Phase 3 Study to Compare the Safety and Efficacy of PTK 0796 in Patients With Complicated Skin and Skin Structure Infection (CSSSI) - Full Text View

Sponsor:	Paratek Pharmaceuticals Inc
Information provided by:	Paratek Pharmaceuticals Inc
ClinicalTrials.gov Identifier:	NCT00876850

Purpose

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

Condition	Intervention	Phase
Complicated Skin and Skin Structure Infections cSSSI	Drug: PTK 0796 Drug: Linezolid	Phase III

Paratek Pharmaceuticals Inc has indicated that access to an investigational treatment associated with this study is available outside the clinical trial.

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	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

Resource links provided by NLM:

Drug Information available for: Moxifloxacin Linezolid Moxifloxacin hydrochloride

U.S. FDA Resources

Further study details as provided by Paratek Pharmaceuticals Inc:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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

Estimated Enrollment:	789
Study Start Date:	July 2009
Estimated Study Completion Date:	August 2010
Estimated Primary Completion Date:	July 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: PTK 0796 PTK 0796 100mg for injection; PTK 0796 tablet 150mg	Drug: PTK 0796 PTK 0796 100mg for injection; PTK 0796 tablet 150mg Other Name: PTK 0796
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 Name: Zyvox™; Avelox™

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00876850

Contacts

Contact: Study Director

cssi@paratekpharm.com

Sponsors and Collaborators

Paratek Pharmaceuticals Inc

Investigators

Study Director:

Robert Arbeit, MD

Paratek Pharmaceuticals Inc

More Information

No publications provided

Responsible Party:	Robert Arbeit, MD, Paratek Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00876850 History of Changes
Other Study ID Numbers:	PTK 0796-CSSI-0805
Study First Received:	April 6, 2009
Last Updated:	April 6, 2009
Health Authority:	Argentina: Ministry of Health; Belgium: Federal Agency for Medicinal Products and Health Products; Brazil: Ministry of Health; Germany: Federal Institute for Drugs and Medical Devices; Chile: Instituto de Salud Publica de Chile; Israel: Ministry of Health; Peru: Ministry of Health; Poland: Ministry of Health; Russia: FSI Scientific Center of Expertise of Medical Application; South Africa: Medicines Control Council; Ukraine: Ministry of Health; United Kingdom: Medicines and Healthcare Products Regulatory Agency; United States: Food and Drug Administration

Keywords provided by Paratek Pharmaceuticals Inc:

cSSI
Abscess
Would
Cellulitis
Complicated Skin and Skin Structure Infections (cSSSI)

Additional relevant MeSH terms:

Linezolid
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on February 09, 2012