CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 599 enrolled
Drug / intervention
ertapenem sodium +3 moredrug
Likely dose
ertapenem sodium 1 gfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01254344
NCT01254344Phase 3Completed
CompareCT.gov

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

Merck Sharp & Dohme LLC·interventional·Posted Dec 6, 2010·Updated Mar 22, 2017

In Brief

A Phase 3 clinical trial evaluating ertapenem sodium, ceftriaxone sodium, and 2 other interventions for Infection and Surgical Site Infection. Completed, enrolled 599 participants.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsInfection, Surgical Site Infection
Countries--
Collaborators--

Timeline

Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedDec 6, 2010
Enrollment StartDec 1, 2010
Primary CompletionDec 1, 2011
TodayJul 2, 2026
Enrollment to primary: 1 yearPosted 15.6 years ago

Interventions

ertapenem sodiumdrug

Ertapenem sodium 1 g administered IV as a single dose over 30 minutes within 2 hours prior to the initial surgical incision

ceftriaxone sodiumdrug

Ceftriaxone sodium 2 g administered IV as a single dose over 30 minutes within 2 hours prior to the initial surgical incision

placebo to metronidazoledrug

Placebo (0.9% sodium chloride) administered IV as a single dose over 30 minutes within 2 hours prior to the initial surgical incision

metronidazoledrug

Metronidazole 500 mg administered IV as a single dose over 30 minutes within 2 hours prior to the initial surgical incision