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

This study has been completed.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp. Identifier:
First received: March 6, 2007
Last updated: February 15, 2017
Last verified: February 2017
The primary objective of this study is a comparison between MK0787B and standard therapy.

Condition Intervention Phase
Drug: MK0787B, imipenem/cilastatin sodium / Duration of Treatment: 7 Days
Drug: Comparator: amikacin / Duration of Treatment: 3 Days
Drug: Comparator: tazocin / Duration of Treatment: 3 Days
Drug: Comparator: vancomycin / Duration of Treatment: 3 Days
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: No masking
Primary Purpose: Treatment
Official Title: A De-Escalating Strategy for Antibiotic Treatment of Pneumonia in The Medical Intensive Care Unit

Resource links provided by NLM:

Further study details as provided by Merck Sharp & Dohme Corp.:

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

Enrollment: 120
Study Start Date: November 2006
Study Completion Date: January 2007
Primary Completion Date: January 2007 (Final data collection date for primary outcome measure)

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00445094

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
  More Information

Additional Information:
Study Data/Documents: CSR Synopsis  This link exits the site

Responsible Party: Merck Sharp & Dohme Corp. Identifier: NCT00445094     History of Changes
Other Study ID Numbers: 0787B-092
Study First Received: March 6, 2007
Last Updated: February 15, 2017

Additional relevant MeSH terms:
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Anti-Bacterial Agents
Anti-Infective Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action processed this record on May 24, 2017