Conditions: Complicated Intra-abdominal Infections
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 541
Healthy volunteers: no

Brief summary:
This is a Phase 3, randomized, double-blind, double-dummy, multicenter, prospective study to assess the efficacy, safety, and pharmacokinetics of eravacycline compared with ertapenem in the treatment of adult complicated intra-abdominal infections (cIAI).

Detailed description:

Arms:
arm 1: Eravacycline was administered intravenously (IV) at a dose of 1.0 milligram per kilogram of body weight (mg/kg) every 12 hours (q12h) for a minimum of 4 days and a maximum of 14 days. Eravacycline treatment was to be stopped when symptoms of complicated intra-abdominal infection (cIAI) resolved, there was treatment failure, or the maximum allowed number of infusion days was reached. arm 2: Ertapenem was administered IV at a dose of 1.0 gram (g) every 24 hours (q24h) for a minimum of 4 days and a maximum of 14 days. Ertapenem treatment was to be stopped when symptoms of cIAI resolved, there was treatment failure, or the maximum allowed number of infusion days was reached.

Interventions: intervention 1: Eravacycline intervention 2: Ertapenem intervention 3: Placebo
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: Administered IV to maintain the blind.

Protocol document: