Phase 2 Trial of TD-6424 (Telavancin) Versus Standard Therapy for Complicated Gram Positive Skin and Skin Structure Infections (Gram Positive cSSSI) (FAST2)
Infections, Gram-positive Bacterial
About this trial
This is an interventional treatment trial for Infections, Gram-positive Bacterial focused on measuring Abscess, Burns, Cellulitis, Ulcer, Wound infections
Eligibility Criteria
Inclusion Criteria: Patients must have a diagnosis of one of the following complicated skin and soft tissue infections and either a suspected or confirmed Gram positive organism 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 infection Patients must be expected to require at least 4 days of intravenous (IV) 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 drug 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
- Paradise Valley Hospital, 2400 E. 4th Street
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Telavancin
Standard of care for cSSSI
cSSSI - comlicated skin and skin structure infections