At a glance
ClinicalIndex Comparison Record- ✓Diagnosis of complicated skin/skin structure infection (abscess, infected burn, deep cellulitis, infected ulcer, or wound infection) with suspected or confirmed Gram-positive organism as major cause
- ✓Expected to require at least 4 days of intravenous antibiotic treatment
- ✕Previous systemic antibacterial therapy (except aztreonam and metronidazole) for >24 hours within 7 days before study drug, unless pathogen was resistant or patient was treatment failure after 3 days
- ✕Burns involving >20% body surface area or third degree/full thickness burns
- ✕Diabetic foot ulcers or ischemic ulcers/wounds
- ✕Necrotizing fasciitis, gas gangrene, or mediastinitis
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 2, Randomized, Double-Blind, Multinational Trial of Intravenous Telavancin Versus Standard Therapy for Treatment of Complicated Gram Positive Skin and Skin Structure Infections (Gram Positive cSSSI)
In Brief
A Phase 2 clinical trial evaluating Telavancin and Vancomycin or antistaphylococcal penicillin for Infections, Gram-Positive Bacterial and 5 related conditions. Completed, enrolled 169 participants across 1 site.
Detailed Summary
Serious infections caused by resistant bacteria are becoming more of a medical problem throughout the world. One of the ways to deal with this problem is to develop new drugs that can control these bacteria. This study will measure how well TD-6424 (Telavancin) can control infections and whether this drug can be safely given to patients.
Study Details
Timeline
Interventions
Telavancin 7.5 mg/kg/day IV (intravenously) for up to 14 days
Vancomycin 1 Gram IV (intravenously) every 12 hrs or nafcillin 2 Grams, oxacillin 2 Grams, or (in South Africa) cloxacillin 0.5 - 1 Gram, IV (intravenously) every 6 hrs for up to 14 days.