Phase 2 Trial of TD 6424 (Telavancin) Versus Standard Therapy for Complicated Gram Positive Skin and Skin Structure Infections (Gram Positive cSSSI) (FAST)
Infections, Gram-Positive Bacterial, Abscess, Burns
About this trial
This is an interventional treatment trial for Infections, Gram-Positive Bacterial
Eligibility Criteria
Inclusion Criteria: Patients must have a diagnosis of one of the following complicated skin and skin structure infections with either a suspected or confirmed Gram positive organism as the major cause of the infection: major abscess requiring surgical incision and drainage infected burn (see exclusion criteria for important qualifications) deep/extensive cellulitis infected ulcer (see exclusion criteria for important qualifications) wound infections Patients must be expected to require at least 4 days of intravenous antibiotic treatment Exclusion Criteria: Previous systemic antibacterial therapy (with the exception of aztreonam and metronidazole) for > 24 hours within 7 days prior to the first dose of study medication unless the pathogen was resistant to prior treatment or the patient was a treatment failure (no clinical improvement after 3 days). Burns involving > 20% of body surface area or third degree/full thickness in nature, diabetic foot ulcers, ischemic ulcers/wounds, necrotizing fasciitis, gas gangrene, or mediastinitis.
Sites / Locations
- eStudy Site, 3450 Bonita Road, Ste 201
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Telavancin
Standard of care for cSSSI
cSSSI - complicated skin and skin structure infections