At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 761 enrolled
Drug / intervention
Telavancin +1 moredrug
Likely dose
Telavancin 10 mg/kg/day IV for up to 21 days; Vancomycin 1 g IV q12h for up to 21 daysAI-extracted
Key inclusion· 1
- ✓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 discharge from hospitalization of ≥3 days duration.
Key exclusion· 1
- ✕Received more than 24 hours of potentially effective systemic (IV, IM, or PO) antibiotic therapy for Gram-positive pneumonia immediately prior to randomization.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 3 clinical trial evaluating Telavancin and Vancomycin for Bacterial Pneumonia. Completed, enrolled 761 participants across 1 site.
Detailed Summary
Study 0015 (NCT00107952) compares the safety and effectiveness of an investigational drug, telavancin, with vancomycin for the treatment of hospital-acquired pneumonia.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBacterial Pneumonia
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartFeb 2005
First PostedApr 2005
Primary CompletionJul 2007
TodayJul 2026
First PostedApr 12, 2005
Enrollment StartFeb 1, 2005
Primary CompletionJul 1, 2007
TodayJul 2, 2026
Enrollment to primary: 2.4 yearsPosted 21.2 years ago
Interventions
Telavancindrug
Telavancin 10 mg/kg/day IV for up to 21 days.
Vancomycindrug
Vancomycin 1 Gm IV q 12 hrs for up to 21 days