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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|ClinicalTrials.gov Identifier: NCT00090272|
Recruitment Status : Completed
First Posted : August 27, 2004
Last Update Posted : February 17, 2017
|Condition or disease||Intervention/treatment||Phase|
|Colorectal Surgery||Drug: MK0826, ertapenem sodium Drug: Comparator: cefotetan||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||952 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|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 Start Date :||April 2002|
|Actual Primary Completion Date :||March 2005|
|Actual Study Completion Date :||March 2005|
- Surgical site infection following elective colorectal surgery based on surgical site assessment.
- Microbiology of surgical site infection in pts who fail prevention or have distant site infection; Safety profile based on AE monitoring and lab results.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00090272
|Study Director:||Medical Monitor||Merck Sharp & Dohme Corp.|