by the protocol has been administered for Nosocomial Pneumonia prior to end of treatment.
Time frame: Patients were followed after the last IV dose but no later than 24 hours after the last IV dose.
Population: The microbiological modified intent-to-treat (mMITT) analysis set included all patients who met the minimum disease criteria and received any amount of study treatment, and had at least one study-qualifying Gram-negative baseline pathogen. (pathogens in ≥5 patients)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CAZ-AVI | The Number of Patients With Clinical Cure in Patients With Pathogens Resistant to Ceftazidime at End of Treatment (EOT) Visit in Clinically Modified Intent-to-treat Analysis Set at End of Treatment Visit | Enterobacter cloacae (n=6, 6) | 6 participants |
| CAZ-AVI | The Number of Patients With Clinical Cure in Patients With Pathogens Resistant to Ceftazidime at End of Treatment (EOT) Visit in Clinically Modified Intent-to-treat Analysis Set at End of Treatment Visit | Pseudomonas aeruginosa (n=11, 15) | 8 participants |
| CAZ-AVI | The Number of Patients With Clinical Cure in Patients With Pathogens Resistant to Ceftazidime at End of Treatment (EOT) Visit in Clinically Modified Intent-to-treat Analysis Set at End of Treatment Visit | Enterobacteriaceae (n=34, 41) | 32 participants |
| CAZ-AVI | The Number of Patients With Clinical Cure in Patients With Pathogens Resistant to Ceftazidime at End of Treatment (EOT) Visit in Clinically Modified Intent-to-treat Analysis Set at End of Treatment Visit | Enterobacter aerogenes (n=4, 2) | 3 participants |
| CAZ-AVI | The Number of Patients With Clinical Cure in Patients With Pathogens Resistant to Ceftazidime at End of Treatment (EOT) Visit in Clinically Modified Intent-to-treat Analysis Set at End of Treatment Visit | Escherichia coli (n=6, 5) | 5 participants |
| CAZ-AVI | The Number of Patients With Clinical Cure in Patients With Pathogens Resistant to Ceftazidime at End of Treatment (EOT) Visit in Clinically Modified Intent-to-treat Analysis Set at End of Treatment Visit | Gram- pathogens not Enterobacteriaceae (n=11,16) | 8 participants |
| CAZ-AVI | The Number of Patients With Clinical Cure in Patients With Pathogens Resistant to Ceftazidime at End of Treatment (EOT) Visit in Clinically Modified Intent-to-treat Analysis Set at End of Treatment Visit | Klebsiella pneumoniae (n=20, 30) | 20 participants |
| CAZ-AVI | The Number of Patients With Clinical Cure in Patients With Pathogens Resistant to Ceftazidime at End of Treatment (EOT) Visit in Clinically Modified Intent-to-treat Analysis Set at End of Treatment Visit | All (n=45, 54) | 40 participants |
| Meropenem | The Number of Patients With Clinical Cure in Patients With Pathogens Resistant to Ceftazidime at End of Treatment (EOT) Visit in Clinically Modified Intent-to-treat Analysis Set at End of Treatment Visit | Klebsiella pneumoniae (n=20, 30) | 26 participants |
| Meropenem | The Number of Patients With Clinical Cure in Patients With Pathogens Resistant to Ceftazidime at End of Treatment (EOT) Visit in Clinically Modified Intent-to-treat Analysis Set at End of Treatment Visit | All (n=45, 54) | 45 participants |
| Meropenem | The Number of Patients With Clinical Cure in Patients With Pathogens Resistant to Ceftazidime at End of Treatment (EOT) Visit in Clinically Modified Intent-to-treat Analysis Set at End of Treatment Visit | Enterobacteriaceae (n=34, 41) | 33 participants |
| Meropenem | The Number of Patients With Clinical Cure in Patients With Pathogens Resistant to Ceftazidime at End of Treatment (EOT) Visit in Clinically Modified Intent-to-treat Analysis Set at End of Treatment Visit | Enterobacter aerogenes (n=4, 2) | 2 participants |
| Meropenem | The Number of Patients With Clinical Cure in Patients With Pathogens Resistant to Ceftazidime at End of Treatment (EOT) Visit in Clinically Modified Intent-to-treat Analysis Set at End of Treatment Visit | Enterobacter cloacae (n=6, 6) | 4 participants |
| Meropenem | The Number of Patients With Clinical Cure in Patients With Pathogens Resistant to Ceftazidime at End of Treatment (EOT) Visit in Clinically Modified Intent-to-treat Analysis Set at End of Treatment Visit | Gram- pathogens not Enterobacteriaceae (n=11,16) | 14 participants |
| Meropenem | The Number of Patients With Clinical Cure in Patients With Pathogens Resistant to Ceftazidime at End of Treatment (EOT) Visit in Clinically Modified Intent-to-treat Analysis Set at End of Treatment Visit | Pseudomonas aeruginosa (n=11, 15) | 13 participants |
| Meropenem | The Number of Patients With Clinical Cure in Patients With Pathogens Resistant to Ceftazidime at End of Treatment (EOT) Visit in Clinically Modified Intent-to-treat Analysis Set at End of Treatment Visit | Escherichia coli (n=6, 5) | 3 participants |
Secondary
The Number of Patients With Clinical Cure in Patients With Pathogens Resistant to Ceftazidime at End of Treatment (EOT) Visit in Microbiologically Evaluable at End of Treatment Analysis Set
The number of patients meeting the cure criteria: the patient is alive and all signs and symptoms of pneumonia have resolved or improved such that all antibacterial therapies for Nosocomial Pneumonia are stopped. No antibacterial therapy other than those outlined by the protocol has been administered for Nosocomial Pneumonia prior to end of treatment.
