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

NCT ID: NCT00876850

Last Updated: 2012-05-09

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE3
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-07-31
• Study Completion Date: 2010-08-31

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.

Conditions

Skin Structures and Soft Tissue Infections

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

PTK 0796

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

Group Type: EXPERIMENTAL

PTK 0796

Intervention Type: DRUG

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

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

Group Type: ACTIVE_COMPARATOR

Linezolid

Intervention Type: DRUG

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

Interventions

PTK 0796

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

Intervention Type: 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

Intervention Type: DRUG

Other Intervention Names

Zyvox™; Avelox™

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Paratek Pharmaceuticals Inc

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Robert Arbeit, MD

Role: STUDY_DIRECTOR

Paratek Pharmaceuticals Inc

Other Identifiers

PTK 0796-CSSI-0805

Identifier Type: -

Identifier Source: org_study_id