CompletedPhase 2

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

United States234 participantsStarted 2007-07-18

Plain-language summary

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

Age range18 Years – 80 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Patients, ages 18 years to 80 years
✓. Has an acute complicated skin and skin structure infection
✓. 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

✕. Has received an investigational drug within past 1 month
✕. Has been previously enrolled in this protocol
✕. Has received \>48 hr of a potentially effective systemic antibiotic immediately prior to study drug
✕. Is nursing

Number of Participants With Clinical Response in the Modified Intent-to-Treat (mITT) Population

Timeframe: 10 to 17 days after the last dose of test article (intravenous or oral) (total treatment of up to 14 days)

Number of Participants With Clinical Response in the Clinically Evaluable (CE) Population

Timeframe: 10 to 17 days after the last dose of test article (intravenous or oral) (total treatment of up to 14 days)

NCT IDNCT03716024

SponsorParatek Pharmaceuticals Inc

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2008-01-07

Results submitted2020-09-17