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

December 3, 2010
October 16, 2012
December 2010
December 2011   (final data collection date for primary outcome measure)
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
Proportion 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 [ Time Frame: 4 weeks posttreatment ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01254344 on ClinicalTrials.gov Archive Site
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
Proportion of participants who have no signs or symptoms of infection at the surgical site and do not require surgical intervention for infection [ Time Frame: 4 weeks posttreatment ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Efficacy and Safety of Ertapenem Sodium (MK-0826) Following Colorectal Surgery in Chinese Adults (MK-0826-056)
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

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
  • Infection
  • Surgical Site Infection
  • 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: 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: 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
  • 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®
  • 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
    Interventions:
    • Drug: ertapenem sodium
    • Drug: placebo to metronidazole
  • 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
    Interventions:
    • Drug: ceftriaxone sodium
    • Drug: metronidazole
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
599
December 2011
December 2011   (final data collection date for primary outcome measure)

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.
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01254344
MK-0826-056
No
Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Not Provided
Not Provided
Merck Sharp & Dohme Corp.
October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP