TerminatedPhase 3

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

Stopped: Terminated

United States143 participantsStarted 2009-04-04

Plain-language 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).

Who can participate

Age range18 Years

SexALL

See this in plain English?

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

Inclusion Criteria: * Patients, ages 18 years or older * Is expected to require ≥4 days of IV antibiotic therapy * Has an acute complicated skin and skin structure infection with findings of systemic inflammatory response * 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 past 1 month * Has been previously enrolled in this protocol * Has received \>24 hr of a potentially effective systemic antibiotic immediately prior to study drug * Is nursing

What they're measuring

Number of Participants Classified as a Sponsor-defined Clinical Success in the Intent-to-Treat (ITT) Population at End of Treatment

Timeframe: up to 14 days

Number of Participants Classified as a Sponsor-defined Clinical Success in the ITT Population at Test of Cure

Timeframe: 10 to 17 days after last dose of treatment (total treatment of up to 14 days)

Number of Participants With Wound Infections Classified as a Sponsor-defined Clinical Success in the Clinically Evaluable (CE) Population at End of Treatment

Timeframe: up to 14 days

Number of Participants With Cellulitis Classified as a Sponsor-defined Clinical Success in the CE Population at End of Treatment

Timeframe: up to 14 days

Number of Participants With Wound Infections Classified as a Sponsor-defined Clinical Success in the CE Population at Test of Cure

Timeframe: 10 to 17 days after last dose of treatment (total treatment of up to 14 days)

Number of Participants With Cellulitis Classified as a Sponsor-defined Clinical Success in the CE Population at Test of Cure

Timeframe: 10 to 17 days after last dose of treatment (total treatment of up to 14 days)

Trial details

NCT IDNCT00865280

SponsorParatek Pharmaceuticals Inc

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2010-04-15

Results submitted2020-09-29

View on ClinicalTrials.gov More Skin Diseases, Infectious trials

Who can participate

Age range18 Years

SexALL

See this in plain English?

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

What they're measuring

Number of Participants Classified as a Sponsor-defined Clinical Success in the Intent-to-Treat (ITT) Population at End of Treatment

Timeframe: up to 14 days

Number of Participants Classified as a Sponsor-defined Clinical Success in the ITT Population at Test of Cure

Timeframe: 10 to 17 days after last dose of treatment (total treatment of up to 14 days)

Number of Participants With Wound Infections Classified as a Sponsor-defined Clinical Success in the Clinically Evaluable (CE) Population at End of Treatment

Timeframe: up to 14 days

Number of Participants With Cellulitis Classified as a Sponsor-defined Clinical Success in the CE Population at End of Treatment

Timeframe: up to 14 days

Number of Participants With Wound Infections Classified as a Sponsor-defined Clinical Success in the CE Population at Test of Cure

Timeframe: 10 to 17 days after last dose of treatment (total treatment of up to 14 days)

Number of Participants With Cellulitis Classified as a Sponsor-defined Clinical Success in the CE Population at Test of Cure

Timeframe: 10 to 17 days after last dose of treatment (total treatment of up to 14 days)