Back to resultsPhase 3 Study - Safety and Efficacy of PTK 0796 in Patients With Complicated Skin and Skin Structure Infection (CSSSI)
Primary Purpose
Skin Structures and Soft Tissue Infections
Status
Withdrawn
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
PTK 0796
Linezolid
Sponsored by
About this trial
This is an interventional treatment trial for Skin Structures and Soft Tissue Infections focused on measuring cSSI, Abscess, Would, Cellulitis, Complicated Skin and Skin Structure Infections (cSSSI)
Eligibility 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
PTK 0796
Linezolid
Arm Description
PTK 0796 100mg for injection; PTK 0796 tablet 150mg
For gram positive treatment: Linezolid 600 mg tablets and pre-mixed 600mg IV infusion solution; For gram negative treatment: Moxifloxacin 400 mg tablets and pre-mixed 400mg IV infusion solution
Outcomes
Primary Outcome Measures
Clinical success at follow-up
Secondary Outcome Measures
To evaluate safety of dosing regimens
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00876850
Brief Title
Phase 3 Study - Safety and Efficacy of PTK 0796 in Patients With Complicated Skin and Skin Structure Infection (CSSSI)
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 Type
Interventional
2. Study Status
Record Verification Date
May 2012
Overall Recruitment Status
Withdrawn
Why Stopped
Terminated
Study Start Date
July 2009 (undefined)
Primary Completion Date
July 2010 (Anticipated)
Study Completion Date
August 2010 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Paratek Pharmaceuticals Inc
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Skin Structures and Soft Tissue Infections
Keywords
cSSI, Abscess, Would, Cellulitis, Complicated Skin and Skin Structure Infections (cSSSI)
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
PTK 0796
Arm Type
Experimental
Arm Description
PTK 0796 100mg for injection; PTK 0796 tablet 150mg
Arm Title
Linezolid
Arm Type
Active Comparator
Arm Description
For gram positive treatment: Linezolid 600 mg tablets and pre-mixed 600mg IV infusion solution; For gram negative treatment: Moxifloxacin 400 mg tablets and pre-mixed 400mg IV infusion solution
Intervention Type
Drug
Intervention Name(s)
PTK 0796
Intervention Description
PTK 0796 100mg for injection; PTK 0796 tablet 150mg
Intervention Type
Drug
Intervention Name(s)
Linezolid
Other Intervention Name(s)
Zyvox™; Avelox™
Intervention Description
For gram positive treatment: Linezolid 600 mg tablets and pre-mixed 600mg IV infusion solution; For gram negative treatment: Moxifloxacin 400mg tablets and pre-mixed 400mg IV infusion solution
Primary Outcome Measure Information:
Title
Clinical success at follow-up
Time Frame
4 weeks after enrollment
Secondary Outcome Measure Information:
Title
To evaluate safety of dosing regimens
Time Frame
4 weeks after enrollment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert Arbeit, MD
Organizational Affiliation
Paratek Pharmaceuticals Inc
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
Phase 3 Study - Safety and Efficacy of PTK 0796 in Patients With Complicated Skin and Skin Structure Infection (CSSSI)
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