Study the Efficacy and Safety 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 II 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-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.

Official Title
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A Randomized, Evaluator-Blinded, Phase 2 Study to Compare the Safety and Efficacy of PTK 0796 With Linezolid (Zyvox®) in the Treatment of Adults With Complicated Skin and Skin Structure Infection (cSSSI)

Conditions
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Infectious Skin Disease, Bacterial Skin Disease

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: Patients, ages 18 years to 80 years Has an acute complicated skin and skin structure infection 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 past 1 month Has been previously enrolled in this protocol Has received >48 hr of a potentially effective systemic antibiotic immediately prior to study drug Is nursing

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PTK 0796<br> | Drug: PTK 0796<br>* PTK 0796 100 mg for injection; PTK 0796 capsule 100 mg<br>|
| Active Comparator: Linezolid<br> | Drug: Linezolid<br>* Pre-mixed 600 mg IV infusion solution; Linezolid 600 mg tablets<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Clinical Response in the Modified Intent-to-Treat (mITT) Population | Clinical response is defined as clinical success (CS), which is categorized as a determination by a blinded evaluator (BE) that the infection had sufficiently resolved such that antibiotics were no longer needed, the participant (par.) received ≥1 dose of test article, the par. did not receive non-study antibiotics on >2 calendar days from Day 1 to the Test of Cure assessment, and the par. did not meet any of the criteria for clinical failure. Clinical failure (CF) is categorized as a determination by a BE that the infection had responded inadequately such that alternative antibiotics were needed, the BE discontinued test article due to an adverse event that was possibly/probably related to test article, the primary site of infection was surgically removed, or the par. received potentially effective antibiotics for treatment of the primary infection site on >2 days after study enrollment. A classification of indeterminate is used for any outcome that was not classified as CS or CF. | 10 to 17 days after the last dose of test article (intravenous or oral) (total treatment of up to 14 days) | 
| Number of Participants With Clinical Response in the Clinically Evaluable (CE) Population | Clinical response is defined as CS, which was categorized as a determination by a BE that the infection had sufficiently resolved such that antibiotics were no longer needed, the participant received ≥1 dose of test article, the participant did not receive non-study antibiotics on >2 calendar days from Day 1 to the Test of Cure assessment, and the participant did not meet any of the criteria for clinical failure. CF was categorized as a determination by a BE that the infection had responded inadequately such that alternative antibiotics were needed, the BE discontinued test article due to an adverse event that was possibly/probably related to test article, the primary site of infection was surgically removed, or the participant received potentially effective antibiotics for treatment of the primary infection site on >2 days after study enrollment. A classification of indeterminate is used for any outcome that was not classified as CS or CF. | 10 to 17 days after the last dose of test article (intravenous or oral) (total treatment of up to 14 days) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Microbiologic Response in the mITT Population | Microbiological response to treatment was determined using the following classification: (a) microbiologic success: all infecting pathogens isolated at Baseline were eradicated or presumed eradicated at the Test of Cure evaluation and no superinfecting pathogen was isolated from the site of infection under study; (b) microbiological failure: persistence or presumed persistence of one or more infecting pathogens or isolation of a superinfecting pathogen from the site of infection under study. | 10 to 17 days after the last dose of test article (intravenous or oral) (total treatment of up to 14 days) | 
| Number of Participants With Microbiologic Response in the Microbiologically Evaluable (ME) Population | Microbiological response to treatment was determined using the following classification: (a) microbiologic success: all infecting pathogens isolated at Baseline were eradicated or presumed eradicated at the Test of Cure evaluation and no superinfecting pathogen was isolated from the site of infection under study; (b) microbiological failure: persistence or presumed persistence of one or more infecting pathogens or isolation of a superinfecting pathogen from the site of infection under study. | 10 to 17 days after the last dose of test article (intravenous or oral) (total treatment of up to 14 days) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CSSSI