| 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. | 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. | Posted | | Number | | participants | | At the test-of-cure (TOC) visit (Day 21 to 25) | | | | ID | Title | Description |
|---|
| OG000 | CAZ-AVI | 2000mg ceftazidime / 500mg avibactam intravenous (IV) infused over 2 hours plus appropriate placebo to meropenem | | OG001 | Meropenem | meropenem 1000mg IV infused over 30 minutes plus CAZ-AVI placebo |
| | | Title | Denominators | Categories |
|---|
| Clinical cure | | | | Clinical failure | | |
| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
|---|
| Statistical analysis for the proportion of patients with clinical cure at TOC in cMITT analysis set | % Risk Difference (RD) | RD is CAZ-AVI clinical cure rate minus Meropenem clinical cure rate. The CI was calculated by Miettinen and Nurminen method without adjustment. | 0.007 | P-value for 1-sided test at test of cure (TOC) with a -12.5% non-inferiority margin, i.e. H0: diff <= -12.5%. | percentage: units for RD are % | -4.2 | | | 2-Sided | 95 | -10.76 | 2.46 | | | | | Non-Inferiority or Equivalence | |
|
| 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. | 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. | Posted | | Number | | participants | | At the test-of-cure (TOC) visit (Day 21 to 25) | | | | ID | Title | Description |
|---|
| OG000 | CAZ-AVI | 2000mg ceftazidime / 500mg avibactam intravenous (IV) infused over 2 hours plus appropriate placebo to meropenem | | OG001 | Meropenem | meropenem 1000mg IV infused over 30 minutes plus CAZ-AVI placebo |
| |
| 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. | 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. | Posted | | Number | | participants | | At the test-of-cure (TOC) visit (Day 21 to 25) | | | | ID | Title | Description |
|---|
| OG000 | CAZ-AVI | 2000mg ceftazidime / 500mg avibactam intravenous (IV) infused over 2 hours plus appropriate placebo to meropenem | | OG001 | Meropenem | meropenem 1000mg IV infused over 30 minutes plus CAZ-AVI placebo |
| |
| 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. | 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. | Posted | | Number | | participants | | At the test-of-cure (TOC) visit (Day 21 to 25) | | | | ID | Title | Description |
|---|
| OG000 | CAZ-AVI | 2000mg ceftazidime / 500mg avibactam intravenous (IV) infused over 2 hours plus appropriate placebo to meropenem | | OG001 | Meropenem | meropenem 1000mg IV infused over 30 minutes plus CAZ-AVI placebo |
| |
| 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. | 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). | Posted | | Number | | participants | | At the test-of-cure (TOC) visit (Day 21 to 25) | | | | ID | Title | Description |
|---|
| OG000 | CAZ-AVI | 2000mg ceftazidime / 500mg avibactam intravenous (IV) infused over 2 hours plus appropriate placebo to meropenem | | OG001 | Meropenem | meropenem 1000mg IV infused over 30 minutes plus CAZ-AVI placebo |
| |
| 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. | 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. | Posted | | Number | | participants | | Patients were followed after the last IV dose but no later than 24 hours after the last IV dose. | | | | ID | Title | Description |
|---|
| OG000 | CAZ-AVI | 2000mg ceftazidime / 500mg avibactam intravenous (IV) infused over 2 hours plus appropriate placebo to meropenem | | OG001 | Meropenem | meropenem 1000mg IV infused over 30 minutes plus CAZ-AVI placebo |
| |
| 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. | 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. | Posted | | Number | | participants | | Patients were followed after the last IV dose but no later than 24 hours after the last IV dose. | | | | ID | Title | Description |
|---|
| OG000 | CAZ-AVI | 2000mg ceftazidime / 500mg avibactam intravenous (IV) infused over 2 hours plus appropriate placebo to meropenem | | OG001 | Meropenem | meropenem 1000mg IV infused over 30 minutes plus CAZ-AVI placebo |
| |
| 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. | 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. | Posted | | Number | | participants | | Patients were followed after the last IV dose but no later than 24 hours after the last IV dose. | | | | ID | Title | Description |
|---|
| OG000 | CAZ-AVI | 2000mg ceftazidime / 500mg avibactam intravenous (IV) infused over 2 hours plus appropriate placebo to meropenem | | OG001 | Meropenem | meropenem 1000mg IV infused over 30 minutes plus CAZ-AVI placebo |
| |
| 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. | 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. | Posted | | Number | | participants | | Patients were followed after the last IV dose but no later than 24 hours after the last IV dose. | | | | ID | Title | Description |
|---|
| OG000 | CAZ-AVI | 2000mg ceftazidime / 500mg avibactam intravenous (IV) infused over 2 hours plus appropriate placebo to meropenem | | OG001 | Meropenem | meropenem 1000mg IV infused over 30 minutes plus CAZ-AVI placebo |
| |
| 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. | 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). | Posted | | Number | | participants | | Patients were followed after the last IV dose but no later than 24 hours after the last IV dose. | | | | ID | Title | Description |
|---|
| OG000 | CAZ-AVI | 2000mg ceftazidime / 500mg avibactam intravenous (IV) infused over 2 hours plus appropriate placebo to meropenem | | OG001 | Meropenem | meropenem 1000mg IV infused over 30 minutes plus CAZ-AVI placebo |
| |
| 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. | 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. | Posted | | Number | | participants | | Patients were followed after the last IV dose but no later than 24 hours after the last IV dose. | | | | ID | Title | Description |
|---|
| OG000 | CAZ-AVI | 2000mg ceftazidime / 500mg avibactam intravenous (IV) infused over 2 hours plus appropriate placebo to meropenem | | OG001 | Meropenem | meropenem 1000mg IV infused over 30 minutes plus CAZ-AVI placebo |
| |
| 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. | 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. | Posted | | Number | | participants | | At the test-of-cure (TOC) visit (Day 21 to 25) | | | | ID | Title | Description |
|---|
| OG000 | CAZ-AVI | 2000mg ceftazidime / 500mg avibactam intravenous (IV) infused over 2 hours plus appropriate placebo to meropenem | | OG001 | Meropenem | meropenem 1000mg IV infused over 30 minutes plus CAZ-AVI placebo |
| |
| 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. | 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. | Posted | | Number | | participants | | Patients were followed after the last IV dose but no later than 24 hours after the last IV dose. | | | | ID | Title | Description |
|---|
| OG000 | CAZ-AVI | 2000mg ceftazidime / 500mg avibactam intravenous (IV) infused over 2 hours plus appropriate placebo to meropenem | | OG001 | Meropenem | meropenem 1000mg IV infused over 30 minutes plus CAZ-AVI placebo |
| |
| 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. | 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. | Posted | | Number | | participants | | At the test-of-cure (TOC) visit (Day 21 to 25) | | | | ID | Title | Description |
|---|
| OG000 | CAZ-AVI | 2000mg ceftazidime / 500mg avibactam intravenous (IV) infused over 2 hours plus appropriate placebo to meropenem | | OG001 | Meropenem | meropenem 1000mg IV infused over 30 minutes plus CAZ-AVI placebo |
| |
| 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. | 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). | Posted | | Number | | participants | | Patients were followed after the last IV dose but no later than 24 hours after the last IV dose. | | | | ID | Title | Description |
|---|
| OG000 | CAZ-AVI | 2000mg ceftazidime / 500mg avibactam intravenous (IV) infused over 2 hours plus appropriate placebo to meropenem | | OG001 | Meropenem | meropenem 1000mg IV infused over 30 minutes plus CAZ-AVI placebo |
| |
| 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. | 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). | Posted | | Number | | participants | | At the test-of-cure (TOC) visit (Day 21 to 25) | | | | ID | Title | Description |
|---|
| OG000 | CAZ-AVI | 2000mg ceftazidime / 500mg avibactam intravenous (IV) infused over 2 hours plus appropriate placebo to meropenem | | OG001 | Meropenem | meropenem 1000mg IV infused over 30 minutes plus CAZ-AVI placebo |
| |
| 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. | 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) | Posted | | Number | | participants with favorable responses | | Patients were followed after the last IV dose but no later than 24 hours after the last IV dose. | | | | ID | Title | Description |
|---|
| OG000 | CAZ-AVI | 2000mg ceftazidime / 500mg avibactam intravenous (IV) infused over 2 hours plus appropriate placebo to meropenem | | OG001 | Meropenem | meropenem 1000mg IV infused over 30 minutes plus CAZ-AVI placebo |
| |
| 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. | 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) | Posted | | Number | | participants with favorable responses | | Patients were followed after the last IV dose but no later than 24 hours after the last IV dose. | | | | ID | Title | Description |
|---|
| OG000 | CAZ-AVI | 2000mg ceftazidime / 500mg avibactam intravenous (IV) infused over 2 hours plus appropriate placebo to meropenem | | OG001 | Meropenem | meropenem 1000mg IV infused over 30 minutes plus CAZ-AVI placebo |
| |
| 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. | 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) | Posted | | Number | | participants with favorable responses | | Patients were followed after the last IV dose but no later than 24 hours after the last IV dose. | | | | ID | Title | Description |
|---|
| OG000 | CAZ-AVI | 2000mg ceftazidime / 500mg avibactam intravenous (IV) infused over 2 hours plus appropriate placebo to meropenem | | OG001 | Meropenem | meropenem 1000mg IV infused over 30 minutes plus CAZ-AVI placebo |
| |
| 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. | 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) | Posted | | Number | | participants with favorable responses | | At the test-of-cure (TOC) visit (Day 21 to 25) | | | | ID | Title | Description |
|---|
| OG000 | CAZ-AVI | 2000mg ceftazidime / 500mg avibactam intravenous (IV) infused over 2 hours plus appropriate placebo to meropenem | | OG001 | Meropenem | meropenem 1000mg IV infused over 30 minutes plus CAZ-AVI placebo |
| |
| 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. | 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) | Posted | | Number | | participants with favorable responses | | At the test-of-cure (TOC) visit (Day 21 to 25) | | | | ID | Title | Description |
|---|
| OG000 | CAZ-AVI | 2000mg ceftazidime / 500mg avibactam intravenous (IV) infused over 2 hours plus appropriate placebo to meropenem | | OG001 | Meropenem | meropenem 1000mg IV infused over 30 minutes plus CAZ-AVI placebo |
| |
| 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. | 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) | Posted | | Number | | participants with favorable responses | | At the test-of-cure (TOC) visit (Day 21 to 25) | | | | ID | Title | Description |
|---|
| OG000 | CAZ-AVI | 2000mg ceftazidime / 500mg avibactam intravenous (IV) infused over 2 hours plus appropriate placebo to meropenem | | OG001 | Meropenem | meropenem 1000mg IV infused over 30 minutes plus CAZ-AVI placebo |
| |
| 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. | 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) | Posted | | Number | | participants | | Patients were followed after the last IV dose but no later than 24 hours after the last IV dose. | | | | ID | Title | Description |
|---|
| OG000 | CAZ-AVI | 2000mg ceftazidime / 500mg avibactam intravenous (IV) infused over 2 hours plus appropriate placebo to meropenem | | OG001 | Meropenem | meropenem 1000mg IV infused over 30 minutes plus CAZ-AVI placebo |
| |
| 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. | 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) | Posted | | Number | | participants | | Patients were followed after the last IV dose but no later than 24 hours after the last IV dose. | | | | ID | Title | Description |
