Back to resultsA 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)
Primary Purpose
Colorectal Surgery
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
MK0826, ertapenem sodium
Comparator: cefotetan
Sponsored by
About this trial
This is an interventional prevention trial for Colorectal Surgery
Eligibility 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
Sites / Locations
Outcomes
Primary Outcome Measures
Surgical site infection following elective colorectal surgery based on surgical site assessment.
Secondary Outcome Measures
Microbiology of surgical site infection in pts who fail prevention or have distant site infection; Safety profile based on AE monitoring and lab results.
Full Information
NCT ID
NCT00090272
First Posted
August 25, 2004
Last Updated
February 16, 2017
Sponsor
Merck Sharp & Dohme LLC
1. Study Identification
Unique Protocol Identification Number
NCT00090272
Brief Title
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)
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 Type
Interventional
2. Study Status
Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
April 2002 (undefined)
Primary Completion Date
March 2005 (Actual)
Study Completion Date
March 2005 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Merck Sharp & Dohme LLC
4. Oversight
5. Study Description
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.
Detailed Description
The duration of treatment is 1 day.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Surgery
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
952 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
MK0826, ertapenem sodium
Intervention Type
Drug
Intervention Name(s)
Comparator: cefotetan
Primary Outcome Measure Information:
Title
Surgical site infection following elective colorectal surgery based on surgical site assessment.
Secondary Outcome Measure Information:
Title
Microbiology of surgical site infection in pts who fail prevention or have distant site infection; Safety profile based on AE monitoring and lab results.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Monitor
Organizational Affiliation
Merck Sharp & Dohme LLC
Official's Role
Study Director
12. IPD Sharing Statement
Citations:
PubMed Identifier
17182989
Citation
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.
Results Reference
background
PubMed Identifier
19226203
Citation
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.
Results Reference
background
PubMed Identifier
17236845
Citation
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. doi: 10.1016/j.amjsurg.2006.08.024.
Results Reference
background
PubMed Identifier
18426345
Citation
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.
Results Reference
background
Available IPD and Supporting Information:
Available IPD/Information Type
CSR Synopsis
Available IPD/Information URL
http://www.merck.com/clinical-trials/policies-perspectives.html
Learn more about this trial
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)
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