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A Study Comparing Ceftazidime-Avibactam Versus Meropenem in Hospitalized Adults With Nosocomial Pneumonia

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01808092
First received: February 28, 2013
Last updated: December 9, 2016
Last verified: December 2016
  Purpose
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

Condition Intervention Phase
Nosocomial Pneumonia (NP)
Ventilator-associated Pneumonia (VAP)
Drug: ceftazidime-avibactam
Drug: meropenem
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • The Proportion of Patients With Clinical Cure at Test-of-cure (TOC) Visit in the Clinically Modified Intent-to-treat Analysis Set (Co-primary Analyses) [ Time Frame: At the test-of-cure (TOC) visit (Day 21 to 25) ]
    The proportion 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 Proportion of Patients With Clinical Cure at Test-of-cure (TOC) Visit in the Clinically Evaluable at TOC Analysis Set (Co-primary Analyses) [ Time Frame: At the test-of-cure (TOC) visit (Day 21 to 25) ]
    The proportion 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 Outcome Measures:
  • The Proportion of Patients With Clinical Cure at Test-of-cure (TOC) Visit in the Microbiologically Modified Intent-to-treat Analysis Set [ Time Frame: At the test-of-cure (TOC) visit (Day 21 to 25) ]
    The proportion 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 Proportion of Patients With Clinical Cure at Test-of-cure (TOC) Visit in the Extended Microbiologically Evaluable Analysis Set [ Time Frame: At the test-of-cure (TOC) visit (Day 21 to 25) ]
    The proportion 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 Proportion of Patients With Clinical Cure at Test-of-cure (TOC) Visit in the Microbiologically Evaluable Analysis Set [ Time Frame: At the test-of-cure (TOC) visit (Day 21 to 25) ]
    The proportion 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 Proportion of Patients With Clinical Cure at End of Treatment (EOT) Visit in Microbiologically Modified Intent-to-treat Analysis Set [ Time Frame: At the end of treatment (EOT) visit (within 24 hours after last IV dose) ]
    The proportion 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 Proportion of Patients With Clinical Cure at End of Treatment (EOT) Visit in Clinically Modified Intent-to-treat Analysis Set [ Time Frame: At the end of treatment (EOT) visit (within 24 hours after last IV dose) ]
    The proportion 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 Proportion of Patients With Clinical Cure at End of Treatment (EOT) Visit in Clinically Evaluable Analysis Set [ Time Frame: At the end of treatment (EOT) visit (within 24 hours after last IV dose) ]
    The proportion 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 Proportion of Patients With Clinical Cure at End of Treatment (EOT) Visit in Extended Microbiologically Evaluable Analysis Set [ Time Frame: At the end of treatment (EOT) visit (within 24 hours after last IV dose) ]
    The proportion 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 Proportion of Patients With Clinical Cure at End of Treatment (EOT) Visit in Microbiologically Evaluable Analysis Set [ Time Frame: At the end of treatment (EOT) visit (within 24 hours after last IV dose) ]
    The proportion 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 Proportion of Patients With a Favorable Per-patient Microbiologic Response at End of Treatment (EOT) Visit in Microbiologically Modified Intent-to-treat Analysis Set [ Time Frame: At the end of treatment (EOT) visit (within 24 hours after last IV dose) ]
    Per-patient "favorable" response indicates that all of the patient's baseline pathogens are "eradicated" or "presumed eradicated". 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 Proportion of Patients With a Favorable Per-patient Microbiologic Response at Test-of-cure (TOC) Visit in Microbiologically Modified Intent-to-treat Analysis Set [ Time Frame: 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 Proportion 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 [ Time Frame: At the end of treatment (EOT) visit (within 24 hours after last IV dose) ]
    Per-patient "favorable" response indicates that all of the patient's baseline pathogens are "eradicated" or "presumed eradicated". 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 Proportion 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 [ Time Frame: 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 Proportion of Patients With a Favorable Per-patient Microbiologic Response at End of Treatment (EOT) Visit in Microbiologically Evaluable at End of Treatment Analysis Set [ Time Frame: At the end of treatment (EOT) visit (within 24 hours after last IV dose) ]
    Per-patient "favorable" response indicates that all of the patient's baseline pathogens are "eradicated" or "presumed eradicated". 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 Proportion of Patients With a Favorable Per-patient Microbiologic Response at Test-of-cure (TOC) Visit in Microbiologically Evaluable at Test-of-cure Analysis Set [ Time Frame: 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 Proportion 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 [ Time Frame: At the end of treatment (EOT) visit (within 24 hours after last IV dose) ]
    The proportion 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 Proportion of Favorable Per-pathogen Microbiologic Responses at End of Treatment (EOT) Visit in Extended Microbiologically Evaluable at End of Treatment Analysis Set [ Time Frame: At the end of treatment (EOT) visit (within 24 hours after last IV dose) ]
    The proportion 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 Proportion of Favorable Per-pathogen Microbiologic Responses at End of Treatment (EOT) Visit in Microbiologically Evaluable at End of Treatment Analysis Set [ Time Frame: At the end of treatment (EOT) visit (within 24 hours after last IV dose) ]
    The proportion 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 Proportion 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 [ Time Frame: At the test-of-cure (TOC) visit (Day 21 to 25) ]
    The proportion 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 Proportion of Favorable Per-pathogen Microbiologic Responses at Test-of-cure (TOC) Visit in Extended Microbiologically Evaluable at Test-of-cure Analysis Set [ Time Frame: At the test-of-cure (TOC) visit (Day 21 to 25) ]
    The proportion 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 Proportion of Favorable Per-pathogen Microbiologic Responses at Test-of-cure (TOC) Visit in Microbiologically Evaluable at Test-of-cure Analysis Set [ Time Frame: At the test-of-cure (TOC) visit (Day 21 to 25) ]
    The proportion 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 Proportion 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 [ Time Frame: At the end of treatment (EOT) visit (within 24 hours after last IV dose) ]
    The proportion 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 Proportion 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 [ Time Frame: At the end of treatment (EOT) visit (within 24 hours after last IV dose) ]
    The proportion 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 Proportion 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 [ Time Frame: At the end of treatment (EOT) visit (within 24 hours after last IV dose) ]
    The proportion 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 Proportion 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 [ Time Frame: At the test-of-cure (TOC) visit (Day 21 to 25) ]
    The proportion 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 Proportion 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 [ Time Frame: At the test-of-cure (TOC) visit (Day 21 to 25) ]
    The proportion 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 Proportion 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 [ Time Frame: At the test-of-cure (TOC) visit (Day 21 to 25) ]
    The proportion 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.

