Comparison of Telavancin and Vancomycin for Hospital-acquired Pneumonia Due to Methicillin-resistant Staphylococcus Aureus (ATTAIN1)
Study 0015 (NCT00107952) compares the safety and effectiveness of an investigational drug, telavancin, with vancomycin for the treatment of hospital-acquired pneumonia.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|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|
- Clinical Response [ Time Frame: 7 - 14 days following end of antibiotic treatment ] [ Designated as safety issue: No ]
Clinical Response: Categorical (Cured, Failed or Indeterminate)
- Failure is at least one of the following: Persistence or progression of signs and symptoms of pneumonia that still require antibiotic therapy; Termination of study med due to "lack of efficacy"; Death on or after Day 3 attributable to primary infection
- Cure: Signs and symptoms of pneumonia improved to the point that no further antibiotics for pneumonia were required, and baseline radiographic findings improved or did not progress.
- Indeterminate: Inability to determine outcome
|Study Start Date:||February 2005|
|Study Completion Date:||July 2007|
|Primary Completion Date:||July 2007 (Final data collection date for primary outcome measure)|
Telavancin 10 mg/kg/day IV for up to 21 days.
|Active Comparator: Vancomycin||
Vancomycin 1 Gm IV q 12 hrs for up to 21 days
|United States, Massachusetts|
|Baystate Medical Center|
|Springfield, Massachusetts, United States, 01199|
|Principal Investigator:||G. Ralph Corey, MD||Duke University|