Conditions: Infectious Skin Disease Bacterial Skin Disease
Keywords: CSSSI
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 234
Healthy volunteers: no

Brief summary:
A Phase II trial to demonstrate the safety and efficacy of PTK 0796 in the treatment of complicated skin and skin structure infections (cSSSI).

Detailed description:
The pharmacologic profile of PTK 0796 in humans suggests that it has the potential to be used safely and effectively for this indication. Data from in vitro and animal studies support this hypothesis.

In PTK 0796-CSSI-0702 the safety and efficacy of PTK 0796 in the treatment of cSSSI will be compared to an antibiotic approved for this indication by FDA. Initial treatment will be administered intravenously with the option for subsequent oral treatment.

Arms:
arm 1: None arm 2: None

Interventions: intervention 1: PTK 0796 intervention 2: Linezolid
Intervention descriptions: intervention 1: PTK 0796 100 mg for injection; PTK 0796 capsule 100 mg intervention 2: Pre-mixed 600 mg IV infusion solution; Linezolid 600 mg tablets

Protocol document: