drugset / Trial / NCT01254344

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

NCT01254344

Phase 3 Completed 599 enrolled Merck Sharp & Dohme LLC
RandomizedParallel-groupQuadruple-blindPrevention

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.

Timeline

Start
2010-12
Primary completion
2011-12
Completion
2011-12

Drugs

EvaluationDrugModalityDoseRoute
Comparator Ceftriaxone Other / unclassified 2 g Intravenous
Subject Ertapenem Small molecule 1 g Intravenous
Comparator Metronidazole Small molecule 500 mg Intravenous

Indications