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

Information source: Merck Sharp & Dohme Corp.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Infection; Surgical Site Infection

Intervention: ertapenem sodium (Drug); ceftriaxone sodium (Drug); placebo to metronidazole (Drug); metronidazole (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Merck Sharp & Dohme Corp.


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.

Clinical Details

Official title: A Phase III, Randomized, Double-Blind, Active Comparator-Controlled Clinical Trial to Study the Efficacy and Safety of Ertapenem Sodium (MK-0826) Versus Ceftriaxone Sodium/Metronidazole for the Prophylaxis of Surgical Site Infection Following Elective Colorectal Surgery in Chinese Adults

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Primary outcome: Percentage of Participants With Success of Prophylaxis

Secondary outcome: Percentage of Participants With Favorable Clinical Response


Minimum age: 18 Years. Maximum age: 80 Years. Gender(s): Both.


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


Locations and Contacts

Additional Information

Starting date: December 2010
Last updated: June 8, 2015

Page last updated: August 23, 2015

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