Clinical trial NCT03716024: Study the Efficacy and Safety of PTK 0796 in Patients With Complicated Skin and Skin Structure Infection (CSSSI)
Official title: A Randomized, Evaluator-Blinded, Phase 2 Study to Compare the Safety and Efficacy of PTK 0796 With Linezolid (Zyvox®) in the Treatment of Adults With Complicated Skin and Skin Structure Infection (cSSSI)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Infectious Skin Disease
Bacterial Skin Disease
Keywords: CSSSI
Lead sponsor: Paratek Pharmaceuticals Inc
Sponsor class: INDUSTRY
First posted: 2018-10-23
Enrollment: 234
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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).

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-0702 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:

1. Patients, ages 18 years to 80 years
2. Has an acute complicated skin and skin structure infection
3. 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:

1. Has received an investigational drug within past 1 month
2. Has been previously enrolled in this protocol
3. Has received \>48 hr of a potentially effective systemic antibiotic immediately prior to study drug
4. Is nursing

Primary outcomes:
measure: Number of Participants With Clinical Response in the Modified Intent-to-Treat (mITT) Population
timeFrame: 10 to 17 days after the last dose of test article (intravenous or oral) (total treatment of up to 14 days)
measure: Number of Participants With Clinical Response in the Clinically Evaluable (CE) Population
timeFrame: 10 to 17 days after the last dose of test article (intravenous or oral) (total treatment of up to 14 days)
Secondary outcomes:
measure: Number of Participants With Microbiologic Response in the mITT Population
timeFrame: 10 to 17 days after the last dose of test article (intravenous or oral) (total treatment of up to 14 days)
measure: Number of Participants With Microbiologic Response in the Microbiologically Evaluable (ME) Population
timeFrame: 10 to 17 days after the last dose of test article (intravenous or oral) (total treatment of up to 14 days)
Other outcomes:
Locations:
city: Anaheim
country: United States
facility: Paratek Recruiting Site
state: California
city: Buena Park
country: United States
facility: Paratek Recruiting Site
state: California
city: Chula Vista
country: United States
facility: Paratek Recruiting Site
state: California
city: Hawaiian Gardens
country: United States
facility: Paratek Recruiting Site
state: California
city: Oceanside
country: United States
facility: Paratek Recruiting Site
state: California
city: San Jose
country: United States
facility: Paratek Recruiting Site
state: California
city: Indianapolis
country: United States
facility: Paratek Recruiting Site
state: Indiana
city: Butte
country: United States
facility: Paratek Recruiting Site
state: Montana
city: Electra
country: United States
facility: Paratek Recruiting Site
state: Texas
city: Houston
country: United States
facility: Paratek Recruiting Site
state: Texas
city: Wichita Falls
country: United States
facility: Paratek Recruiting Site
state: Texas
Study officials:
References: