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

This study has been completed.

Sponsored by:	Merck
Information provided by:	Merck
ClinicalTrials.gov Identifier:	NCT00090272

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 III

MedlinePlus related topics: Dietary Sodium

Drug Information available for: Ertapenem L 749345 Cefotetan Cefotetan disodium

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
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

Further study details as provided by Merck:

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.

Estimated Enrollment:	900
Study Start Date:	April 2002

Detailed Description:

The duration of treatment is 1 day.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00090272

Sponsors and Collaborators

Merck

Investigators

Study Director:

Medical Monitor

Merck

More Information

Publications:

Itani KM, Wilson SE, Awad SS, Jensen EH, Finn TS, Abramson MA. Ertapenem versus cefotetan prophylaxis in elective colorectal surgery. N Engl J Med. 2006 Dec 21;355(25):2640-51.

Study ID Numbers:	2004_010
Study First Received:	August 25, 2004
Last Updated:	October 8, 2007
ClinicalTrials.gov Identifier:	NCT00090272
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Ertapenem
Cefotetan

Additional relevant MeSH terms:

Anti-Infective Agents
Anti-Bacterial Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009