Conditions: Intra-abdominal Infection
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 470
Healthy volunteers: no

Brief summary:
This is a comparative study of the efficacy and safety of tigecycline to imipenem/cilastatin in hospitalized patients with a complicated intra-abdominal infection.

Detailed description:

Arms:
arm 1: None arm 2: None

Interventions: intervention 1: Tigecycline intervention 2: Imipenem/cilastatin
Intervention descriptions: intervention 1: every 12 hours (an initial intravenous dose of 100 mg followed by 50 mg twice a day approximately every 12 hours) and placebo intravenous doses every 12 hours beginning 6 hours after the initial intravenous dose of tigecycline for at least for 5 days and up to 14 days. intervention 2: every 6 hours intravenously, and the imipenem/cilastatin will be dosed by 500mg/500mg for the subjects with creatinine clearance equal or above 71ml/min/1.73m2 or dose will be adjusted by Schedule of Study Drug Administration for Subjects with Renal Impairment.

Protocol document: