Conditions: Complicated Intra-abdominal Infection
Keywords: Ceftazidime-avibactam, Metronidazole, Meropenem, Anti-Bacterial Agents, Anti-Infective Agents, Therapeutic Uses, Pharmacologic Actions, Physiological Effects of Drugs
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 486
Healthy volunteers: no

Brief summary:
The purpose of this study is to evaluate the effects of Ceftazidime Avibactam plus Metronidazole compared to Meropenem for treating hospitalized patients with complicated intra-abdominal infections.

Detailed description:
A Phase III, Randomized, Multicenter, Double Blind, Double-Dummy, Parallel-Group, Comparative Study to Determine the Efficacy, Safety, and Tolerability of Ceftazidime Avibactam Plus Metronidazole Versus Meropenem in the Treatment of Complicated Intra-Abdominal Infections In Hospitalized Adults

Arms:
arm 1: None arm 2: None

Interventions: intervention 1: Ceftazidime-avibactam intervention 2: metronidazole intervention 3: Meropenem
Intervention descriptions: intervention 1: Ceftazidime-Avibactam powder for concentrate for solution for infusion 2000 mg/500 mg intervention 2: Metronidazole 500mg/100ml solution for infusion intervention 3: Meropenem powder for solution for infusion 1000mg

Protocol document: