Efficacy and Safety of Ertapenem Sodium (MK-0826) Following Colorectal Surgery in Chinese Adults (MK-0826-056)

• Status: Completed
• Trial end date: 2011-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the efficacy and safety of ertapenem sodium compared with ceftriaxone sodium/metronidazole for the prophylaxis of surgical site infection following elective colorectal surgery in Chinese adults. This study is designed to demonstrate that ertapenem sodium is non-inferior to ceftriaxone sodium/metronidazole in this participant population.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Merck Sharp & Dohme Corp.
• Treatments: Ceftriaxone; Ertapenem; Metronidazole

Criteria

Inclusion Criteria:

• Participant is scheduled to undergo elective colon or colorectal surgery by

laparotomy that is scheduled in advance with adequate time prior to surgery to

complete preoperative bowel preparation.

• Participant is a Chinese adult between the ages of more than 18 years old and

less than 81 years old.

• Participant is highly unlikely to conceive.

Exclusion Criteria:

• Participant is undergoing emergency colon or colorectal surgery.

• Participant requires a second planned colorectal surgery or other surgery requiring antibiotic prophylaxis within the 4-week follow-up period.

• Participant is undergoing laparoscopic-assisted surgery.

• Participant is undergoing an isolated rectal procedure.

• Participant has a decompensated intestinal obstruction.

• Participant has active inflammatory bowel disease involving the colon (i.e.,

ulcerative colitis or Crohn's disease).

• Participant is scheduled to undergo an elective colorectal procedure for revision of a previous operation involving a large bowel resection.

• Participant has a bacterial infection at the time of surgery.

• Participant requires or is anticipated to need the administration of other (nonstudy therapy) systemic antimicrobial therapy within 1 week prior to surgery or at any time during this study.

• Participant is anticipated to receive either antibiotic or antiseptic peritoneal lavage during the surgery.

• Participant has a history of serious allergy, hypersensitivity (e.g., anaphylaxis), or any serious reaction to ertapenem sodium, ceftriaxone sodium, metronidazole, penicillin, or any cephalosporin, beta(β)-lactam, or nitroimidazole agents.

• Participant is breast feeding or plans to breast feed prior to the completion of the study period.

• Participant has neutropenia.

• Participant with immunosuppression due to an underlying disease, chronic

immunosuppressive therapy, or use of high-dose corticosteroids.

• Participant has a rapidly progressive or terminal illness.

• Participant is considered unlikely to survive through the expected 4-week study period.