Time frame: Patients were followed after the last IV dose but no later than 24 hours after the last IV dose.
Population: The microbiologically evaluable (ME) analysis sets defined as all patients in clinically evaluable (CE) analysis set with at least 1 etiologic pathogen from an adequate baseline culture that is susceptible to both study agents (CAZ-AVI and meropenem). (pathogens in ≥5 patients)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CAZ-AVI | The Number of Patients With Clinical Cure in Patients With Pathogens Resistant to Ceftazidime at End of Treatment (EOT) Visit in Microbiologically Evaluable at End of Treatment Analysis Set | Enterobacter cloacae (n=6, 5) | 6 participants |
| CAZ-AVI | The Number of Patients With Clinical Cure in Patients With Pathogens Resistant to Ceftazidime at End of Treatment (EOT) Visit in Microbiologically Evaluable at End of Treatment Analysis Set | Enterobacteriaceae (n=28, 35) | 27 participants |
| CAZ-AVI | The Number of Patients With Clinical Cure in Patients With Pathogens Resistant to Ceftazidime at End of Treatment (EOT) Visit in Microbiologically Evaluable at End of Treatment Analysis Set | Escherichia coli (n=5, 4) | 5 participants |
| CAZ-AVI | The Number of Patients With Clinical Cure in Patients With Pathogens Resistant to Ceftazidime at End of Treatment (EOT) Visit in Microbiologically Evaluable at End of Treatment Analysis Set | Pseudomonas aeruginosa (n=4, 6) | 4 participants |
| CAZ-AVI | The Number of Patients With Clinical Cure in Patients With Pathogens Resistant to Ceftazidime at End of Treatment (EOT) Visit in Microbiologically Evaluable at End of Treatment Analysis Set | Klebsiella pneumoniae (n=16, 26) | 16 participants |
| CAZ-AVI | The Number of Patients With Clinical Cure in Patients With Pathogens Resistant to Ceftazidime at End of Treatment (EOT) Visit in Microbiologically Evaluable at End of Treatment Analysis Set | Enterobacter aerogenes (n=4, 2) | 3 participants |
| CAZ-AVI | The Number of Patients With Clinical Cure in Patients With Pathogens Resistant to Ceftazidime at End of Treatment (EOT) Visit in Microbiologically Evaluable at End of Treatment Analysis Set | Gram- pathogens not Enterobacteriaceae (n=4,7) | 4 participants |
| CAZ-AVI | The Number of Patients With Clinical Cure in Patients With Pathogens Resistant to Ceftazidime at End of Treatment (EOT) Visit in Microbiologically Evaluable at End of Treatment Analysis Set | All (n=32, 40) | 31 participants |
| Meropenem | The Number of Patients With Clinical Cure in Patients With Pathogens Resistant to Ceftazidime at End of Treatment (EOT) Visit in Microbiologically Evaluable at End of Treatment Analysis Set | Pseudomonas aeruginosa (n=4, 6) | 6 participants |
| Meropenem | The Number of Patients With Clinical Cure in Patients With Pathogens Resistant to Ceftazidime at End of Treatment (EOT) Visit in Microbiologically Evaluable at End of Treatment Analysis Set | Gram- pathogens not Enterobacteriaceae (n=4,7) | 7 participants |
| Meropenem | The Number of Patients With Clinical Cure in Patients With Pathogens Resistant to Ceftazidime at End of Treatment (EOT) Visit in Microbiologically Evaluable at End of Treatment Analysis Set | All (n=32, 40) | 36 participants |
| Meropenem | The Number of Patients With Clinical Cure in Patients With Pathogens Resistant to Ceftazidime at End of Treatment (EOT) Visit in Microbiologically Evaluable at End of Treatment Analysis Set | Enterobacteriaceae (n=28, 35) | 31 participants |
| Meropenem | The Number of Patients With Clinical Cure in Patients With Pathogens Resistant to Ceftazidime at End of Treatment (EOT) Visit in Microbiologically Evaluable at End of Treatment Analysis Set | Enterobacter aerogenes (n=4, 2) | 2 participants |
| Meropenem | The Number of Patients With Clinical Cure in Patients With Pathogens Resistant to Ceftazidime at End of Treatment (EOT) Visit in Microbiologically Evaluable at End of Treatment Analysis Set | Enterobacter cloacae (n=6, 5) | 3 participants |
| Meropenem | The Number of Patients With Clinical Cure in Patients With Pathogens Resistant to Ceftazidime at End of Treatment (EOT) Visit in Microbiologically Evaluable at End of Treatment Analysis Set | Escherichia coli (n=5, 4) | 3 participants |
| Meropenem | The Number of Patients With Clinical Cure in Patients With Pathogens Resistant to Ceftazidime at End of Treatment (EOT) Visit in Microbiologically Evaluable at End of Treatment Analysis Set | Klebsiella pneumoniae (n=16, 26) | 25 participants |
Secondary
The Number of Patients With Clinical Cure in Patients With Pathogens Resistant to Ceftazidime at Test-of-cure (TOC) Visit in Clinically Evaluable at Test-of-cure Analysis Set
The number of patients meeting the cure criteria: the patient was not a clinical failure at end of treatment and the patient is alive and all signs and symptoms of pneumonia have resolved or improved to an extent that no antibacterial therapy for Nosocomial Pneumonia was taken between end of treatment and test-of-cure inclusive.
