Status:
TERMINATED
Study the Safety and Efficacy of PTK 0796 in Patients With Complicated Skin and Skin Structure Infection (CSSSI)
Lead Sponsor:
Paratek Pharmaceuticals Inc
Collaborating Sponsors:
Novartis Pharmaceuticals
Conditions:
Skin Diseases, Infectious
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
- Patients, ages 18 years or older
- Is expected to require ≥4 days of IV antibiotic therapy
- Has an acute complicated skin and skin structure infection with findings of systemic inflammatory response
- 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 past 1 month
- Has been previously enrolled in this protocol
- Has received \>24 hr of a potentially effective systemic antibiotic immediately prior to study drug
- Is nursing
Key Trial Info
Start Date :
April 4 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 15 2010
Estimated Enrollment :
143 Patients enrolled
Trial Details
Trial ID
NCT00865280
Start Date
April 4 2009
End Date
April 15 2010
Last Update
March 12 2021
Active Locations (7)
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1
Paratek Recruiting Site
Fountain Valley, California, United States, 92708
2
Parateck Recruiting Site
La Mesa, California, United States, 91942
3
Paratek Recruiting Site
Oceanside, California, United States, 92056
4
Paratek Recruiting Site
San Diego, California, United States, 92114