Conditions: Infection Surgical Site Infection
Keywords: Colorectal surgery
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 599
Healthy volunteers: no

Brief summary:
The purpose of this study is to evaluate the efficacy and safety of ertapenem sodium compared with ceftriaxone sodium/metronidazole for the prophylaxis of surgical site infection following elective colorectal surgery in Chinese adults. This study is designed to demonstrate that ertapenem sodium is non-inferior to ceftriaxone sodium/metronidazole in this participant population.

Detailed description:

Arms:
arm 1: Ertapenem sodium 1 g administered intravenously (IV) as a single dose followed by matching placebo to metronidazole administered IV as a single dose arm 2: Ceftriaxone sodium 2 g administered intravenously (IV) as a single dose followed by metronidazole 500 mg administered IV as a single dose

Interventions: intervention 1: ertapenem sodium intervention 2: ceftriaxone sodium intervention 3: placebo to metronidazole intervention 4: metronidazole
Intervention descriptions: intervention 1: Ertapenem sodium 1 g administered IV as a single dose over 30 minutes within 2 hours prior to the initial surgical incision intervention 2: Ceftriaxone sodium 2 g administered IV as a single dose over 30 minutes within 2 hours prior to the initial surgical incision intervention 3: Placebo (0.9% sodium chloride) administered IV as a single dose over 30 minutes within 2 hours prior to the initial surgical incision intervention 4: Metronidazole 500 mg administered IV as a single dose over 30 minutes within 2 hours prior to the initial surgical incision

Protocol document: