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Safety and Tolerability of Ertapenem Sodium in the Treatment of Complicated Urinary Tract Infections (0826-055)

Primary Purpose

Urinary Tract Infection

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
ertapenem sodium (MK0826)
Comparator: ceftriaxone sodium
Sponsored by
Merck Sharp & Dohme LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Urinary Tract Infection

Eligibility Criteria

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

Inclusion Criteria:

  • Adult patients with a suspected or documented complicated urinary tract infection
  • Female patients must test negative for pregnancy and agree to use adequate birth control measures
  • Nursing women must agree to defer breastfeeding until 5 days after completion of all study antibiotic therapy

Exclusion Criteria:

  • Patients with complete obstruction of any portion of the urinary tract
  • Patients with rapidly progressive or terminal illness
  • Renal transplant patients

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    ertapenem sodium (MK0826)

    ceftriaxone sodium

    Arm Description

    ertapenem sodium

    ceftriaxone sodium

    Outcomes

    Primary Outcome Measures

    Microbiological Response Assessment Profile
    The difference in favorable microbiological response rates between the 2 treatment groups (MK0826 response rate minus ceftriaxone response rate) was assessed
    The Number of Patients Who Experience Any Drug-related Adverse Experiences Leading to Discontinuation of Parenteral Study Drug and the Number of Patients With Any Drug-related Serious Adverse Experiences (AEs) During Parenteral Treatment
    Safety was assessed by statistical and/or clinical review of all safety parameters, including adverse experiences, physical examination, vital signs, and laboratory results during parenteral therapy. As per the primary safety hypothesis, it was expected that, at the end of the parenteral therapy only, MK0826 would be similar to ceftriaxone with respect to the proportion of patients with any drug-related clinical or laboratory adverse experiences leading to discontinuation of study drug and also with respect to the proportion of patients with any serious drug-related adverse experiences.

    Secondary Outcome Measures

    Clinical Response Assessment Profile
    The difference in favorable clinical response rates between the 2 treatment groups (MK0826 response rate minus ceftriaxone response rate) was assessed

    Full Information

    First Posted
    November 12, 2009
    Last Updated
    February 16, 2017
    Sponsor
    Merck Sharp & Dohme LLC
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01014013
    Brief Title
    Safety and Tolerability of Ertapenem Sodium in the Treatment of Complicated Urinary Tract Infections (0826-055)
    Official Title
    A Prospective, Multicenter, Partially-Blinded, Randomized, Comparative Study to Evaluate the Safety, Tolerability and Efficacy of INVANZ Versus Ceftriaxone Sodium in the Treatment of Complicated Urinary Tract Infections in Adults
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    April 2008 (undefined)
    Primary Completion Date
    February 2009 (Actual)
    Study Completion Date
    February 2009 (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 determine the efficacy of ertapenem sodium (Invanz) in treatment of complicated urinary tract infections with respect to the proportion of patients with a favorable microbiological response at 5-9 days post therapy.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Urinary Tract Infection

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    271 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    ertapenem sodium (MK0826)
    Arm Type
    Experimental
    Arm Description
    ertapenem sodium
    Arm Title
    ceftriaxone sodium
    Arm Type
    Active Comparator
    Arm Description
    ceftriaxone sodium
    Intervention Type
    Drug
    Intervention Name(s)
    ertapenem sodium (MK0826)
    Other Intervention Name(s)
    MK0826
    Intervention Description
    a single daily dose of ertapenem sodium 1.0g IV infused over 30 minutes, for 7-14 days (patients may be switched to oral ciprofloxacin after 3 doses of IV therapy if needed)
    Intervention Type
    Drug
    Intervention Name(s)
    Comparator: ceftriaxone sodium
    Intervention Description
    a single daily dose of ceftriaxone 2.0g IV infused over 30 minutes, for 7-14 days (patients may be switched to oral ciprofloxacin after 3 doses of IV therapy)
    Primary Outcome Measure Information:
    Title
    Microbiological Response Assessment Profile
    Description
    The difference in favorable microbiological response rates between the 2 treatment groups (MK0826 response rate minus ceftriaxone response rate) was assessed
    Time Frame
    5 to 9 days post-therapy
    Title
    The Number of Patients Who Experience Any Drug-related Adverse Experiences Leading to Discontinuation of Parenteral Study Drug and the Number of Patients With Any Drug-related Serious Adverse Experiences (AEs) During Parenteral Treatment
    Description
    Safety was assessed by statistical and/or clinical review of all safety parameters, including adverse experiences, physical examination, vital signs, and laboratory results during parenteral therapy. As per the primary safety hypothesis, it was expected that, at the end of the parenteral therapy only, MK0826 would be similar to ceftriaxone with respect to the proportion of patients with any drug-related clinical or laboratory adverse experiences leading to discontinuation of study drug and also with respect to the proportion of patients with any serious drug-related adverse experiences.
    Time Frame
    Adverse experiences that occurred during the study parenteral therapy period were analyzed. The period of parenteral therapy is from 3 days up to 14 days
    Secondary Outcome Measure Information:
    Title
    Clinical Response Assessment Profile
    Description
    The difference in favorable clinical response rates between the 2 treatment groups (MK0826 response rate minus ceftriaxone response rate) was assessed
    Time Frame
    5 to 9 days post-therapy

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Adult patients with a suspected or documented complicated urinary tract infection Female patients must test negative for pregnancy and agree to use adequate birth control measures Nursing women must agree to defer breastfeeding until 5 days after completion of all study antibiotic therapy Exclusion Criteria: Patients with complete obstruction of any portion of the urinary tract Patients with rapidly progressive or terminal illness Renal transplant patients
    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

    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
    22563210
    Citation
    Park DW, Peck KR, Chung MH, Lee JS, Park YS, Kim HY, Lee MS, Kim JY, Yeom JS, Kim MJ. Comparison of ertapenem and ceftriaxone therapy for acute pyelonephritis and other complicated urinary tract infections in Korean adults: a randomized, double-blind, multicenter trial. J Korean Med Sci. 2012 May;27(5):476-83. doi: 10.3346/jkms.2012.27.5.476. Epub 2012 Apr 25.
    Results Reference
    result

    Learn more about this trial

    Safety and Tolerability of Ertapenem Sodium in the Treatment of Complicated Urinary Tract Infections (0826-055)

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