Clinical trial NCT00865280: Study the Safety and Efficacy of PTK 0796 in Patients With Complicated Skin and Skin Structure Infection (CSSSI)
Official title: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Skin Diseases, Infectious
Keywords: CSSI
Abscess
Wound
Cellulitis
Complicated Skin and Skin Structure Infections (cSSSI)
Lead sponsor: Paratek Pharmaceuticals Inc
Sponsor class: INDUSTRY
Collaborators: name: Novartis Pharmaceuticals
First posted: 2009-03-19
Enrollment: 143
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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-0804 the safety and efficacy of PTK 0796 in the treatment of cSSSI will be compared to an antibiotic approved for this indication by FDA. Initial treatment will be administered intravenously with the option for subsequent oral treatment.

Eligibility criteria: 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

Primary outcomes:
measure: 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
measure: 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)
measure: 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
measure: 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
measure: 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)
measure: 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)
Secondary outcomes:
measure: Number of Participants With the Indicated Type of Adverse Event (AE)
timeFrame: from the time of informed consent to Test of Cure (10 to 17 days after end of treatment [total treatment of up to 14 days)
Other outcomes:
Locations:
city: Fountain Valley
country: United States
facility: Paratek Recruiting Site
state: California
city: La Mesa
country: United States
facility: Parateck Recruiting Site
state: California
city: Oceanside
country: United States
facility: Paratek Recruiting Site
state: California
city: San Diego
country: United States
facility: Paratek Recruiting Site
state: California
city: San Jose
country: United States
facility: Paratek Recruiting Site
state: California
city: Columbus
country: United States
facility: Parateck Recruiting Site
state: Georgia
city: Savannah
country: United States
facility: Paratek Recruiting Site
state: Georgia
Study officials:
affiliation: Paratek Pharmaceuticals
name: Mary West
role: STUDY_DIRECTOR
References: