Comparison of Telavancin and Vancomycin for Hospital-acquired Pneumonia Due to Methicillin-resistant Staphylococcus Aureus
Information source: Theravance Biopharma Antibiotics, Inc.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Bacterial Pneumonia
Intervention: Telavancin (Drug); Vancomycin (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Theravance Biopharma Antibiotics, Inc. Official(s) and/or principal investigator(s):
G. Ralph Corey, MD, Principal Investigator, Affiliation: Duke University
Summary
Study 0019 (NCT00124020) compares the safety and effectiveness of an investigational drug,
telavancin, with vancomycin for the treatment of hospital-acquired pneumonia.
Clinical Details
Official title: A Phase 3, Randomized, Double-Blind, Parallel-Group, Multinational Trial of Intravenous Telavancin Versus Vancomycin for Treatment of Hospital-Acquired Pneumonia With a Focus on Patients With Infections Due to Methicillin-Resistant Staphylococcus Aureus
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Clinical Response
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Clinical signs and symptoms consistent with pneumonia acquired after at least 48
hours of continuous stay in an inpatient acute or chronic care facility or acquired
within 7 days after being discharged from a hospitalization of greater than or equal
to 3 days duration.
Exclusion Criteria:
- Received more than 24 hours of potentially effective systemic (IV, IM or PO)
antibiotic therapy for Gram-positive pneumonia immediately prior to randomization.
Locations and Contacts
Sheba Medical Center, Infectious Disease Unit, Tel Hashomer 52621, Israel
Additional Information
Starting date: January 2005
Last updated: May 14, 2010
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