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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01254344
First received: December 3, 2010
Last updated: October 16, 2012
Last verified: October 2012
  Purpose

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.


Condition Intervention Phase
Infection
Surgical Site Infection
Drug: ertapenem sodium
Drug: ceftriaxone sodium
Drug: placebo to metronidazole
Drug: metronidazole
Phase 3

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

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Percentage of Participants With Success of Prophylaxis [ Time Frame: From study drug dose (day of surgery) up to 4 weeks post therapy ] [ Designated as safety issue: No ]
    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:
  • Percentage of Participants With Favorable Clinical Response [ Time Frame: 4 weeks posttreatment ] [ Designated as safety issue: No ]
    Percentage of participants who have no signs or symptoms of infection at the surgical site and do not require surgical intervention for infection


Enrollment: 599
Study Start Date: December 2010
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ertapenem sodium 1 g
Ertapenem sodium 1 g administered intravenously (IV) as a single dose followed by matching placebo to metronidazole administered IV as a single dose
Drug: ertapenem sodium
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®
Drug: placebo to metronidazole
Placebo (0.9% sodium chloride) administered IV as a single dose over 30 minutes within 2 hours prior to the initial surgical incision
Active Comparator: Ceftriaxone sodium 2 g
Ceftriaxone sodium 2 g administered intravenously (IV) as a single dose followed by metronidazole 500 mg administered IV as a single dose
Drug: ceftriaxone sodium
Ceftriaxone sodium 2 g administered IV as a single dose over 30 minutes within 2 hours prior to the initial surgical incision
Other Name: Rocephin®
Drug: metronidazole
Metronidazole 500 mg administered IV as a single dose over 30 minutes within 2 hours prior to the initial surgical incision
Other Name: Flagyl®

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01254344     History of Changes
Other Study ID Numbers: MK-0826-056
Study First Received: December 3, 2010
Results First Received: October 16, 2012
Last Updated: October 16, 2012
Health Authority: China: Food and Drug Administration

Keywords provided by Merck Sharp & Dohme Corp.:
Colorectal surgery

Additional relevant MeSH terms:
Ceftriaxone
Ertapenem
Metronidazole
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antiprotozoal Agents
Antiparasitic Agents
Radiation-Sensitizing Agents

ClinicalTrials.gov processed this record on September 11, 2014