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Sponsored by: |
Merck |
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Information provided by: | Merck |
ClinicalTrials.gov Identifier: | NCT00090272 |
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 |
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Colorectal Surgery |
Drug: MK0826, ertapenem sodium Drug: Comparator: cefotetan |
Phase III |
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 |
Estimated Enrollment: | 900 |
Study Start Date: | April 2002 |
The duration of treatment is 1 day.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
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:
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 |
Ertapenem Cefotetan |
Anti-Infective Agents Anti-Bacterial Agents Therapeutic Uses Pharmacologic Actions |