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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 23, 2014