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To Evaluate the Treatment Effect of an Anti-Infective Agent for Different Kinds of Infections (0826-052)

Primary Purpose

Infection, Pneumonia, Urinary Tract Infection

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
MK0826, ertapenem sodium / Duration of Treatment: 14 Days
Sponsored by
Merck Sharp & Dohme LLC
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Infection

Eligibility Criteria

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

Inclusion Criteria:

  • Male or female patients, 20 years of age or older
  • Patients did not receive any systemic antibiotic before enrollment, or patients with failed clinical response (no improvement on symptoms or laboratory data) through previous antibiotic treatment
  • Patients who required therapy prior to identification of cause of infection

Exclusion Criteria:

  • Patient has a concomitant infection that may interfere with the evaluation of the response to ertapenem
  • Patient has an apache ii > 30.
  • Patient has an infection caused by pathogens resistant to ertapenem
  • Patients with known allergy to ertapenem or other drugs in the same carbapenem class, beta - lactams, lidocaine or local anesthetics of the amide type
  • The patient requires antibiotics other than ertapenem (such as: glycopeptides, macrolides or antifungal agents)

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Signs and symptoms of infection on days 3, 4, 7 and 14 during treatment

    Secondary Outcome Measures

    Safety and Tolerability

    Full Information

    First Posted
    November 9, 2006
    Last Updated
    February 16, 2017
    Sponsor
    Merck Sharp & Dohme LLC
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00398099
    Brief Title
    To Evaluate the Treatment Effect of an Anti-Infective Agent for Different Kinds of Infections (0826-052)
    Official Title
    Clinical Evaluation for the Efficacy, Safety, Tolerability & Medical Resource Utilization of Invanz (Ertapenem Sodium) Therapy
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    July 2005 (undefined)
    Primary Completion Date
    January 2006 (Actual)
    Study Completion Date
    January 2006 (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
    To collect clinical response data with the use of ertapenem in approved indications.

    6. Conditions and Keywords

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

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    30 (false)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    MK0826, ertapenem sodium / Duration of Treatment: 14 Days
    Primary Outcome Measure Information:
    Title
    Signs and symptoms of infection on days 3, 4, 7 and 14 during treatment
    Secondary Outcome Measure Information:
    Title
    Safety and Tolerability

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Male or female patients, 20 years of age or older Patients did not receive any systemic antibiotic before enrollment, or patients with failed clinical response (no improvement on symptoms or laboratory data) through previous antibiotic treatment Patients who required therapy prior to identification of cause of infection Exclusion Criteria: Patient has a concomitant infection that may interfere with the evaluation of the response to ertapenem Patient has an apache ii > 30. Patient has an infection caused by pathogens resistant to ertapenem Patients with known allergy to ertapenem or other drugs in the same carbapenem class, beta - lactams, lidocaine or local anesthetics of the amide type The patient requires antibiotics other than ertapenem (such as: glycopeptides, macrolides or antifungal agents)
    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

    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

    To Evaluate the Treatment Effect of an Anti-Infective Agent for Different Kinds of Infections (0826-052)

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