A Prospective, Multicenter, Double-Blind, Randomized, Comparative Study to Evaluate the Safety, Tolerability, and Efficacy of a Single Dose of Ertapenem Sodium (MK0826) Versus Cefotetan for the Prophylaxis of Surgical Site Infection Following Elective Colorectal Surgery

Merck Sharp & Dohme LLC0 sites952 target enrollmentApril 2002

ConditionsColorectal Surgery

DrugsMK0826, ertapenem sodium Comparator: cefotetan

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Colorectal Surgery
Sponsor: Merck Sharp & Dohme LLC
Enrollment: 952
Primary Endpoint: Surgical site infection following elective colorectal surgery based on surgical site assessment.
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

The objective of this study is to evaluate the safety and efficacy of a one time dose of an intravenous marketed drug being evaluated for a new indication as compared to a marketed drug already approved for the prevention of surgical site infection following colorectal surgery.

Detailed Description

The duration of treatment is 1 day.

Registry

clinicaltrials.gov

Start Date

April 2002

End Date

March 2005

Last Updated

9 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Merck Sharp & Dohme LLC

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Male or female patients 18 years of age scheduled to undergo elective colon or colorectal surgery by laparotomy must meet the following criteria:
•Surgery must be scheduled in advance.
•There must be adequate time to complete preoperative bowel preparation

Exclusion Criteria

Not provided

Outcomes

Primary Outcomes

Surgical site infection following elective colorectal surgery based on surgical site assessment.

Secondary Outcomes

Microbiology of surgical site infection in pts who fail prevention or have distant site infection; Safety profile based on AE monitoring and lab results.