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
Sponsored by: Merck
Official(s) and/or principal investigator(s):
Medical Monitor, Study Director, Affiliation: Merck
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.
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.
The duration of treatment is 1 day.
Minimum age: 18 Years.
Maximum age: N/A.
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
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