Time frame: At the test-of-cure (TOC) visit (Day 21 to 25)
Population: The clinically evaluable (CE) analysis set included all patients in the clinical modified intent-to-treat (cMITT) analysis set who met the stringent criteria for clinical evaluation described in the protocol regarding dosing, prior and concomitant medication, evaluation, etc. (pathogens in ≥5 patients)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CAZ-AVI | The Number of Patients With Clinical Cure in Patients With Pathogens Resistant to Ceftazidime at Test-of-cure (TOC) Visit in Clinically Evaluable at Test-of-cure Analysis Set | All (n=36, 41) | 29 participants |
| CAZ-AVI | The Number of Patients With Clinical Cure in Patients With Pathogens Resistant to Ceftazidime at Test-of-cure (TOC) Visit in Clinically Evaluable at Test-of-cure Analysis Set | Klebsiella pneumoniae (n=14, 22) | 12 participants |
| CAZ-AVI | The Number of Patients With Clinical Cure in Patients With Pathogens Resistant to Ceftazidime at Test-of-cure (TOC) Visit in Clinically Evaluable at Test-of-cure Analysis Set | Enterobacter cloacae (n=5, 5) | 5 participants |
| CAZ-AVI | The Number of Patients With Clinical Cure in Patients With Pathogens Resistant to Ceftazidime at Test-of-cure (TOC) Visit in Clinically Evaluable at Test-of-cure Analysis Set | Gram- pathogens not Enterobacteriaceae (n=9,13) | 6 participants |
| CAZ-AVI | The Number of Patients With Clinical Cure in Patients With Pathogens Resistant to Ceftazidime at Test-of-cure (TOC) Visit in Clinically Evaluable at Test-of-cure Analysis Set | Enterobacteriaceae (n=27, 30) | 23 participants |
| CAZ-AVI | The Number of Patients With Clinical Cure in Patients With Pathogens Resistant to Ceftazidime at Test-of-cure (TOC) Visit in Clinically Evaluable at Test-of-cure Analysis Set | Pseudomonas aeruginosa (n=9, 13) | 6 participants |
| CAZ-AVI | The Number of Patients With Clinical Cure in Patients With Pathogens Resistant to Ceftazidime at Test-of-cure (TOC) Visit in Clinically Evaluable at Test-of-cure Analysis Set | Escherichia coli (n=5, 4) | 4 participants |
| Meropenem | The Number of Patients With Clinical Cure in Patients With Pathogens Resistant to Ceftazidime at Test-of-cure (TOC) Visit in Clinically Evaluable at Test-of-cure Analysis Set | Pseudomonas aeruginosa (n=9, 13) | 12 participants |
| Meropenem | The Number of Patients With Clinical Cure in Patients With Pathogens Resistant to Ceftazidime at Test-of-cure (TOC) Visit in Clinically Evaluable at Test-of-cure Analysis Set | All (n=36, 41) | 32 participants |
| Meropenem | The Number of Patients With Clinical Cure in Patients With Pathogens Resistant to Ceftazidime at Test-of-cure (TOC) Visit in Clinically Evaluable at Test-of-cure Analysis Set | Enterobacteriaceae (n=27, 30) | 22 participants |
| Meropenem | The Number of Patients With Clinical Cure in Patients With Pathogens Resistant to Ceftazidime at Test-of-cure (TOC) Visit in Clinically Evaluable at Test-of-cure Analysis Set | Enterobacter cloacae (n=5, 5) | 3 participants |
| Meropenem | The Number of Patients With Clinical Cure in Patients With Pathogens Resistant to Ceftazidime at Test-of-cure (TOC) Visit in Clinically Evaluable at Test-of-cure Analysis Set | Escherichia coli (n=5, 4) | 3 participants |
| Meropenem | The Number of Patients With Clinical Cure in Patients With Pathogens Resistant to Ceftazidime at Test-of-cure (TOC) Visit in Clinically Evaluable at Test-of-cure Analysis Set | Klebsiella pneumoniae (n=14, 22) | 17 participants |
| Meropenem | The Number of Patients With Clinical Cure in Patients With Pathogens Resistant to Ceftazidime at Test-of-cure (TOC) Visit in Clinically Evaluable at Test-of-cure Analysis Set | Gram- pathogens not Enterobacteriaceae (n=9,13) | 12 participants |
Secondary
The Number of Patients With Clinical Cure in Patients With Pathogens Resistant to Ceftazidime at Test-of-cure (TOC) Visit in Clinically Modified Intent-to-treat Analysis Set at Test-of-cure Visit
The number of patients meeting the cure criteria: the patient was not a clinical failure at end of treatment and the patient is alive and all signs and symptoms of pneumonia have resolved or improved to an extent that no antibacterial therapy for Nosocomial Pneumonia was taken between end of treatment and test-of-cure inclusive.
