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

• Status: Withdrawn
• Trial end date: 2010-08-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Paratek Pharmaceuticals Inc
• Treatments: Linezolid

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