NCT01254344

Efficacy and Safety of Ertapenem Sodium (MK-0826) Following Colorectal Surgery in Chinese Adults (MK-0826-056)

A Phase III, Randomized, Double-Blind, Active Comparator-Controlled Clinical Trial to Study the Efficacy and Safety of Ertapenem Sodium (MK-0826) Versus Ceftriaxone Sodium/Metronidazole for the Prophylaxis of Surgical Site Infection Following Elective Colorectal Surgery in Chinese Adults

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 599 (actual)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Infection
• Surgical Site Infection

Interventions

Type	Name	Description
DRUG	ertapenem sodium	Ertapenem sodium 1 g administered IV as a single dose over 30 minutes within 2 hours prior to the initial surgical incision
DRUG	ceftriaxone sodium	Ceftriaxone sodium 2 g administered IV as a single dose over 30 minutes within 2 hours prior to the initial surgical incision
DRUG	placebo to metronidazole	Placebo (0.9% sodium chloride) administered IV as a single dose over 30 minutes within 2 hours prior to the initial surgical incision
DRUG	metronidazole	Metronidazole 500 mg administered IV as a single dose over 30 minutes within 2 hours prior to the initial surgical incision

Timeline

• Start date: 2010-12-01
• Primary completion: 2011-12-01
• Completion: 2011-12-01
• First posted: 2010-12-06
• Last updated: 2017-03-22
• Results posted: 2012-11-16