At a glance
ClinicalIndex Comparison Record- ✓Diagnosis of complicated skin and soft tissue infection (major abscess requiring I&D, infected burn, deep/extensive cellulitis, infected ulcer, or wound infection) with suspected or confirmed gram-positive organism
- ✓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 prior to first dose, unless pathogen was resistant to prior treatment or patient was a treatment failure (no clinical improvement 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. Completed, enrolled 201 participants across 1 site.
Detailed Summary
Serious infections caused by resistant bacteria are becoming more of a medical problem throughout the world. This study will measure how well TD-6424 (Telavancin) can control infections and whether the drug is safe to give to patients.
Study Details
Timeline
Interventions
Telavancin 7.5 mg/kg/day, amended to 10 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.