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)
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
2 other identifiers
interventional
952
0 countries
N/A
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Apr 2002
Typical duration for phase_3
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2002
CompletedFirst Submitted
Initial submission to the registry
August 25, 2004
CompletedFirst Posted
Study publicly available on registry
August 27, 2004
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2005
CompletedFebruary 17, 2017
February 1, 2017
2.9 years
August 25, 2004
February 16, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Surgical site infection following elective colorectal surgery based on surgical site assessment.
Secondary Outcomes (1)
Microbiology of surgical site infection in pts who fail prevention or have distant site infection; Safety profile based on AE monitoring and lab results.
Interventions
Eligibility Criteria
You may qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (4)
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. doi: 10.1056/NEJMoa054408.
PMID: 17182989BACKGROUNDGoldstein 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.
PMID: 19226203BACKGROUNDItani 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. doi: 10.1016/j.amjsurg.2006.08.024.
PMID: 17236845BACKGROUNDItani 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.
PMID: 18426345BACKGROUND
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Medical Monitor
Merck Sharp & Dohme LLC
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 25, 2004
First Posted
August 27, 2004
Study Start
April 1, 2002
Primary Completion
March 1, 2005
Study Completion
March 1, 2005
Last Updated
February 17, 2017
Record last verified: 2017-02