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

This study has been terminated.

(Terminated)

Sponsor:

Collaborator:

Novartis Pharmaceuticals

Information provided by (Responsible Party):

Paratek Pharmaceuticals Inc

ClinicalTrials.gov Identifier:

NCT00865280

First received: March 17, 2009

Last updated: May 20, 2013

Last verified: May 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

March 17, 2009

Last Updated Date

May 20, 2013

Start Date ^ICMJE

March 2009

Primary Completion Date

April 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Clinical success at follow-up [ Time Frame: 4 weeks after enrollment ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00865280 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

To evaluate safety of dosing regimens. [ Time Frame: 4 weeks after enrollment ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

A Phase III 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-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.

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Condition ^ICMJE

Skin Diseases, Infectious

Intervention ^ICMJE

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

Other Name: PTK 0796
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

Other Name: Zyvox™; Avelox™

Study Arm (s)

Experimental: PTK 0796
PTK 0796 100mg for injection; PTK 0796 tablet, 150 mg

Intervention: Drug: PTK 0796
Active Comparator: 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

Intervention: Drug: linezolid

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Terminated

Enrollment ^ICMJE

143

Completion Date

April 2010

Primary Completion Date

April 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00865280

Other Study ID Numbers ^ICMJE

PTK 0796 CSSI-0804

Has Data Monitoring Committee

Responsible Party

Paratek Pharmaceuticals Inc

Study Sponsor ^ICMJE

Paratek Pharmaceuticals Inc

Collaborators ^ICMJE

Novartis Pharmaceuticals

Investigators ^ICMJE

Study Director:

Mary West

Paratek Pharmaceuticals

Information Provided By

Paratek Pharmaceuticals Inc

Verification Date

May 2013

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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