Study the Efficacy and Safety of PTK 0796 in Patients With Complicated Skin and Skin Structure Infection (CSSSI)
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|ClinicalTrials.gov Identifier: NCT03716024|
Recruitment Status : Completed
First Posted : October 23, 2018
Last Update Posted : October 23, 2018
|Condition or disease||Intervention/treatment||Phase|
|Infectious Skin Disease Bacterial Skin Disease||Drug: PTK0796 Drug: Linezolid||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||234 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||A Randomized, Active Comparator-controlled,Evaluator-blinded, Multicenter Phase 2 Study Comparing PTK 0796 and Linezolid for the Treatment of Adults With Complicated Skin and Skin Structure Infections (cSSSI)|
|Actual Study Start Date :||July 18, 2007|
|Actual Primary Completion Date :||January 7, 2008|
|Actual Study Completion Date :||January 7, 2008|
PTK 0796 100mg for injection; PTK 0796 tablet 100mg
|Active Comparator: Linezolid||
Pre-mixed 600 mg IV infusion solution; Linezolid 600 mg tablets
- Clinical Success at Test of Cure Visit [ Time Frame: 10-17 days after last dose ]Clinical success is categorized as survival with the infection responding adequately such that antibiotics were no longer required (based on the investigator's assessment) without receiving rescue antibacterial therapy. Signs and symptoms of infection include the size, presence of drainage, tenderness, edema, erythema, and induration and were assessed by the investigator to make assessments of response.