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

NCT01254344 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 599

Last updated 2017-03-22

Study results available
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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

Interventions

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

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-12-31
Primary Completion
2011-12-31
Completion
2011-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01254344 on ClinicalTrials.gov