Phase 3 Study to Compare the Safety and Efficacy of PTK 0796 in Patients With Complicated Skin and Skin Structure Infection (CSSSI)
Information source: Paratek Pharmaceuticals Inc
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Complicated Skin and Skin Structure Infections; cSSSI
Intervention: PTK 0796 (Drug); Linezolid (Drug)
Phase: Phase 3
Status: Not yet recruiting
Sponsored by: Paratek Pharmaceuticals Inc Official(s) and/or principal investigator(s):
Robert Arbeit, MD, Study Director, Affiliation: Paratek Pharmaceuticals Inc
Overall contact:
Study Director, Email: cssi@paratekpharm.com
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).
Clinical Details
Official title: A Randomized, Evaluator-Blinded, Phase 3 Study to Compare the Safety and Efficacy of PTK 0796 With Linezolid in the Treatment of Adults With Complicated Skin and Skin Structure Infection
Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Clinical success at follow-up
Secondary outcome: To evaluate safety of dosing regimens
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.
In PTK 0796-CSSI-0805 the safety and efficacy of PTK 0796 in the treatment of cSSSI will be
compared to an antibiotic approved for this indication by the FDA. Initial treatment will
be administered intravenously with the option for subsequent oral treatment.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Study Director, Email: cssi@paratekpharm.com Additional Information
Starting date: July 2009
Ending date: August 2010
Last updated: April 6, 2009
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