Comparison of Telavancin and Vancomycin for Hospital-acquired Pneumonia Due to Methicillin-resistant Staphylococcus Aureus
- Registration Number
- NCT00124020
- Lead Sponsor
- Cumberland Pharmaceuticals
- Brief Summary
Study 0019 (NCT00124020) compares the safety and effectiveness of an investigational drug, telavancin, with vancomycin for the treatment of hospital-acquired pneumonia.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 771
- 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.
- Received more than 24 hours of potentially effective systemic (IV, IM or PO) antibiotic therapy for Gram-positive pneumonia immediately prior to randomization.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Vancomycin Vancomycin - Telavancin Telavancin -
- Primary Outcome Measures
Name Time Method Clinical Response 7-14 days following end of antibiotic treatment Clinical Response: Categorical (Cured, Failed or Indeterminate)
* Failure - 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Sheba Medical Center, Infectious Disease Unit
🇮🇱Tel Hashomer, Israel