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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)

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ClinicalTrials.gov Identifier: NCT00090272
Recruitment Status : Completed
First Posted : August 27, 2004
Last Update Posted : February 17, 2017
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

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.

Condition or disease Intervention/treatment Phase
Colorectal Surgery Drug: MK0826, ertapenem sodium Drug: Comparator: cefotetan Phase 3

Detailed Description:
The duration of treatment is 1 day.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 952 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: 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
Study Start Date : April 2002
Actual Primary Completion Date : March 2005
Actual Study Completion Date : March 2005

Resource links provided by the National Library of Medicine

U.S. FDA Resources




Primary Outcome Measures :
  1. Surgical site infection following elective colorectal surgery based on surgical site assessment.

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


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00090272


Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Monitor Merck Sharp & Dohme Corp.