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)
Information source: Merck Sharp & Dohme Corp.
ClinicalTrials.gov processed this data on August 23, 2015
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 Sharp & Dohme Corp. Official(s) and/or principal investigator(s):
Medical Monitor, Study Director, Affiliation: Merck Sharp & Dohme Corp.
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: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention
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. Goldstein EJ, Citron DM, Merriam CV, Abramson MA. Infection after elective colorectal surgery: bacteriological analysis of failures in a randomized trial of cefotetan vs. ertapenem prophylaxis. Surg Infect (Larchmt). 2009 Apr;10(2):111-8. doi: 10.1089/sur.2007.096. Itani KM, Wilson SE, Awad SS, Jensen EH, Finn TS, Abramson MA. Polyethylene glycol versus sodium phosphate mechanical bowel preparation in elective colorectal surgery. Am J Surg. 2007 Feb;193(2):190-4. Itani KM, Jensen EH, Finn TS, Tomassini JE, Abramson MA. Effect of body mass index and ertapenem versus cefotetan prophylaxis on surgical site infection in elective colorectal surgery. Surg Infect (Larchmt). 2008 Apr;9(2):131-7. doi: 10.1089/sur.2007.034.
Starting date: April 2002
Last updated: October 29, 2014
|
