Comparison of Telavancin and Vancomycin for Hospital-acquired Pneumonia Due to Methicillin-resistant Staphylococcus Aureus ATTAIN1
- Conditions
- -J189 Pneumonia, unspecifiedPneumonia, unspecifiedJ189
- Registration Number
- PER-042-06
- Lead Sponsor
- THERAVANCE INC (OMNICARE CLINICAL RESEARCH),
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Not specified
- Target Recruitment
- 0
1. Men and women ≥ 18 years of age.
2. Clinical signs and symptoms compatible with acquired pneumonia after at least 48 hours of continuous stay in an acute or chronic care hospital, or acquired within 7 days after being discharged after hospitalization of ≥ 3 days of duration.
3. Chest x-ray with results compatible with a diagnosis of pneumonia within 48 hours prior to randomization in the study.
4. Availability of respiratory or sputum specimens appropriate for Gram stain and culture, and venous access for IV dosing.
5. Willingness to receive intravenous treatment throughout the treatment.
6. Patients from whom informed consent can be obtained to participate in the study, as defined by the Teaching and Research Committee or the Ethics Committee.
755/5000
1. Patient who received more than 24 hours of systemic antibiotic treatment potentially effective for Gram-positive pneumonia immediately before randomization.
2. Respiratory tract or sputum samples with only Gram negative bacteria in Gram stain or culture.
3. Patient with confirmed MSSA or S. pneumoniae infection and who will require more than 24 hours of concomitant treatment of the study medication with an antibiotic for coverage against Gram-negative that has activity against MSSA or S. pneumoniae.
4. Suspicion or confirmation of pulmonary disease that does not allow to evaluate the therapeutic response, cystic fibrosis or active tuberculosis.
5. Suspicion or confirmation of pneumonia due to Legionella pneumophila.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method