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

Paratek Pharmaceuticals Inc234 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

234

Conditions

Infectious Skin Disease Bacterial Skin Disease

Interventions

PTK 0796DRUG

PTK 0796 100 mg for injection; PTK 0796 capsule 100 mg

LinezolidDRUG

Pre-mixed 600 mg IV infusion solution; Linezolid 600 mg tablets

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (11)

Paratek Recruiting Site

Anaheim, California, United States

Paratek Recruiting Site

Buena Park, California, United States

Paratek Recruiting Site

Chula Vista, California, United States

Outcomes

Primary Outcomes

Number of Participants With Clinical Response in the Modified Intent-to-Treat (mITT) Population

Clinical response is defined as clinical success (CS), which is categorized as a determination by a blinded evaluator (BE) that the infection had sufficiently resolved such that antibiotics were no longer needed, the participant (par.) received ≥1 dose of test article, the par. did not receive non-study antibiotics on \>2 calendar days from Day 1 to the Test of Cure assessment, and the par. did not meet any of the criteria for clinical failure. Clinical failure (CF) is categorized as a determination by a BE that the infection had responded inadequately such that alternative antibiotics were needed, the BE discontinued test article due to an adverse event that was possibly/probably related to test article, the primary site of infection was surgically removed, or the par. received potentially effective antibiotics for treatment of the primary infection site on \>2 days after study enrollment. A classification of indeterminate is used for any outcome that was not classified as CS or CF.

Time frame: 10 to 17 days after the last dose of test article (intravenous or oral) (total treatment of up to 14 days)

Number of Participants With Clinical Response in the Clinically Evaluable (CE) Population

Clinical response is defined as CS, which was categorized as a determination by a BE that the infection had sufficiently resolved such that antibiotics were no longer needed, the participant received ≥1 dose of test article, the participant did not receive non-study antibiotics on \>2 calendar days from Day 1 to the Test of Cure assessment, and the participant did not meet any of the criteria for clinical failure. CF was categorized as a determination by a BE that the infection had responded inadequately such that alternative antibiotics were needed, the BE discontinued test article due to an adverse event that was possibly/probably related to test article, the primary site of infection was surgically removed, or the participant received potentially effective antibiotics for treatment of the primary infection site on \>2 days after study enrollment. A classification of indeterminate is used for any outcome that was not classified as CS or CF.

Time frame: 10 to 17 days after the last dose of test article (intravenous or oral) (total treatment of up to 14 days)

Secondary Outcomes

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

Number of Participants With Microbiologic Response in the mITT Population

Microbiological response to treatment was determined using the following classification: (a) microbiologic success: all infecting pathogens isolated at Baseline were eradicated or presumed eradicated at the Test of Cure evaluation and no superinfecting pathogen was isolated from the site of infection under study; (b) microbiological failure: persistence or presumed persistence of one or more infecting pathogens or isolation of a superinfecting pathogen from the site of infection under study.

Time frame: 10 to 17 days after the last dose of test article (intravenous or oral) (total treatment of up to 14 days)

Number of Participants With Microbiologic Response in the Microbiologically Evaluable (ME) Population

Time frame: 10 to 17 days after the last dose of test article (intravenous or oral) (total treatment of up to 14 days)