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
Information source: Merck
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Colorectal Surgery
Intervention: MK0826, ertapenem sodium (Drug); Comparator: cefotetan (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Merck Official(s) and/or principal investigator(s):
Medical Monitor, Study Director, Affiliation: Merck
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.
Clinical Details
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 design: Prevention, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Surgical site infection following elective colorectal surgery based on surgical site assessment.
Secondary outcome: Microbiology of surgical site infection in pts who fail prevention or have distant site infection; Safety profile based on AE monitoring and lab results.
Detailed description:
The duration of treatment is 1 day.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Additional Information
Related 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.
Starting date: April 2002
Last updated: October 8, 2007
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