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

NCT01808092 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 969

Last updated 2017-09-06

Study results available
· View outcomes & findings →

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

Conditions

  • Nosocomial Pneumonia (NP)
  • Ventilator-associated Pneumonia (VAP)

Interventions

DRUG

ceftazidim-avibactam (CAZ-AVI, experimental product)

2000mg ceftazidime plus 500mg avibactam

DRUG

meropenem (active comparator)

1000mg of Meropenem

Sponsors & Collaborators

Principal Investigators

  • Joseph Chow, MD, FIDSA · AstraZeneca

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-04-30
Primary Completion
2016-01-31
Completion
2016-01-31

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

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01808092 on ClinicalTrials.gov