Time frame: At the test-of-cure (TOC) visit (Day 21 to 25)
Population: The microbiological modified intent-to-treat (mMITT) analysis set included all patients who met the minimum disease criteria and received any amount of study treatment, and had at least one study-qualifying Gram-negative baseline pathogen. (pathogens in ≥5 patients)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CAZ-AVI | The Number of Patients With Clinical Cure in Patients With Pathogens Resistant to Ceftazidime at Test-of-cure (TOC) Visit in Clinically Modified Intent-to-treat Analysis Set at Test-of-cure Visit | Enterobacter aerogenes (n=4, 2) | 3 participants |
| CAZ-AVI | The Number of Patients With Clinical Cure in Patients With Pathogens Resistant to Ceftazidime at Test-of-cure (TOC) Visit in Clinically Modified Intent-to-treat Analysis Set at Test-of-cure Visit | All (n=45, 54) | 35 participants |
| CAZ-AVI | The Number of Patients With Clinical Cure in Patients With Pathogens Resistant to Ceftazidime at Test-of-cure (TOC) Visit in Clinically Modified Intent-to-treat Analysis Set at Test-of-cure Visit | Enterobacteriaceae (n=34, 41) | 28 participants |
| CAZ-AVI | The Number of Patients With Clinical Cure in Patients With Pathogens Resistant to Ceftazidime at Test-of-cure (TOC) Visit in Clinically Modified Intent-to-treat Analysis Set at Test-of-cure Visit | Enterobacter cloacae (n=6, 6) | 6 participants |
| CAZ-AVI | The Number of Patients With Clinical Cure in Patients With Pathogens Resistant to Ceftazidime at Test-of-cure (TOC) Visit in Clinically Modified Intent-to-treat Analysis Set at Test-of-cure Visit | Escherichia coli (n=6, 5) | 4 participants |
| CAZ-AVI | The Number of Patients With Clinical Cure in Patients With Pathogens Resistant to Ceftazidime at Test-of-cure (TOC) Visit in Clinically Modified Intent-to-treat Analysis Set at Test-of-cure Visit | Klebsiella pneumoniae (n=20, 30) | 16 participants |
| CAZ-AVI | The Number of Patients With Clinical Cure in Patients With Pathogens Resistant to Ceftazidime at Test-of-cure (TOC) Visit in Clinically Modified Intent-to-treat Analysis Set at Test-of-cure Visit | Gram- pathogens not Enterobacteriaceae (n=11,16) | 7 participants |
| CAZ-AVI | The Number of Patients With Clinical Cure in Patients With Pathogens Resistant to Ceftazidime at Test-of-cure (TOC) Visit in Clinically Modified Intent-to-treat Analysis Set at Test-of-cure Visit | Pseudomonas aeruginosa (n=11, 15) | 7 participants |
| Meropenem | The Number of Patients With Clinical Cure in Patients With Pathogens Resistant to Ceftazidime at Test-of-cure (TOC) Visit in Clinically Modified Intent-to-treat Analysis Set at Test-of-cure Visit | Pseudomonas aeruginosa (n=11, 15) | 13 participants |
| Meropenem | The Number of Patients With Clinical Cure in Patients With Pathogens Resistant to Ceftazidime at Test-of-cure (TOC) Visit in Clinically Modified Intent-to-treat Analysis Set at Test-of-cure Visit | Escherichia coli (n=6, 5) | 3 participants |
| Meropenem | The Number of Patients With Clinical Cure in Patients With Pathogens Resistant to Ceftazidime at Test-of-cure (TOC) Visit in Clinically Modified Intent-to-treat Analysis Set at Test-of-cure Visit | All (n=45, 54) | 40 participants |
| Meropenem | The Number of Patients With Clinical Cure in Patients With Pathogens Resistant to Ceftazidime at Test-of-cure (TOC) Visit in Clinically Modified Intent-to-treat Analysis Set at Test-of-cure Visit | Gram- pathogens not Enterobacteriaceae (n=11,16) | 13 participants |
| Meropenem | The Number of Patients With Clinical Cure in Patients With Pathogens Resistant to Ceftazidime at Test-of-cure (TOC) Visit in Clinically Modified Intent-to-treat Analysis Set at Test-of-cure Visit | Enterobacteriaceae (n=34, 41) | 29 participants |
| Meropenem | The Number of Patients With Clinical Cure in Patients With Pathogens Resistant to Ceftazidime at Test-of-cure (TOC) Visit in Clinically Modified Intent-to-treat Analysis Set at Test-of-cure Visit | Enterobacter aerogenes (n=4, 2) | 2 participants |
| Meropenem | The Number of Patients With Clinical Cure in Patients With Pathogens Resistant to Ceftazidime at Test-of-cure (TOC) Visit in Clinically Modified Intent-to-treat Analysis Set at Test-of-cure Visit | Klebsiella pneumoniae (n=20, 30) | 22 participants |
| Meropenem | The Number of Patients With Clinical Cure in Patients With Pathogens Resistant to Ceftazidime at Test-of-cure (TOC) Visit in Clinically Modified Intent-to-treat Analysis Set at Test-of-cure Visit | Enterobacter cloacae (n=6, 6) | 4 participants |
Secondary
The Number of Patients With Clinical Cure in Patients With Pathogens Resistant to Ceftazidime at Test-of-cure (TOC) Visit in Microbiologically Evaluable at Test-of-cure Analysis Set
The number of patients meeting the cure criteria: the patient was not a clinical failure at end of treatment and the patient is alive and all signs and symptoms of pneumonia have resolved or improved to an extent that no antibacterial therapy for Nosocomial Pneumonia was taken between end of treatment and test-of-cure inclusive.
Time frame: At the test-of-cure (TOC) visit (Day 21 to 25)
Population: The microbiologically evaluable (ME) analysis sets defined as all patients in clinically evaluable (CE) analysis set with at least 1 etiologic pathogen from an adequate baseline culture that is susceptible to both study agents (CAZ-AVI and meropenem). (pathogens in ≥5 patients)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CAZ-AVI | The Number of Patients With Clinical Cure in Patients With Pathogens Resistant to Ceftazidime at Test-of-cure (TOC) Visit in Microbiologically Evaluable at Test-of-cure Analysis Set | Gram- pathogens not Enterobacteriaceae (n=3,6) | 2 participants |
| CAZ-AVI | The Number of Patients With Clinical Cure in Patients With Pathogens Resistant to Ceftazidime at Test-of-cure (TOC) Visit in Microbiologically Evaluable at Test-of-cure Analysis Set | Pseudomonas aeruginosa (n=3, 6) | 2 participants |
| CAZ-AVI | The Number of Patients With Clinical Cure in Patients With Pathogens Resistant to Ceftazidime at Test-of-cure (TOC) Visit in Microbiologically Evaluable at Test-of-cure Analysis Set | Enterobacteriaceae (n=26, 28) | 23 participants |
| CAZ-AVI | The Number of Patients With Clinical Cure in Patients With Pathogens Resistant to Ceftazidime at Test-of-cure (TOC) Visit in Microbiologically Evaluable at Test-of-cure Analysis Set | Enterobacter cloacae (n=5, 5) | 5 participants |
| CAZ-AVI | The Number of Patients With Clinical Cure in Patients With Pathogens Resistant to Ceftazidime at Test-of-cure (TOC) Visit in Microbiologically Evaluable at Test-of-cure Analysis Set | Escherichia coli (n=4, 4) | 4 participants |
| CAZ-AVI | The Number of Patients With Clinical Cure in Patients With Pathogens Resistant to Ceftazidime at Test-of-cure (TOC) Visit in Microbiologically Evaluable at Test-of-cure Analysis Set | Klebsiella pneumoniae (n=14, 20) | 12 participants |
| CAZ-AVI | The Number of Patients With Clinical Cure in Patients With Pathogens Resistant to Ceftazidime at Test-of-cure (TOC) Visit in Microbiologically Evaluable at Test-of-cure Analysis Set | All (n=29, 32) | 25 participants |
| Meropenem | The Number of Patients With Clinical Cure in Patients With Pathogens Resistant to Ceftazidime at Test-of-cure (TOC) Visit in Microbiologically Evaluable at Test-of-cure Analysis Set | Escherichia coli (n=4, 4) | 3 participants |
| Meropenem | The Number of Patients With Clinical Cure in Patients With Pathogens Resistant to Ceftazidime at Test-of-cure (TOC) Visit in Microbiologically Evaluable at Test-of-cure Analysis Set | All (n=29, 32) | 26 participants |
| Meropenem | The Number of Patients With Clinical Cure in Patients With Pathogens Resistant to Ceftazidime at Test-of-cure (TOC) Visit in Microbiologically Evaluable at Test-of-cure Analysis Set | Gram- pathogens not Enterobacteriaceae (n=3,6) | 6 participants |
| Meropenem | The Number of Patients With Clinical Cure in Patients With Pathogens Resistant to Ceftazidime at Test-of-cure (TOC) Visit in Microbiologically Evaluable at Test-of-cure Analysis Set | Enterobacter cloacae (n=5, 5) | 3 participants |
| Meropenem | The Number of Patients With Clinical Cure in Patients With Pathogens Resistant to Ceftazidime at Test-of-cure (TOC) Visit in Microbiologically Evaluable at Test-of-cure Analysis Set | Pseudomonas aeruginosa (n=3, 6) | 6 participants |
| Meropenem | The Number of Patients With Clinical Cure in Patients With Pathogens Resistant to Ceftazidime at Test-of-cure (TOC) Visit in Microbiologically Evaluable at Test-of-cure Analysis Set | Klebsiella pneumoniae (n=14, 20) | 17 participants |
| Meropenem | The Number of Patients With Clinical Cure in Patients With Pathogens Resistant to Ceftazidime at Test-of-cure (TOC) Visit in Microbiologically Evaluable at Test-of-cure Analysis Set | Enterobacteriaceae (n=26, 28) | 22 participants |
Secondary
The Number of Patients With Death Due to Any Cause (All-cause Mortality) at Test-of-cure (TOC) Visit in Clinically Modified Intent-to-treat Analysis Set at Test-of-cure Visit
The number of patients with death due to any cause (all-cause mortality) in clinically modified intent-to-treat analysis set at test-of-cure visit.
Time frame: At the test-of-cure (TOC) visit (Day 21 to 25)
Population: The clinical modified intent-to-treat (cMITT) included all patients who met the minimum disease criteria and received any amount of study treatment, and had either no baseline pathogens or at least one study-qualifying Gram-negative baseline pathogen.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CAZ-AVI | The Number of Patients With Death Due to Any Cause (All-cause Mortality) at Test-of-cure (TOC) Visit in Clinically Modified Intent-to-treat Analysis Set at Test-of-cure Visit | Number of patients who died (all cause mortality) | 29 participants |
| CAZ-AVI | The Number of Patients With Death Due to Any Cause (All-cause Mortality) at Test-of-cure (TOC) Visit in Clinically Modified Intent-to-treat Analysis Set at Test-of-cure Visit | Deaths due to disease progression | 10 participants |
| CAZ-AVI | The Number of Patients With Death Due to Any Cause (All-cause Mortality) at Test-of-cure (TOC) Visit in Clinically Modified Intent-to-treat Analysis Set at Test-of-cure Visit | Number of patients with any AE with outcome=death | 19 participants |
| CAZ-AVI | The Number of Patients With Death Due to Any Cause (All-cause Mortality) at Test-of-cure (TOC) Visit in Clinically Modified Intent-to-treat Analysis Set at Test-of-cure Visit | Number of patients with unknown survival status | 11 participants |
| CAZ-AVI | The Number of Patients With Death Due to Any Cause (All-cause Mortality) at Test-of-cure (TOC) Visit in Clinically Modified Intent-to-treat Analysis Set at Test-of-cure Visit | Number of patients alive | 316 participants |
| Meropenem | The Number of Patients With Death Due to Any Cause (All-cause Mortality) at Test-of-cure (TOC) Visit in Clinically Modified Intent-to-treat Analysis Set at Test-of-cure Visit | Number of patients alive | 341 participants |
| Meropenem | The Number of Patients With Death Due to Any Cause (All-cause Mortality) at Test-of-cure (TOC) Visit in Clinically Modified Intent-to-treat Analysis Set at Test-of-cure Visit | Number of patients who died (all cause mortality) | 25 participants |
| Meropenem | The Number of Patients With Death Due to Any Cause (All-cause Mortality) at Test-of-cure (TOC) Visit in Clinically Modified Intent-to-treat Analysis Set at Test-of-cure Visit | Number of patients with any AE with outcome=death | 19 participants |
| Meropenem | The Number of Patients With Death Due to Any Cause (All-cause Mortality) at Test-of-cure (TOC) Visit in Clinically Modified Intent-to-treat Analysis Set at Test-of-cure Visit | Deaths due to disease progression | 6 participants |
| Meropenem | The Number of Patients With Death Due to Any Cause (All-cause Mortality) at Test-of-cure (TOC) Visit in Clinically Modified Intent-to-treat Analysis Set at Test-of-cure Visit | Number of patients with unknown survival status | 4 participants |
Secondary
The Number of Patients With Death Due to Any Cause (All-cause Mortality) at Test-of-cure (TOC) Visit in Microbiologically Modified Intent-to-treat Analysis Set at Test-of-cure Visit
The number of patients with death due to any cause (all-cause mortality) in microbiologically modified intent-to-treat analysis set at test-of-cure visit.
Time frame: At the test-of-cure (TOC) visit (Day 21 to 25)
Population: The microbiological modified intent-to-treat (mMITT) analysis set included all patients who met the minimum disease criteria and received any amount of study treatment, and had at least one study-qualifying Gram-negative baseline pathogen.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CAZ-AVI | The Number of Patients With Death Due to Any Cause (All-cause Mortality) at Test-of-cure (TOC) Visit in Microbiologically Modified Intent-to-treat Analysis Set at Test-of-cure Visit | Number of patients who died (all cause mortality) | 16 participants |
| CAZ-AVI | The Number of Patients With Death Due to Any Cause (All-cause Mortality) at Test-of-cure (TOC) Visit in Microbiologically Modified Intent-to-treat Analysis Set at Test-of-cure Visit | Deaths due to disease progression | 6 participants |
| CAZ-AVI | The Number of Patients With Death Due to Any Cause (All-cause Mortality) at Test-of-cure (TOC) Visit in Microbiologically Modified Intent-to-treat Analysis Set at Test-of-cure Visit | Number of patients with any AE with outcome=death | 10 participants |
| CAZ-AVI | The Number of Patients With Death Due to Any Cause (All-cause Mortality) at Test-of-cure (TOC) Visit in Microbiologically Modified Intent-to-treat Analysis Set at Test-of-cure Visit | Number of patients alive | 153 participants |
| CAZ-AVI | The Number of Patients With Death Due to Any Cause (All-cause Mortality) at Test-of-cure (TOC) Visit in Microbiologically Modified Intent-to-treat Analysis Set at Test-of-cure Visit | Number of patients with unknown survival status | 2 participants |
| Meropenem | The Number of Patients With Death Due to Any Cause (All-cause Mortality) at Test-of-cure (TOC) Visit in Microbiologically Modified Intent-to-treat Analysis Set at Test-of-cure Visit | Number of patients with any AE with outcome=death | 9 participants |
| Meropenem | The Number of Patients With Death Due to Any Cause (All-cause Mortality) at Test-of-cure (TOC) Visit in Microbiologically Modified Intent-to-treat Analysis Set at Test-of-cure Visit | Number of patients who died (all cause mortality) | 14 participants |
| Meropenem | The Number of Patients With Death Due to Any Cause (All-cause Mortality) at Test-of-cure (TOC) Visit in Microbiologically Modified Intent-to-treat Analysis Set at Test-of-cure Visit | Number of patients alive | 170 participants |
| Meropenem | The Number of Patients With Death Due to Any Cause (All-cause Mortality) at Test-of-cure (TOC) Visit in Microbiologically Modified Intent-to-treat Analysis Set at Test-of-cure Visit | Deaths due to disease progression | 5 participants |
| Meropenem | The Number of Patients With Death Due to Any Cause (All-cause Mortality) at Test-of-cure (TOC) Visit in Microbiologically Modified Intent-to-treat Analysis Set at Test-of-cure Visit | Number of patients with unknown survival status | 0 participants |
Secondary
The Number of Patients With Death Due to Any Cause (All-cause Mortality) at Test-of-cure (TOC) Visit in the Clinically Evaluable at Test-of-cure Analysis Set
The number of patients with death due to any cause (all-cause mortality) in the clinically evaluable at test-of-cure analysis set.
Time frame: At the test-of-cure (TOC) visit (Day 21 to 25)
Population: The clinically evaluable (CE) analysis set included all patients in the clinical modified intent-to-treat (cMITT) analysis set who met the stringent criteria for clinical evaluation described in the protocol regarding dosing, prior and concomitant medication, evaluation, etc.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CAZ-AVI | The Number of Patients With Death Due to Any Cause (All-cause Mortality) at Test-of-cure (TOC) Visit in the Clinically Evaluable at Test-of-cure Analysis Set | Deaths due to disease progression | 5 participants |
| CAZ-AVI | The Number of Patients With Death Due to Any Cause (All-cause Mortality) at Test-of-cure (TOC) Visit in the Clinically Evaluable at Test-of-cure Analysis Set | Number of patients alive | 245 participants |
| CAZ-AVI | The Number of Patients With Death Due to Any Cause (All-cause Mortality) at Test-of-cure (TOC) Visit in the Clinically Evaluable at Test-of-cure Analysis Set | Number of patients with any AE with outcome=death | 6 participants |
| CAZ-AVI | The Number of Patients With Death Due to Any Cause (All-cause Mortality) at Test-of-cure (TOC) Visit in the Clinically Evaluable at Test-of-cure Analysis Set | Number of patients with unknown survival status | 1 participants |
| CAZ-AVI | The Number of Patients With Death Due to Any Cause (All-cause Mortality) at Test-of-cure (TOC) Visit in the Clinically Evaluable at Test-of-cure Analysis Set | Number of patients who died (all cause mortality) | 11 participants |
| Meropenem | The Number of Patients With Death Due to Any Cause (All-cause Mortality) at Test-of-cure (TOC) Visit in the Clinically Evaluable at Test-of-cure Analysis Set | Number of patients with unknown survival status | 0 participants |
| Meropenem | The Number of Patients With Death Due to Any Cause (All-cause Mortality) at Test-of-cure (TOC) Visit in the Clinically Evaluable at Test-of-cure Analysis Set | Number of patients who died (all cause mortality) | 8 participants |
| Meropenem | The Number of Patients With Death Due to Any Cause (All-cause Mortality) at Test-of-cure (TOC) Visit in the Clinically Evaluable at Test-of-cure Analysis Set | Deaths due to disease progression | 4 participants |
| Meropenem | The Number of Patients With Death Due to Any Cause (All-cause Mortality) at Test-of-cure (TOC) Visit in the Clinically Evaluable at Test-of-cure Analysis Set | Number of patients with any AE with outcome=death | 4 participants |
| Meropenem | The Number of Patients With Death Due to Any Cause (All-cause Mortality) at Test-of-cure (TOC) Visit in the Clinically Evaluable at Test-of-cure Analysis Set | Number of patients alive | 262 participants |
Secondary
The Number of Patients With Death Due to Any Cause (All-cause Mortality) in Clinically Modified Intent-to-treat Analysis Set at Day 28
The number of patients with death due to any cause (all-cause mortality) in clinically modified intent-to-treat analysis set at day 28.
Time frame: at Day 28 from randomization
Population: The clinical modified intent-to-treat (cMITT) included all patients who met the minimum disease criteria and received any amount of study treatment, and had either no baseline pathogens or at least one study-qualifying Gram-negative baseline pathogen.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CAZ-AVI | The Number of Patients With Death Due to Any Cause (All-cause Mortality) in Clinically Modified Intent-to-treat Analysis Set at Day 28 | Number of patients alive | 315 participants |
| CAZ-AVI | The Number of Patients With Death Due to Any Cause (All-cause Mortality) in Clinically Modified Intent-to-treat Analysis Set at Day 28 | Number of patients with unknown survival status | 11 participants |
| CAZ-AVI | The Number of Patients With Death Due to Any Cause (All-cause Mortality) in Clinically Modified Intent-to-treat Analysis Set at Day 28 | Deaths due to disease progression | 10 participants |
| CAZ-AVI | The Number of Patients With Death Due to Any Cause (All-cause Mortality) in Clinically Modified Intent-to-treat Analysis Set at Day 28 | Number of patients with any AE with outcome=death | 20 participants |
| CAZ-AVI | The Number of Patients With Death Due to Any Cause (All-cause Mortality) in Clinically Modified Intent-to-treat Analysis Set at Day 28 | Number of patients who died (all cause mortality) | 30 participants |
| Meropenem | The Number of Patients With Death Due to Any Cause (All-cause Mortality) in Clinically Modified Intent-to-treat Analysis Set at Day 28 | Number of patients with any AE with outcome=death | 21 participants |
| Meropenem | The Number of Patients With Death Due to Any Cause (All-cause Mortality) in Clinically Modified Intent-to-treat Analysis Set at Day 28 | Number of patients alive | 339 participants |
| Meropenem | The Number of Patients With Death Due to Any Cause (All-cause Mortality) in Clinically Modified Intent-to-treat Analysis Set at Day 28 | Deaths due to disease progression | 6 participants |
| Meropenem | The Number of Patients With Death Due to Any Cause (All-cause Mortality) in Clinically Modified Intent-to-treat Analysis Set at Day 28 | Number of patients with unknown survival status | 4 participants |
| Meropenem | The Number of Patients With Death Due to Any Cause (All-cause Mortality) in Clinically Modified Intent-to-treat Analysis Set at Day 28 | Number of patients who died (all cause mortality) | 27 participants |
Secondary
The Number of Patients With Death Due to Any Cause (All-cause Mortality) in Microbiologically Modified Intent-to-treat Analysis Set at Day 28
The number of patients with death due to any cause (all-cause mortality) in microbiologically modified intent-to-treat analysis set at day 28.
