Phase 3 Study - Safety and Efficacy of PTK 0796 in Patients With Complicated Skin and Skin Struct… (NCT00876850) | Clinical Trial Compass
WithdrawnPhase 3
Phase 3 Study - Safety and Efficacy of PTK 0796 in Patients With Complicated Skin and Skin Structure Infection (CSSSI)
Stopped: Terminated
0Started 2009-07
Plain-language 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).
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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