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 range

18 Years

Sex

ALL

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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 range

18 Years

Sex

ALL

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)