|---|
| OG000 | CAZ-AVI | 2000mg ceftazidime / 500mg avibactam intravenous (IV) infused over 2 hours plus appropriate placebo to meropenem | | OG001 | Meropenem | meropenem 1000mg IV infused over 30 minutes plus CAZ-AVI placebo |
| |
| 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. | 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) | Posted | | Number | | participants | | Patients were followed after the last IV dose but no later than 24 hours after the last IV dose. | | | | ID | Title | Description |
|---|
| OG000 | CAZ-AVI | 2000mg ceftazidime / 500mg avibactam intravenous (IV) infused over 2 hours plus appropriate placebo to meropenem | | OG001 | Meropenem | meropenem 1000mg IV infused over 30 minutes plus CAZ-AVI placebo |
| |
| 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. | 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) | Posted | | Number | | participants | | At the test-of-cure (TOC) visit (Day 21 to 25) | | | | ID | Title | Description |
|---|
| OG000 | CAZ-AVI | 2000mg ceftazidime / 500mg avibactam intravenous (IV) infused over 2 hours plus appropriate placebo to meropenem | | OG001 | Meropenem | meropenem 1000mg IV infused over 30 minutes plus CAZ-AVI placebo |
| |
| 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. | 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) | Posted | | Number | | participants | | At the test-of-cure (TOC) visit (Day 21 to 25) | | | | ID | Title | Description |
|---|
| OG000 | CAZ-AVI | 2000mg ceftazidime / 500mg avibactam intravenous (IV) infused over 2 hours plus appropriate placebo to meropenem | | OG001 | Meropenem | meropenem 1000mg IV infused over 30 minutes plus CAZ-AVI placebo |
| |
| 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. | 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) | Posted | | Number | | participants | | At the test-of-cure (TOC) visit (Day 21 to 25) | | | | ID | Title | Description |
|---|
| OG000 | CAZ-AVI | 2000mg ceftazidime / 500mg avibactam intravenous (IV) infused over 2 hours plus appropriate placebo to meropenem | | OG001 | Meropenem | meropenem 1000mg IV infused over 30 minutes plus CAZ-AVI placebo |
| |
| 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. | 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 | Posted | | Number | | participants | | Patients were followed after the last IV dose but no later than 24 hours after the last IV dose. | | | | ID | Title | Description |
|---|
| OG000 | CAZ-AVI | 2000mg ceftazidime / 500mg avibactam intravenous (IV) infused over 2 hours plus appropriate placebo to meropenem | | OG001 | Meropenem | meropenem 1000mg IV infused over 30 minutes plus CAZ-AVI placebo |
| |
| 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. | 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 | Posted | | Number | | participants | | Patients were followed after the last IV dose but no later than 24 hours after the last IV dose. | | | | ID | Title | Description |
|---|
| OG000 | CAZ-AVI | 2000mg ceftazidime / 500mg avibactam intravenous (IV) infused over 2 hours plus appropriate placebo to meropenem | | OG001 | Meropenem | meropenem 1000mg IV infused over 30 minutes plus CAZ-AVI placebo |
| |
| 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. | 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 | Posted | | Number | | participants | | Patients were followed after the last IV dose but no later than 24 hours after the last IV dose. | | | | ID | Title | Description |
|---|
| OG000 | CAZ-AVI | 2000mg ceftazidime / 500mg avibactam intravenous (IV) infused over 2 hours plus appropriate placebo to meropenem | | OG001 | Meropenem | meropenem 1000mg IV infused over 30 minutes plus CAZ-AVI placebo |
| |
| 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. | 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 | Posted | | Number | | participants | | At the test-of-cure (TOC) visit (Day 21 to 25) | | | | ID | Title | Description |
|---|
| OG000 | CAZ-AVI | 2000mg ceftazidime / 500mg avibactam intravenous (IV) infused over 2 hours plus appropriate placebo to meropenem | | OG001 | Meropenem | meropenem 1000mg IV infused over 30 minutes plus CAZ-AVI placebo |
