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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00445094
First received: March 6, 2007
Last updated: October 25, 2013
Last verified: October 2013
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00445094

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

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00445094     History of Changes
Other Study ID Numbers: 0787B-092, 2007_004
Study First Received: March 6, 2007
Last Updated: October 25, 2013
Health Authority: Korea: Food and Drug Administration

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

ClinicalTrials.gov processed this record on April 17, 2014