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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
  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 Diseases, Infectious
 Drug: PTK 0796
Drug: linezolid
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: 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:

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 ]

Enrollment: 143
Study Start Date: March 2009
Study Completion Date: April 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PTK 0796
PTK 0796 100mg for injection; PTK 0796 tablet, 150 mg
 Drug: PTK 0796
PTK 0796 100mg for injection; PTK 0796 tablet 150mg
Other Name: 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
 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™

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.

  Eligibility

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

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00865280

Locations
United States, California
Paratek Recruiting Site
Fountain Valley, California, United States, 92708
Parateck Recruiting Site
La Mesa, California, United States, 91942
Paratek Recruiting Site
Oceanside, California, United States, 92056
Paratek Recruiting Site
San Diego, California, United States, 92114
Paratek Recruiting Site
San Jose, California, United States, 95154
United States, Georgia
Parateck Recruiting Site
Columbus, Georgia, United States, 31904
Paratek Recruiting Site
Savannah, Georgia, United States, 31406
Sponsors and Collaborators
Paratek Pharmaceuticals Inc
Novartis Pharmaceuticals
Investigators
Study Director: Mary West Paratek Pharmaceuticals
  More Information

No publications provided

Responsible Party: Paratek Pharmaceuticals Inc
ClinicalTrials.gov Identifier: NCT00865280     History of Changes
Other Study ID Numbers: PTK 0796 CSSI-0804
Study First Received: March 17, 2009
Last Updated: May 20, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Paratek Pharmaceuticals Inc:
CSSI
Abscess
Wound
Cellulitis
Complicated Skin and Skin Structure Infections (cSSSI)

Additional relevant MeSH terms:
Communicable Diseases
Infection
Skin Diseases
Skin Diseases, Infectious
Linezolid
Anti-Infective Agents
 Therapeutic Uses
Pharmacologic Actions
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on June 17, 2013