Status:
WITHDRAWN
Phase 3 Study - Safety and Efficacy of PTK 0796 in Patients With Complicated Skin and Skin Structure Infection (CSSSI)
Lead Sponsor:
Paratek Pharmaceuticals Inc
Conditions:
Skin Structures and Soft Tissue Infections
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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).
Detailed Description
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....
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2010
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00876850
Start Date
July 1 2009
End Date
August 1 2010
Last Update
May 9 2012
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