Who is sponsoring NCT01254344?

NCT01254344 is sponsored by Merck Sharp & Dohme LLC.

What condition does NCT01254344 study?

NCT01254344 studies Infection, Surgical Site Infection.

What drugs are being tested in NCT01254344?

Interventions: ertapenem sodium, ceftriaxone sodium, placebo to metronidazole, metronidazole.

What is the status of NCT01254344?

NCT01254344 is currently COMPLETED.

Last reviewed 2017-02-17 · How we verify

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

NCT01254344 Phase 3 COMPLETED Results posted

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.

Details

Lead sponsor	Merck Sharp & Dohme LLC
Phase	Phase 3
Status	COMPLETED
Enrolment	599
Start date	2010-12
Completion	2011-12

Conditions

Infection
Surgical Site Infection

Interventions

ertapenem sodium
ceftriaxone sodium
placebo to metronidazole
metronidazole

Primary outcomes

Percentage of Participants With Success of Prophylaxis — From study drug dose (day of surgery) up to 4 weeks post therapy
Percentage of participants who have no signs or symptoms of infection at the surgical site, do not require surgical intervention for infection, and have no need for further antimicrobial therapy