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

This study has been withdrawn prior to enrollment.
(Terminated)
Sponsor:
Information provided by (Responsible Party):
Paratek Pharmaceuticals Inc
ClinicalTrials.gov Identifier:
NCT00876850
First received: April 6, 2009
Last updated: May 8, 2012
Last verified: May 2012
  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
Skin Structures and Soft Tissue Infections
Drug: PTK 0796
Drug: Linezolid
Phase 3

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:


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 ]

Enrollment: 0
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Sponsors and Collaborators
Paratek Pharmaceuticals Inc
Investigators
Study Director: Robert Arbeit, MD Paratek Pharmaceuticals Inc
  More Information

No publications provided

Responsible Party: Paratek Pharmaceuticals Inc
ClinicalTrials.gov Identifier: NCT00876850     History of Changes
Other Study ID Numbers: PTK 0796-CSSI-0805
Study First Received: April 6, 2009
Last Updated: May 8, 2012
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 Pública 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:
Communicable Diseases
Infection
Soft Tissue Infections
Linezolid
Anti-Infective Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protein Synthesis Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014