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 (MSD)

Status and phase: Completed; Phase 3

Conditions: Colorectal Surgery

Treatments: Drug: MK0826, ertapenem sodium; Drug: Comparator: cefotetan

Study type: Interventional

Funder types: Industry

Identifiers

NCT00090272

2004_010

0826-039

Details and patient eligibility

About

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.

Full description

The duration of treatment is 1 day.

Enrollment: 952 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind