Conditions: Nosocomial Pneumonia (NP) Ventilator-associated Pneumonia (VAP)
Keywords: Ceftazidime, Meropenem, Anti-Bacterial Agents, Anti-Infective Agents, Therapeutic Uses, Pharmacologic Actions, Physiological Effects of Drugs
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 969
Healthy volunteers: no

Brief summary:
The purpose of the study is to evaluate the effects of Ceftazidime-Avibactam compared to Meropenem for treating hospitalized adults with nosocomial pneumonia including ventilator-associated pneumonia

Detailed description:
A Phase III, Randomized, Multicentre, Double-blind, Double-dummy, Parallel-group Comparative Study to Determine the Efficacy, Safety And Tolerability of Ceftazidime-Avibactam Versus Meropenem in the Treatment of Nosocomial Pneumonia Including Ventilator-Associated Pneumonia in Hospitalized Adults

Arms:
arm 1: Intra-Venous treatment arm 2: Intra-Venous treatment

Interventions: intervention 1: ceftazidim-avibactam (CAZ-AVI, experimental product) intervention 2: meropenem (active comparator)
Intervention descriptions: intervention 1: 2000mg ceftazidime plus 500mg avibactam intervention 2: 1000mg of Meropenem

Protocol document: