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

Primary Purpose

Infection, Surgical Site Infection

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
ertapenem sodium
ceftriaxone sodium
placebo to metronidazole
metronidazole
Sponsored by
Merck Sharp & Dohme LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Infection focused on measuring Colorectal surgery

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Ertapenem sodium 1 g

    Ceftriaxone sodium 2 g

    Arm Description

    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 administered intravenously (IV) as a single dose followed by metronidazole 500 mg administered IV as a single dose

    Outcomes

    Primary Outcome Measures

    Percentage of Participants With Success of Prophylaxis
    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
    Percentage of participants who have no signs or symptoms of infection at the surgical site and do not require surgical intervention for infection

    Full Information

    First Posted
    December 3, 2010
    Last Updated
    February 17, 2017
    Sponsor
    Merck Sharp & Dohme LLC
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01254344
    Brief Title
    Efficacy and Safety of Ertapenem Sodium (MK-0826) Following Colorectal Surgery in Chinese Adults (MK-0826-056)
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    December 2010 (undefined)
    Primary Completion Date
    December 2011 (Actual)
    Study Completion Date
    December 2011 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Merck Sharp & Dohme LLC

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Infection, Surgical Site Infection
    Keywords
    Colorectal surgery

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    599 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Ertapenem sodium 1 g
    Arm Type
    Experimental
    Arm Description
    Ertapenem sodium 1 g administered intravenously (IV) as a single dose followed by matching placebo to metronidazole administered IV as a single dose
    Arm Title
    Ceftriaxone sodium 2 g
    Arm Type
    Active Comparator
    Arm Description
    Ceftriaxone sodium 2 g administered intravenously (IV) as a single dose followed by metronidazole 500 mg administered IV as a single dose
    Intervention Type
    Drug
    Intervention Name(s)
    ertapenem sodium
    Other Intervention Name(s)
    MK-0826, INVANZ®
    Intervention Description
    Ertapenem sodium 1 g administered IV as a single dose over 30 minutes within 2 hours prior to the initial surgical incision
    Intervention Type
    Drug
    Intervention Name(s)
    ceftriaxone sodium
    Other Intervention Name(s)
    Rocephin®
    Intervention Description
    Ceftriaxone sodium 2 g administered IV as a single dose over 30 minutes within 2 hours prior to the initial surgical incision
    Intervention Type
    Drug
    Intervention Name(s)
    placebo to metronidazole
    Intervention Description
    Placebo (0.9% sodium chloride) administered IV as a single dose over 30 minutes within 2 hours prior to the initial surgical incision
    Intervention Type
    Drug
    Intervention Name(s)
    metronidazole
    Other Intervention Name(s)
    Flagyl®
    Intervention Description
    Metronidazole 500 mg administered IV as a single dose over 30 minutes within 2 hours prior to the initial surgical incision
    Primary Outcome Measure Information:
    Title
    Percentage of Participants With Success of Prophylaxis
    Description
    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
    Time Frame
    From study drug dose (day of surgery) up to 4 weeks post therapy
    Secondary Outcome Measure Information:
    Title
    Percentage of Participants With Favorable Clinical Response
    Description
    Percentage 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

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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.

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Plan Description
    http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final_Updated%20July_9_2014.pdf http://engagezone.msd.com/ds_documentation.php
    Citations:
    PubMed Identifier
    25151205
    Citation
    Leng XS, Zhao YJ, Qiu HZ, Cao YK, Zhu WH, Shen JF, Paschke A, Dai WM, Caldwell N, Wang J. Ertapenem prophylaxis of surgical site infections in elective colorectal surgery in China: a multicentre, randomized, double-blind, active-controlled study. J Antimicrob Chemother. 2014 Dec;69(12):3379-86. doi: 10.1093/jac/dku302. Epub 2014 Aug 23.
    Results Reference
    result

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

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