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

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

143 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-04-04

Study Completion Date

2010-04-15

Brief Summary

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

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Detailed Description

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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.

Conditions

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Skin Diseases, Infectious

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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PTK 0796

PTK 0796 100 mg for injection; PTK 0796 tablet, 300 mg (2 x 150 mg tablets)

Group Type EXPERIMENTAL

PTK 0796

Intervention Type DRUG

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

Linezolid

Gram positive treatment: Linezolid 600 mg tablets and pre-mixed 600 mg IV infusion solution; Gram negative treatment: moxifloxacin 400 mg tablet and moxifloxacin 400 mg IV infusion solution

Group Type ACTIVE_COMPARATOR

linezolid

Intervention Type DRUG

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

moxifloxacin

Intervention Type DRUG

moxifloxacin 400 mg tablet; moxifloxacin 400 mg IV infusion solution

Interventions

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PTK 0796

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

Intervention Type DRUG

linezolid

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

Intervention Type DRUG

moxifloxacin

moxifloxacin 400 mg tablet; moxifloxacin 400 mg IV infusion solution

Intervention Type DRUG

Other Intervention Names

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omadacycline Zyvox™; Avelox™

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No