At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 952 enrolled
Drug / intervention
MK0826, ertapenem sodium +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 3 clinical trial evaluating MK0826, ertapenem sodium and Comparator: cefotetan for Colorectal Surgery. Completed, enrolled 952 participants.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsColorectal Surgery
Countries--
Collaborators--
Timeline
Phase 3CompletedFinished
20022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartApr 2002
First PostedAug 2004
Primary CompletionMar 2005
TodayJul 2026
First PostedAug 27, 2004
Enrollment StartApr 1, 2002
Primary CompletionMar 1, 2005
TodayJul 2, 2026
Enrollment to primary: 2.9 yearsPosted 21.8 years ago
Interventions
MK0826, ertapenem sodiumdrug
Comparator: cefotetandrug