A Single Dose of a Marketed Drug Being Studied for a New Indication to Treat Surgical Site Infection Following Colorectal Surgery as Compared to a Marketed Drug Approved for This Indication (0826-039)

Phase 3

Completed

• Conditions: Colorectal Surgery

• Registration Number: NCT00090272
• Lead Sponsor: Merck Sharp & Dohme LLC

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.

Study Timeline

• Study Start: 2002-04
• Study First Submitted: 2004-08-25
• Study First Submitted QC: 2004-08-26
• Study First Posted: 2004-08-27
• Primary Completion: 2005-03
• Study Completion: 2005-03
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-16
• Last Update Posted: 2017-02-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 952

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

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

Secondary Outcome Measures

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