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)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

952 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-04-30

Study Completion Date

2005-03-31

Brief Summary

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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.

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Detailed Description

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The duration of treatment is 1 day.

Conditions

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Colorectal Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Interventions

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MK0826, ertapenem sodium

Intervention Type DRUG

Comparator: cefotetan

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No