Phase 3 Study - Safety and Efficacy of PTK 0796 in Patients With Complicated Skin and Skin Structure Infection (CSSSI)

Sponsor

Paratek Pharmaceuticals Inc (Industry)

Overall Status

Withdrawn

CT.gov ID

NCT00876850

Collaborator

(none)

Enrollment

Arms

Duration (Months)

Study Details

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).

Condition or Disease	Intervention/Treatment	Phase
Skin Structures and Soft Tissue Infections	Drug: PTK 0796 Drug: Linezolid	Phase 3

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

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 Start Date :

Jul 1, 2009

Anticipated Primary Completion Date :

Jul 1, 2010

Anticipated Study Completion Date :

Aug 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: PTK 0796 PTK 0796 100mg for injection; PTK 0796 tablet 150mg	Drug: PTK 0796 PTK 0796 100mg for injection; PTK 0796 tablet 150mg
Active Comparator: Linezolid 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	Drug: Linezolid 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 Other Names: Zyvox™; Avelox™

Arm

Intervention/Treatment

Experimental: PTK 0796

PTK 0796 100mg for injection; PTK 0796 tablet 150mg

Drug: PTK 0796

PTK 0796 100mg for injection; PTK 0796 tablet 150mg

Active Comparator: Linezolid

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

Drug: Linezolid

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

Other Names:

Zyvox™; Avelox™

Outcome Measures

Primary Outcome Measures

Clinical success at follow-up [4 weeks after enrollment]

Secondary Outcome Measures

To evaluate safety of dosing regimens [4 weeks after enrollment]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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