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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.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00445094
First Posted: March 8, 2007
Last Update Posted: February 17, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
  Purpose
The primary objective of this study is a comparison between MK0787B and standard therapy.

Condition Intervention Phase
Infection Pneumonia 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: None (Open Label)
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)
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00445094


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

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

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00445094     History of Changes
Other Study ID Numbers: 0787B-092
2007_004
First Submitted: March 6, 2007
First Posted: March 8, 2007
Last Update Posted: February 17, 2017
Last Verified: February 2017

Additional relevant MeSH terms:
Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Anti-Bacterial Agents
Vancomycin
Imipenem
Amikacin
Cilastatin
Anti-Infective Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action