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

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

Outcome

Met primary endpoint

paper The difference in the proportion of successful outcomes was 0.1% (95% CI -5.2%, 5.5%). PMID 25151205 ↗

paper CONCLUSIONS: Ertapenem is as effective as ceftriaxone/metronidazole for SSI prophylaxis in patients undergoing elective colorectal surgery, and is well tolerated. PMID 25151205 ↗

Publications

• Results Leng XS, Zhao YJ, Qiu HZ, Cao YK, Zhu WH, Shen JF, Paschke A, Dai WM, Caldwell N, Wang J. Ertapenem prophylaxis of surgical site infections in elective colorectal surgery in China: a multicentre, randomized, double-blind, active-controlled study. J Antimicrob Chemother. 2014 Dec;69(12):3379-86. doi: 10.1093/jac/dku302. Epub 2014 Aug 23.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Ceftriaxone	Other / unclassified	2 g	Intravenous
Subject	Ertapenem	Small molecule	1 g	Intravenous
Comparator	Metronidazole	Small molecule	500 mg	Intravenous

Indications