Time frame: at Day 28 from randomization
Population: The microbiological modified intent-to-treat (mMITT) analysis set included all patients who met the minimum disease criteria and received any amount of study treatment, and had at least one study-qualifying Gram-negative baseline pathogen.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CAZ-AVI | The Number of Patients With Death Due to Any Cause (All-cause Mortality) in Microbiologically Modified Intent-to-treat Analysis Set at Day 28 | Number of patients alive | 152 participants |
| CAZ-AVI | The Number of Patients With Death Due to Any Cause (All-cause Mortality) in Microbiologically Modified Intent-to-treat Analysis Set at Day 28 | Number of patients who died (all cause mortality) | 17 participants |
| CAZ-AVI | The Number of Patients With Death Due to Any Cause (All-cause Mortality) in Microbiologically Modified Intent-to-treat Analysis Set at Day 28 | Number of patients with unknown survival status | 2 participants |
| CAZ-AVI | The Number of Patients With Death Due to Any Cause (All-cause Mortality) in Microbiologically Modified Intent-to-treat Analysis Set at Day 28 | Deaths due to disease progression | 6 participants |
| CAZ-AVI | The Number of Patients With Death Due to Any Cause (All-cause Mortality) in Microbiologically Modified Intent-to-treat Analysis Set at Day 28 | Number of patients with any AE with outcome=death | 11 participants |
| Meropenem | The Number of Patients With Death Due to Any Cause (All-cause Mortality) in Microbiologically Modified Intent-to-treat Analysis Set at Day 28 | Deaths due to disease progression | 5 participants |
| Meropenem | The Number of Patients With Death Due to Any Cause (All-cause Mortality) in Microbiologically Modified Intent-to-treat Analysis Set at Day 28 | Number of patients with any AE with outcome=death | 11 participants |
| Meropenem | The Number of Patients With Death Due to Any Cause (All-cause Mortality) in Microbiologically Modified Intent-to-treat Analysis Set at Day 28 | Number of patients alive | 168 participants |
| Meropenem | The Number of Patients With Death Due to Any Cause (All-cause Mortality) in Microbiologically Modified Intent-to-treat Analysis Set at Day 28 | Number of patients with unknown survival status | 0 participants |
| Meropenem | The Number of Patients With Death Due to Any Cause (All-cause Mortality) in Microbiologically Modified Intent-to-treat Analysis Set at Day 28 | Number of patients who died (all cause mortality) | 16 participants |
Secondary
The Number of Patients With Death Due to Any Cause (All-cause Mortality) in the Clinically Evaluable at Test-of-cure Analysis Set at Day 28
The number of patients with death due to any cause (all-cause mortality) in the clinically evaluable at test-of-cure analysis set at day 28.
Time frame: at Day 28 from randomization
Population: The clinically evaluable (CE) analysis set included all patients in the clinical modified intent-to-treat (cMITT) analysis set who met the stringent criteria for clinical evaluation described in the protocol regarding dosing, prior and concomitant medication, evaluation, etc.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CAZ-AVI | The Number of Patients With Death Due to Any Cause (All-cause Mortality) in the Clinically Evaluable at Test-of-cure Analysis Set at Day 28 | Number of patients with unknown survival status | 1 participants |
| CAZ-AVI | The Number of Patients With Death Due to Any Cause (All-cause Mortality) in the Clinically Evaluable at Test-of-cure Analysis Set at Day 28 | Number of patients with any AE with outcome=death | 7 participants |
| CAZ-AVI | The Number of Patients With Death Due to Any Cause (All-cause Mortality) in the Clinically Evaluable at Test-of-cure Analysis Set at Day 28 | Number of patients alive | 244 participants |
| CAZ-AVI | The Number of Patients With Death Due to Any Cause (All-cause Mortality) in the Clinically Evaluable at Test-of-cure Analysis Set at Day 28 | Deaths due to disease progression | 5 participants |
| CAZ-AVI | The Number of Patients With Death Due to Any Cause (All-cause Mortality) in the Clinically Evaluable at Test-of-cure Analysis Set at Day 28 | Number of patients who died (all cause mortality) | 12 participants |
| Meropenem | The Number of Patients With Death Due to Any Cause (All-cause Mortality) in the Clinically Evaluable at Test-of-cure Analysis Set at Day 28 | Number of patients with unknown survival status | 0 participants |
| Meropenem | The Number of Patients With Death Due to Any Cause (All-cause Mortality) in the Clinically Evaluable at Test-of-cure Analysis Set at Day 28 | Number of patients who died (all cause mortality) | 9 participants |
| Meropenem | The Number of Patients With Death Due to Any Cause (All-cause Mortality) in the Clinically Evaluable at Test-of-cure Analysis Set at Day 28 | Deaths due to disease progression | 4 participants |
| Meropenem | The Number of Patients With Death Due to Any Cause (All-cause Mortality) in the Clinically Evaluable at Test-of-cure Analysis Set at Day 28 | Number of patients alive | 261 participants |
| Meropenem | The Number of Patients With Death Due to Any Cause (All-cause Mortality) in the Clinically Evaluable at Test-of-cure Analysis Set at Day 28 | Number of patients with any AE with outcome=death | 5 participants |