search
Back to results

A De-Escalating Strategy for Antibiotic Treatment of Pneumonia in The Medical Intensive Care Unit (0787B-092)

Primary Purpose

Infection, Pneumonia

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
MK0787B, imipenem/cilastatin sodium / Duration of Treatment: 7 Days
Comparator: amikacin / Duration of Treatment: 3 Days
Comparator: tazocin / Duration of Treatment: 3 Days
Comparator: vancomycin / Duration of Treatment: 3 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

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

Inclusion Criteria:

  • Greater than 18 years of age
  • Patient is diagnosed with nosocomial pneumonia

Exclusion Criteria:

  • Immunological deficient patients
  • Pregnant women and nursing mothers
  • A fungus is identified before the study enrollment
  • Received vancomycin or imipenem for more than 5 days before icu admission

Sites / Locations

    Outcomes

    Primary Outcome Measures

    A 30-day-survival rate in the intensive care unit evaluated by Acute Physiology and Chronic Health (APACH II) Disease Classification System II score

    Secondary Outcome Measures

    Full Information

    First Posted
    March 6, 2007
    Last Updated
    February 15, 2017
    Sponsor
    Merck Sharp & Dohme LLC
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT00445094
    Brief Title
    A De-Escalating Strategy for Antibiotic Treatment of Pneumonia in The Medical Intensive Care Unit (0787B-092)
    Official Title
    A De-Escalating Strategy for Antibiotic Treatment of Pneumonia in The Medical Intensive Care Unit
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    November 2006 (undefined)
    Primary Completion Date
    January 2007 (Actual)
    Study Completion Date
    January 2007 (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
    The primary objective of this study is a comparison between MK0787B and standard therapy.

    6. Conditions and Keywords

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

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    120 (Actual)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    MK0787B, imipenem/cilastatin sodium / Duration of Treatment: 7 Days
    Intervention Type
    Drug
    Intervention Name(s)
    Comparator: amikacin / Duration of Treatment: 3 Days
    Intervention Type
    Drug
    Intervention Name(s)
    Comparator: tazocin / Duration of Treatment: 3 Days
    Intervention Type
    Drug
    Intervention Name(s)
    Comparator: vancomycin / Duration of Treatment: 3 Days
    Primary Outcome Measure Information:
    Title
    A 30-day-survival rate in the intensive care unit evaluated by Acute Physiology and Chronic Health (APACH II) Disease Classification System II score

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Greater than 18 years of age Patient is diagnosed with nosocomial pneumonia Exclusion Criteria: Immunological deficient patients Pregnant women and nursing mothers A fungus is identified before the study enrollment Received vancomycin or imipenem for more than 5 days before icu admission
    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

    Links:
    URL
    http://www.merck.com/clinical-trials/policies-perspectives.html
    Description
    Click here to access a synopsis of the study results.
    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

    A De-Escalating Strategy for Antibiotic Treatment of Pneumonia in The Medical Intensive Care Unit (0787B-092)

    We'll reach out to this number within 24 hrs