Efficacy and Safety of Ertapenem Sodium (MK-0826) Following Colorectal Surgery in Chinese Adults (MK-0826-056)
Condition: Infection; Surgical Site Infection
MeSH terms: Infections; Communicable Diseases; Surgical Wound Infection
Intervention: ertapenem sodium; ceftriaxone sodium; placebo to metronidazole; metronidazole
Intervention description: Ertapenem sodium 1 g administered IV as a single dose over 30 minutes within 2 hours prior to the initial surgical incision; Ceftriaxone sodium 2 g administered IV as a single dose over 30 minutes within 2 hours prior to the initial surgical incision; Placebo (0.9% sodium chloride) administered IV as a single dose over 30 minutes within 2 hours prior to the initial surgical incision; Metronidazole 500 mg administered IV as a single dose over 30 minutes within 2 hours prior to the initial surgical incision
Intervention MeSH terms: Metronidazole; Ceftriaxone; Ertapenem
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 599.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Colorectal surgery

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.
    

Eligibility 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.