Phase 2 Trial of TD-6424 (Telavancin) Versus Standard Therapy for Complicated Gram Positive Skin and Skin Structure Infections (Gram Positive cSSSI)

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