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

Paratek

Status and phase: Completed; Phase 2

Conditions: Bacterial Skin Disease; Infectious Skin Disease

Treatments: Drug: PTK 0796; Drug: Linezolid

Study type: Interventional

Funder types: Industry

Identifiers

NCT03716024

PTK0796-CSSI-0702

Details and patient eligibility

About

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

Full 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.

Enrollment: 234 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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234 participants in 2 patient groups

PTK 0796

Experimental group

Treatment:

Drug: PTK 0796

Linezolid

Active Comparator group

Treatment:

Drug: Linezolid