| |
| 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. | 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 | Posted | | Number | | participants | | At the test-of-cure (TOC) visit (Day 21 to 25) | | | | ID | Title | Description |
|---|
| OG000 | CAZ-AVI | 2000mg ceftazidime / 500mg avibactam intravenous (IV) infused over 2 hours plus appropriate placebo to meropenem | | OG001 | Meropenem | meropenem 1000mg IV infused over 30 minutes plus CAZ-AVI placebo |
| |
| 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. | 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 | Posted | | Number | | participants | | At the test-of-cure (TOC) visit (Day 21 to 25) | | | | ID | Title | Description |
|---|
| OG000 | CAZ-AVI | 2000mg ceftazidime / 500mg avibactam intravenous (IV) infused over 2 hours plus appropriate placebo to meropenem | | OG001 | Meropenem | meropenem 1000mg IV infused over 30 minutes plus CAZ-AVI placebo |
| |
| 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. | 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) | Posted | | Number | | participants with favorable responses | | Patients were followed after the last IV dose but no later than 24 hours after the last IV dose. | | | | ID | Title | Description |
|---|
| OG000 | CAZ-AVI | 2000mg ceftazidime / 500mg avibactam intravenous (IV) infused over 2 hours plus appropriate placebo to meropenem | | OG001 | Meropenem | meropenem 1000mg IV infused over 30 minutes plus CAZ-AVI placebo |
| |
| 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. | 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) | Posted | | Number | | participants with favorable responses | | Patients were followed after the last IV dose but no later than 24 hours after the last IV dose. | | | | ID | Title | Description |
|---|
| OG000 | CAZ-AVI | 2000mg ceftazidime / 500mg avibactam intravenous (IV) infused over 2 hours plus appropriate placebo to meropenem | | OG001 | Meropenem | meropenem 1000mg IV infused over 30 minutes plus CAZ-AVI placebo |
| |
| 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. | 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) | Posted | | Number | | participants with favorable responses | | Patients were followed after the last IV dose but no later than 24 hours after the last IV dose. | | | | ID | Title | Description |
|---|
| OG000 | CAZ-AVI | 2000mg ceftazidime / 500mg avibactam intravenous (IV) infused over 2 hours plus appropriate placebo to meropenem | | OG001 | Meropenem | meropenem 1000mg IV infused over 30 minutes plus CAZ-AVI placebo |
| |
| 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. | 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) | Posted | | Number | | participants with favorable responses | | At the test-of-cure (TOC) visit (Day 21 to 25) | | | | ID | Title | Description |
|---|
| OG000 | CAZ-AVI | 2000mg ceftazidime / 500mg avibactam intravenous (IV) infused over 2 hours plus appropriate placebo to meropenem | | OG001 | Meropenem | meropenem 1000mg IV infused over 30 minutes plus CAZ-AVI placebo |
| |
| 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. | 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) | Posted | | Number | | participants with favorable responses | | At the test-of-cure (TOC) visit (Day 21 to 25) | | | | ID | Title | Description |
|---|
| OG000 | CAZ-AVI | 2000mg ceftazidime / 500mg avibactam intravenous (IV) infused over 2 hours plus appropriate placebo to meropenem | | OG001 | Meropenem | meropenem 1000mg IV infused over 30 minutes plus CAZ-AVI placebo |
| |
| 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. | 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) | Posted | | Number | | participants with favorable responses | | At the test-of-cure (TOC) visit (Day 21 to 25) | | | | ID | Title | Description |
|---|
| OG000 | CAZ-AVI | 2000mg ceftazidime / 500mg avibactam intravenous (IV) infused over 2 hours plus appropriate placebo to meropenem | | OG001 | Meropenem | meropenem 1000mg IV infused over 30 minutes plus CAZ-AVI placebo |
| |
| 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. | 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. | Posted | | Number | | participants | | At the test-of-cure (TOC) visit (Day 21 to 25) | | | | ID | Title | Description |
|---|
| OG000 | CAZ-AVI | 2000mg ceftazidime / 500mg avibactam intravenous (IV) infused over 2 hours plus appropriate placebo to meropenem | | OG001 | Meropenem | meropenem 1000mg IV infused over 30 minutes plus CAZ-AVI placebo |
| |
| 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. | 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. | Posted | | Number | | participants | | At the test-of-cure (TOC) visit (Day 21 to 25) | | | | ID | Title | Description |
|---|
| OG000 | CAZ-AVI | 2000mg ceftazidime / 500mg avibactam intravenous (IV) infused over 2 hours plus appropriate placebo to meropenem | | OG001 | Meropenem | meropenem 1000mg IV infused over 30 minutes plus CAZ-AVI placebo |
| |
| 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. | 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. | Posted | | Number | | participants | | At the test-of-cure (TOC) visit (Day 21 to 25) | | | | ID | Title | Description |
|---|
| OG000 | CAZ-AVI | 2000mg ceftazidime / 500mg avibactam intravenous (IV) infused over 2 hours plus appropriate placebo to meropenem | | OG001 | Meropenem | meropenem 1000mg IV infused over 30 minutes plus CAZ-AVI placebo |
| |
| 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. | 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. | Posted | | Number | | participants | | at Day 28 from randomization | | | | ID | Title | Description |
|---|
| OG000 | CAZ-AVI | 2000mg ceftazidime / 500mg avibactam intravenous (IV) infused over 2 hours plus appropriate placebo to meropenem | | OG001 | Meropenem | meropenem 1000mg IV infused over 30 minutes plus CAZ-AVI placebo |
| |
| 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. | 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. | Posted | | Number | | participants | | at Day 28 from randomization | | | | ID | Title | Description |
|---|
| OG000 | CAZ-AVI | 2000mg ceftazidime / 500mg avibactam intravenous (IV) infused over 2 hours plus appropriate placebo to meropenem | | OG001 | Meropenem | meropenem 1000mg IV infused over 30 minutes plus CAZ-AVI placebo |
| |
| 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. | 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. | Posted | | Number | | participants | | at Day 28 from randomization | | | | ID | Title | Description |
|---|
| OG000 | CAZ-AVI | 2000mg ceftazidime / 500mg avibactam intravenous (IV) infused over 2 hours plus appropriate placebo to meropenem | | OG001 | Meropenem | meropenem 1000mg IV infused over 30 minutes plus CAZ-AVI placebo |
| |
| 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. | 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. | Posted | | Number | | participants | | up to 25 days from randomization | | | | ID | Title | Description |
|---|
| OG000 | CAZ-AVI | 2000mg ceftazidime / 500mg avibactam intravenous (IV) infused over 2 hours plus appropriate placebo to meropenem | | OG001 | Meropenem | meropenem 1000mg IV infused over 30 minutes plus CAZ-AVI placebo |
| |
| 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. | 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. | Posted | | Number | | participants | | up to 25 days from randomization | | | | ID | Title | Description |
|---|
| OG000 | CAZ-AVI | 2000mg ceftazidime / 500mg avibactam intravenous (IV) infused over 2 hours plus appropriate placebo to meropenem | | OG001 | Meropenem | meropenem 1000mg IV infused over 30 minutes plus CAZ-AVI placebo |
| |
| 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. | 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. | Posted | | Number | | participants | | up to 25 days from randomization | | | | ID | Title | Description |
|---|
| OG000 | CAZ-AVI | 2000mg ceftazidime / 500mg avibactam intravenous (IV) infused over 2 hours plus appropriate placebo to meropenem | | OG001 | Meropenem | meropenem 1000mg IV infused over 30 minutes plus CAZ-AVI placebo |
| |