  • Proportion 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 [ Time Frame: At the end of treatment (EOT) visit (within 24 hours after last IV dose) ]
    Per-patient "favorable" response indicates that all of the patient's baseline pathogens are "eradicated" or "presumed eradicated". 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.

  • Proportion 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 [ Time Frame: At the end of treatment (EOT) visit (within 24 hours after last IV dose) ]
    Per-patient "favorable" response indicates that all of the patient's baseline pathogens are "eradicated" or "presumed eradicated". 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.

  • Proportion 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 [ Time Frame: At the end of treatment (EOT) visit (within 24 hours after last IV dose) ]
    Per-patient "favorable" response indicates that all of the patient's baseline pathogens are "eradicated" or "presumed eradicated". 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.

  • Proportion 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 [ Time Frame: 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.

  • Proportion 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 [ Time Frame: 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.

  • Proportion 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 [ Time Frame: 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 Proportion 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 [ Time Frame: At the end of treatment (EOT) visit (within 24 hours after last IV dose) ]
    The proportion 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 Proportion 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 [ Time Frame: At the end of treatment (EOT) visit (within 24 hours after last IV dose) ]
    The proportion 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 Proportion 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 [ Time Frame: At the end of treatment (EOT) visit (within 24 hours after last IV dose) ]
    The proportion 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 Proportion 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 [ Time Frame: At the test-of-cure (TOC) visit (Day 21 to 25) ]
    The proportion 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 Proportion 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 [ Time Frame: At the test-of-cure (TOC) visit (Day 21 to 25) ]
    The proportion 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 Proportion 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 [ Time Frame: At the test-of-cure (TOC) visit (Day 21 to 25) ]
    The proportion 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 Proportion 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 [ Time Frame: At the test-of-cure (TOC) visit (Day 21 to 25) ]
    The proportion 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 Proportion 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 [ Time Frame: At the test-of-cure (TOC) visit (Day 21 to 25) ]
    The proportion 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 Proportion 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 [ Time Frame: At the test-of-cure (TOC) visit (Day 21 to 25) ]
    The proportion of patients with death due to any cause (all-cause mortality) in the clinically evaluable at test-of-cure analysis set.

  • The Proportion 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 ]
    The proportion of patients with death due to any cause (all-cause mortality) in microbiologically modified intent-to-treat analysis set at day 28.

  • The Proportion 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 ]
    The proportion of patients with death due to any cause (all-cause mortality) in clinically modified intent-to-treat analysis set at day 28.

  • The Proportion 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 ]
    The proportion 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 Proportion of Patients Discharged From Hospital up to Test-of-cure (TOC) Visit in Microbiologically Modified Intent-to-treat Analysis Set [ Time Frame: up to 25 days from randomization ]
    The proportion of patients discharged from hospital in microbiologically modified intent-to-treat analysis set.

  • The Proportion of Patients Discharged From Hospital up to Test-of-cure (TOC) Visit in the Clinically Modified Intent-to-treat Analysis Set [ Time Frame: up to 25 days from randomization ]
    The proportion of patients discharged from hospital in the clinically modified intent-to-treat analysis set.

  • The Proportion of Patients Discharged From Hospital up to Test-of-cure (TOC) Visit in the Clinically Evaluable at Test-of-cure Analysis Set [ Time Frame: up to 25 days from randomization ]
    The proportion of patients discharged from hospital in the clinically evaluable at test-of-cure analysis set.


Enrollment: 969
Study Start Date: April 2013
Study Completion Date: January 2016
Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Intra-Venous treatment
Drug: ceftazidime-avibactam
2000mg ceftazidime plus 500mg avibactam
Active Comparator: 2
Intra-Venous treatment
Drug: meropenem
1000mg of Meropenem

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
  Eligibility

Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01808092

  Show 125 Study Locations
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Joseph Chow, MD, FIDSA AstraZeneca
  More Information

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01808092     History of Changes
Other Study ID Numbers: D4281C00001 
Study First Received: February 28, 2013
Results First Received: December 9, 2016
Last Updated: December 9, 2016

Keywords provided by AstraZeneca:
Ceftazidime,
Meropenem,
Anti-Bacterial Agents,
Anti-Infective Agents,
Therapeutic Uses,
Pharmacologic Actions,
Physiological Effects of Drugs

Additional relevant MeSH terms:
Pneumonia
Pneumonia, Ventilator-Associated
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Cross Infection
Infection
Ventilator-Induced Lung Injury
Lung Injury
Avibactam, ceftazidime drug combination
Avibactam
Ceftazidime
Meropenem
Thienamycins
beta-Lactamase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Bacterial Agents
Anti-Infective Agents

ClinicalTrials.gov processed this record on February 27, 2017