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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)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00090272
First Posted: August 27, 2004
Last Update Posted: February 17, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
  Purpose
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 Intervention Phase
Colorectal Surgery Drug: MK0826, ertapenem sodium Drug: Comparator: cefotetan Phase 3

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

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

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

Enrollment: 952
Study Start Date: April 2002
Study Completion Date: March 2005
Primary Completion Date: March 2005 (Final data collection date for primary outcome measure)
Detailed Description:
The duration of treatment is 1 day.
  Eligibility

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
  Contacts and Locations
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.