Phase 2
N=234
Study the Efficacy and Safety of PTK 0796 in Patients With Complicated Skin and Skin Structure Infection (CSSSI)
Infectious Skin Disease · Bacterial Skin Disease
Bottom Line
View on ClinicalTrials.gov: NCT03716024 ↗Enrolled (actual)
234
Serious AEs
1.4%
Results posted
Oct 2020
Primary outcome: Primary: Number of Participants With Clinical Response in the Modified Intent-to-Treat (mITT) Population — 75; 59; 9; 19 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- PTK 0796 (Drug); Linezolid (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Paratek Pharmaceuticals Inc
- Primary completion
- Jan 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Clinical Response in the Modified Intent-to-Treat (mITT) Population |
75; 59; 9; 19; 2; 4 | — |
| PRIMARY Number of Participants With Clinical Response in the Clinically Evaluable (CE) Population |
98; 82; 2; 6 | — |
| SECONDARY Number of Participants With Microbiologic Response in the mITT Population |
73; 57; 11; 21 | — |
| SECONDARY Number of Participants With Microbiologic Response in the Microbiologically Evaluable (ME) Population |
73; 57; 4; 6 | — |
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).
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT03716024). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.