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

Paratek Pharmaceuticals Inc

Overview

A Phase III trial to demonstrate the safety and efficacy of PTK 0796 in the treatment of complicated skin and skin structure infections (cSSSI).

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Conditions

Skin Structures and Soft Tissue Infections

Interventions

PTK 0796DRUG

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

LinezolidDRUG

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Clinical success at follow-up

Time frame: 4 weeks after enrollment

Secondary Outcomes

To evaluate safety of dosing regimens

Time frame: 4 weeks after enrollment

Data from ClinicalTrials.gov

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