Phase 3 Study - Safety and Efficacy of PTK 0796 in Patients With Complicated Skin and Skin Structure Infection (CSSSI)

A Randomized, Evaluator-Blinded, Phase 3 Study to Compare the Safety and Efficacy of PTK 0796 With Linezolid in the Treatment of Adults With Complicated Skin and Skin Structure Infection

Status

Withdrawn

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00876850

Enrollment

Registered

2009-04-07

Start date

2009-07-31

Completion date

2010-08-31

Last updated

2012-05-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Skin Structures and Soft Tissue Infections

Keywords

cSSI, Abscess, Would, Cellulitis, Complicated Skin and Skin Structure Infections (cSSSI)

Brief 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).

Detailed description

The pharmacologic profile of PTK 0796 in humans suggests that it has the potential to be used safely and effectively for this indication. Data from in vitro and animal studies support this hypothesis. In PTK 0796-CSSI-0805 the safety and efficacy of PTK 0796 in the treatment of cSSSI will be compared to an antibiotic approved for this indication by the FDA. Initial treatment will be administered intravenously with the option for subsequent oral treatment.

Interventions

DRUGPTK 0796

PTK 0796 100mg for injection; PTK 0796 tablet 150mg

DRUGLinezolid

For gram positive treatment: Linezolid 600 mg tablets and pre-mixed 600mg IV infusion solution; For gram negative treatment: Moxifloxacin 400mg tablets and pre-mixed 400mg IV infusion solution

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Has and acute complicated skin and skin structure infection with findings of systemic inflammatory response * Patients, ages 18 years or older * Is expected to require greater than or equal to 4 days antibiotic therapy * 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 the past 1 month * Has been previously enrolled in this protocol * Has received \>48hr of potentially effective systemic antibiotic immediately prior to study drug * Is nursing

Design outcomes

Primary

Measure	Time frame
Clinical success at follow-up	4 weeks after enrollment

Secondary

Measure	Time frame
To evaluate safety of dosing regimens	4 weeks after enrollment

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026