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

Information source: Merck Sharp & Dohme Corp.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Infection; Pneumonia

Intervention: 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 (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Merck Sharp & Dohme Corp.

Official(s) and/or principal investigator(s):
Medical Monitor, Study Director, Affiliation: Merck Sharp & Dohme Corp.

Summary

The primary objective of this study is a comparison between MK0787B and standard therapy.

Clinical Details

Official title: A De-Escalating Strategy for Antibiotic Treatment of Pneumonia in The Medical Intensive Care Unit

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: A 30-day-survival rate in the intensive care unit evaluated by Acute Physiology and Chronic Health (APACH II) Disease Classification System II score

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Locations and Contacts

Additional Information

Starting date: November 2006
Last updated: September 26, 2014

Page last updated: August 23, 2015

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