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Ertapenem Sodium vs. Piperacillin/Tazobactam in the Treatment of Complicated Intra-Abdominal Infections (0826-037)

Primary Purpose

Complicated Intra-Abdominal Infections

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
MK0826, /Duration of Treatment : 8 Weeks
Comparator : piperacillin sodium (+) tazobactam sodium /Duration of Treatment : 8 Weeks
Sponsored by
Merck Sharp & Dohme LLC
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Complicated Intra-Abdominal Infections

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Male or female patients (greater or equal to 18 years of age)
  • Intraoperative/Postoperative Enrollment: Upon visual confirmation of an intra-abdominal infection.
  • Preoperative Enrollment: Patients may be enrolled preoperatively if they meet certain criteria

Exclusion Criteria:

  • Failure to meet all inclusion criteria.
  • Patients who are considered unlikely to survive the 6-8 week study period.
  • Pregnant or nursing women, or fertile women not practicing adequate methods of contraception.

Sites / Locations

    Outcomes

    Primary Outcome Measures

    In microbiologically evaluable patients, ertapenem will be at least as effective as piperacillin/tazobactam at the 2-weeks post-treatment Early Follow-up Assessment.

    Secondary Outcome Measures

    In microbiologically evaluable patients, ertapenem will be at least as effective as piperacillin/tazobactam at the 4-6 weeks post-treatment Late Follow-up Assessment.

    Full Information

    First Posted
    October 18, 2006
    Last Updated
    February 16, 2017
    Sponsor
    Merck Sharp & Dohme LLC
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00389987
    Brief Title
    Ertapenem Sodium vs. Piperacillin/Tazobactam in the Treatment of Complicated Intra-Abdominal Infections (0826-037)
    Official Title
    A Prospective, Multicenter, Double-Blind With In-House Blinding, Randomized, Comparative Study to Evaluate the Efficacy, Safety, and Tolerability of Ertapenem Sodium Versus Piperacillin/Tazobactam in the Treatment of Complicated Intra-Abdominal Infections in Hospitalized Adults
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    September 2001 (undefined)
    Primary Completion Date
    May 2004 (Actual)
    Study Completion Date
    May 2004 (Actual)

    3. Sponsor/Collaborators

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

    4. Oversight

    5. Study Description

    Brief Summary
    This study is designed to compare the efficacy of ertapenem and piperacillin/tazobactam with respect to the clinical response in baseline microbiologically evaluable patients; and to evaluate the tolerability and safety of ertapenem compared to piperacillin/tazobactam.
    Detailed Description
    Original label approved November 2001

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Complicated Intra-Abdominal Infections

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    Double
    Allocation
    Randomized
    Enrollment
    300 (false)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    MK0826, /Duration of Treatment : 8 Weeks
    Intervention Type
    Drug
    Intervention Name(s)
    Comparator : piperacillin sodium (+) tazobactam sodium /Duration of Treatment : 8 Weeks
    Primary Outcome Measure Information:
    Title
    In microbiologically evaluable patients, ertapenem will be at least as effective as piperacillin/tazobactam at the 2-weeks post-treatment Early Follow-up Assessment.
    Time Frame
    2-weeks post-treatment
    Secondary Outcome Measure Information:
    Title
    In microbiologically evaluable patients, ertapenem will be at least as effective as piperacillin/tazobactam at the 4-6 weeks post-treatment Late Follow-up Assessment.
    Time Frame
    4-6 Weeks post-treatment

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Male or female patients (greater or equal to 18 years of age) Intraoperative/Postoperative Enrollment: Upon visual confirmation of an intra-abdominal infection. Preoperative Enrollment: Patients may be enrolled preoperatively if they meet certain criteria Exclusion Criteria: Failure to meet all inclusion criteria. Patients who are considered unlikely to survive the 6-8 week study period. Pregnant or nursing women, or fertile women not practicing adequate methods of contraception.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Medical Monitor
    Organizational Affiliation
    Merck Sharp & Dohme LLC
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    17381394
    Citation
    Namias N, Solomkin JS, Jensen EH, Tomassini JE, Abramson MA. Randomized, multicenter, double-blind study of efficacy, safety, and tolerability of intravenous ertapenem versus piperacillin/tazobactam in treatment of complicated intra-abdominal infections in hospitalized adults. Surg Infect (Larchmt). 2007 Feb;8(1):15-28. doi: 10.1089/sur.2006.030.
    Results Reference
    background
    Available IPD and Supporting Information:
    Available IPD/Information Type
    CSR Synopsis
    Available IPD/Information URL
    http://www.merck.com/clinical-trials/policies-perspectives.html

    Learn more about this trial

    Ertapenem Sodium vs. Piperacillin/Tazobactam in the Treatment of Complicated Intra-Abdominal Infections (0826-037)

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