Phase 3 Study - Safety and Efficacy of PTK 0796 in Patients With Complicated Skin and Skin Structure Infection (CSSSI)

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Skin Structures and Soft Tissue Infections

Intervention / Treatment
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* Drug: PTK 0796
* Drug: Linezolid


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Has and acute complicated skin and skin structure infection with findings of systemic inflammatory response Patients, ages 18 years or older Is expected to require greater than or equal to 4 days antibiotic therapy Female patients must not be pregnant at the time of enrollment and must agree to a reliable method of birth control during the study and for 30 days following the last dose of study drug Exclusion Criteria: Has received an investigational drug within the past 1 month Has been previously enrolled in this protocol Has received >48hr of potentially effective systemic antibiotic immediately prior to study drug Is nursing

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PTK 0796<br>PTK 0796 100mg for injection; PTK 0796 tablet 150mg | Drug: PTK 0796<br>* PTK 0796 100mg for injection; PTK 0796 tablet 150mg<br>|
| Active Comparator: Linezolid<br>For gram positive treatment: Linezolid 600 mg tablets and pre-mixed 600mg IV infusion solution; For gram negative treatment: Moxifloxacin 400 mg tablets and pre-mixed 400mg IV infusion solution | Drug: Linezolid<br>* For gram positive treatment: Linezolid 600 mg tablets and pre-mixed 600mg IV infusion solution; For gram negative treatment: Moxifloxacin 400mg tablets and pre-mixed 400mg IV infusion solution<br>* Other names: Zyvox™; Avelox™;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical success at follow-up |  | 4 weeks after enrollment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate safety of dosing regimens |  | 4 weeks after enrollment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cSSI, Abscess, Would, Cellulitis, Complicated Skin and Skin Structure Infections (cSSSI)