A De-Escalating Strategy for Antibiotic Treatment of Pneumonia in The Medical Intensive Care Unit (0787B-092)
February 15, 2017 updated by: Merck Sharp & Dohme LLC
A De-Escalating Strategy for Antibiotic Treatment of Pneumonia in The Medical Intensive Care Unit
The primary objective of this study is a comparison between MK0787B and standard therapy.
Study Overview
Status
Completed
Study Type
Interventional
Enrollment (Actual)
120
Phase
- Phase 4
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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A 30-day-survival rate in the intensive care unit evaluated by Acute Physiology and Chronic Health (APACH II) Disease Classification System II score
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2006
Primary Completion (Actual)
January 1, 2007
Study Completion (Actual)
January 1, 2007
Study Registration Dates
First Submitted
March 6, 2007
First Submitted That Met QC Criteria
March 6, 2007
First Posted (Estimate)
March 8, 2007
Study Record Updates
Last Update Posted (Actual)
February 17, 2017
Last Update Submitted That Met QC Criteria
February 15, 2017
Last Verified
February 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Infections
- Respiratory Tract Infections
- Respiratory Tract Diseases
- Lung Diseases
- Pneumonia
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Enzyme Inhibitors
- Protease Inhibitors
- Anti-Bacterial Agents
- beta-Lactamase Inhibitors
- Vancomycin
- Imipenem
- Cilastatin
- Amikacin
- Piperacillin, Tazobactam Drug Combination
- Cilastatin, Imipenem Drug Combination
Other Study ID Numbers
- 0787B-092
- 2007_004
Plan for Individual participant data (IPD)
Study Data/Documents
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.