Skin Structures and Soft Tissue Infections Clinical Trial
Official title:
A Randomized, Evaluator-Blinded, Phase 3 Study to Compare the Safety and Efficacy of PTK 0796 With Linezolid in the Treatment of Adults With Complicated Skin and Skin Structure Infection
A Phase III trial to demonstrate the safety and efficacy of PTK 0796 in the treatment of complicated skin and skin structure infections (cSSSI).
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-0805 the safety and efficacy of PTK 0796 in the treatment of cSSSI will be
compared to an antibiotic approved for this indication by the FDA. Initial treatment will be
administered intravenously with the option for subsequent oral treatment.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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