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)

Merck Sharp & Dohme LLC952 enrolled

Overview

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.

The duration of treatment is 1 day.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

952

Conditions

Colorectal Surgery

Interventions

MK0826, ertapenem sodiumDRUG

Comparator: cefotetanDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Surgical site infection following elective colorectal surgery based on surgical site assessment.

Secondary Outcomes

Microbiology of surgical site infection in pts who fail prevention or have distant site infection; Safety profile based on AE monitoring and lab results.

Data from ClinicalTrials.gov

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