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

Stopped early · Phase 3

Conditions studied: Skin Diseases, Infectious

In brief

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

Key facts

Study ID

NCT00865280

Run by

Paratek Pharmaceuticals Inc

People needed

143

Starts

2009-04-04

Expected to finish

2010-04-15

Last updated by the study team

2021-03-12

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Paratek Recruiting Site — Fountain Valley, California, United States
• Parateck Recruiting Site — La Mesa, California, United States
• Paratek Recruiting Site — Oceanside, California, United States
• Paratek Recruiting Site — San Diego, California, United States
• Paratek Recruiting Site — San Jose, California, United States
• Parateck Recruiting Site — Columbus, Georgia, United States
• Paratek Recruiting Site — Savannah, Georgia, United States

Full record on ClinicalTrials.gov

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