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Completed

NCT Number: NCT01254344

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

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.

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Key information

Conditions

Infection Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Surgical Site Infection Surgical Wound Infection Wound Infection

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ertapenem sodium

Drug

Ertapenem sodium 1 g administered IV as a single dose over 30 minutes within 2 hours prior to the initial surgical incision

Other names: MK-0826, INVANZ®

ceftriaxone sodium

Drug

Ceftriaxone sodium 2 g administered IV as a single dose over 30 minutes within 2 hours prior to the initial surgical incision

Other names: Rocephin®

placebo to metronidazole

Drug

Placebo (0.9% sodium chloride) administered IV as a single dose over 30 minutes within 2 hours prior to the initial surgical incision

Metronidazole

Drug

Metronidazole 500 mg administered IV as a single dose over 30 minutes within 2 hours prior to the initial surgical incision

Other names: Flagyl®

Primary outcomes

  1. Percentage of Participants With Success of Prophylaxis

    Time frame: 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 outcomes

  1. Percentage of Participants With Favorable Clinical Response

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study 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

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Dec 6, 2010
Registry last updated
Mar 22, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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