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

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 3

Conditions: Infection; Surgical Site Infection

Treatments: Drug: placebo to metronidazole; Drug: ertapenem sodium; Drug: metronidazole; Drug: ceftriaxone sodium

Study type: Interventional

Funder types: Industry

Identifiers

NCT01254344

0826-056

Details and patient eligibility

About

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.

Enrollment: 599 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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599 participants in 2 patient groups

Ertapenem sodium 1 g

Experimental group

Description:

Ertapenem sodium 1 g administered intravenously (IV) as a single dose followed by matching placebo to metronidazole administered IV as a single dose

Treatment:

Drug: ertapenem sodium

Drug: placebo to metronidazole

Ceftriaxone sodium 2 g

Active Comparator group

Description:

Ceftriaxone sodium 2 g administered intravenously (IV) as a single dose followed by metronidazole 500 mg administered IV as a single dose

Treatment:

Drug: metronidazole

Drug: ceftriaxone sodium