Phase 3 Study - Safety and Efficacy of PTK 0796 in Patients With Complicated Skin and Skin Structure Infection (CSSSI)

May 8, 2012 updated by: Paratek Pharmaceuticals Inc

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

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

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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-0805 the safety and efficacy of PTK 0796 in the treatment of cSSSI will be compared to an antibiotic approved for this indication by the FDA. Initial treatment will be administered intravenously with the option for subsequent oral treatment.

Study Type

Interventional

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Has and acute complicated skin and skin structure infection with findings of systemic inflammatory response
  • Patients, ages 18 years or older
  • Is expected to require greater than or equal to 4 days antibiotic therapy
  • 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 the past 1 month
  • Has been previously enrolled in this protocol
  • Has received >48hr of potentially effective systemic antibiotic immediately prior to study drug
  • Is nursing

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: PTK 0796
PTK 0796 100mg for injection; PTK 0796 tablet 150mg
Drug: PTK 0796
PTK 0796 100mg for injection; PTK 0796 tablet 150mg
Active Comparator: Linezolid
For gram positive treatment: Linezolid 600 mg tablets and pre-mixed 600mg IV infusion solution; For gram negative treatment: Moxifloxacin 400 mg tablets and pre-mixed 400mg IV infusion solution
Drug: Linezolid
For gram positive treatment: Linezolid 600 mg tablets and pre-mixed 600mg IV infusion solution; For gram negative treatment: Moxifloxacin 400mg tablets and pre-mixed 400mg IV infusion solution
Other Names:
  • Zyvox™; Avelox™

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Clinical success at follow-up
Time Frame: 4 weeks after enrollment
4 weeks after enrollment

Secondary Outcome Measures

Outcome Measure
Time Frame
To evaluate safety of dosing regimens
Time Frame: 4 weeks after enrollment
4 weeks after enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Paratek Pharmaceuticals Inc

Investigators

  • Study Director: Robert Arbeit, MD, Paratek Pharmaceuticals Inc

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2009

Primary Completion (Anticipated)

July 1, 2010

Study Completion (Anticipated)

August 1, 2010

Study Registration Dates

First Submitted

April 6, 2009

First Submitted That Met QC Criteria

April 6, 2009

First Posted (Estimate)

April 7, 2009

Study Record Updates

Last Update Posted (Estimate)

May 9, 2012

Last Update Submitted That Met QC Criteria

May 8, 2012

Last Verified

May 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PTK 0796-CSSI-0805

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Skin Structures and Soft Tissue Infections

Clinical Trials on PTK 0796

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Qatar

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe