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

Phase 3

Completed

• Conditions: Infection; Surgical Site Infection
• Interventions: Drug: ertapenem sodium; Drug: ceftriaxone sodium; Drug: placebo to metronidazole; Drug: metronidazole

• Registration Number: NCT01254344
• Lead Sponsor: Merck Sharp & Dohme LLC

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-12
• Study First Submitted: 2010-12-03
• Study First Submitted QC: 2010-12-03
• Study First Posted: 2010-12-06
• Primary Completion: 2011-12
• Study Completion: 2011-12
• Results First Submitted: 2012-10-16
• Results First Submitted QC: 2012-10-16
• Results First Posted: 2012-11-16
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-17
• Last Update Posted: 2017-03-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 599

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ertapenem sodium 1 g	ertapenem sodium	Ertapenem sodium 1 g administered intravenously (IV) as a single dose followed by matching placebo to metronidazole administered IV as a single dose
Ertapenem sodium 1 g	placebo to metronidazole	Ertapenem sodium 1 g administered intravenously (IV) as a single dose followed by matching placebo to metronidazole administered IV as a single dose
Ceftriaxone sodium 2 g	ceftriaxone sodium	Ceftriaxone sodium 2 g administered intravenously (IV) as a single dose followed by metronidazole 500 mg administered IV as a single dose
Ceftriaxone sodium 2 g	metronidazole	Ceftriaxone sodium 2 g administered intravenously (IV) as a single dose followed by metronidazole 500 mg administered IV as a single dose

Primary Outcome Measures

Name	Time	Method
Percentage of Participants With Success of Prophylaxis	From study drug dose (day of surgery) up to 4 weeks post therapy	Percentage of participants who have no signs or symptoms of infection at the surgical site, do not require surgical intervention for infection, and have no need for further antimicrobial therapy

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants With Favorable Clinical Response	4 weeks posttreatment	Percentage of participants who have no signs or symptoms of infection at the surgical site and do not require surgical intervention for infection