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
About this trial
This is an interventional treatment trial for Infection
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
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
NCT ID
NCT00445094
First Posted
March 6, 2007
Last Updated
February 15, 2017
Sponsor
Merck Sharp & Dohme LLC
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)
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