A study comparing Ceftazidime-Avibactam versus Meropenem in hospitalized adults with nosocomial pneumonia

Study identifier:D4281C00001

ClinicalTrials.gov identifier:NCT01808092

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

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

Medical condition

Nosocomial pneumonia (NP)

Phase

Phase 3

Healthy volunteers

No

Study drug

ceftazidim-avibactam (CAZ-AVI, experimental product), meropenem (active comparator)

Sex

All

Actual Enrollment

969

Study type

Interventional

Age

18 Years - 90 Years

Date

Study Start Date: 01 Apr 2013
Primary Completion Date: 01 Jan 2016
Study Completion Date: 01 Jan 2016

Study design

Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Treatment

Verification:

Verified 01 Feb 2017 by AstraZeneca

Sponsors

AstraZeneca

Collaborators

-

Inclusion and exclusion criteria