Conditions: Skin Diseases, Infectious
Keywords: CSSI Abscess Wound Cellulitis Complicated Skin and Skin Structure Infections (cSSSI)
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 143
Healthy volunteers: no

Brief summary:
A Phase III 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-0804 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: PTK 0796 100 mg for injection; PTK 0796 tablet, 300 mg (2 x 150 mg tablets) arm 2: Gram positive treatment: Linezolid 600 mg tablets and pre-mixed 600 mg IV infusion solution; Gram negative treatment: moxifloxacin 400 mg tablet and moxifloxacin 400 mg IV infusion solution

Interventions: intervention 1: PTK 0796 intervention 2: linezolid intervention 3: moxifloxacin
Intervention descriptions: intervention 1: PTK 0796 100 mg for injection; PTK 0796 tablet 150 mg intervention 2: For gram positive treatment: Linezolid 600 mg tablets and pre-mixed 600 mg IV infusion solution; For gram negative treatment: Moxifloxacin 400 mg tablets and pre-mixed 400mg IV infusion solution intervention 3: moxifloxacin 400 mg tablet; moxifloxacin 400 mg IV infusion solution

Protocol document: