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

March 17, 2009
May 20, 2013
March 2009
April 2010   (final data collection date for primary outcome measure)
Clinical success at follow-up [ Time Frame: 4 weeks after enrollment ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00865280 on ClinicalTrials.gov Archive Site
To evaluate safety of dosing regimens. [ Time Frame: 4 weeks after enrollment ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Study the Safety and Efficacy of PTK 0796 in Patients With Complicated Skin and Skin Structure Infection (CSSSI)
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).

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Skin Diseases, Infectious
  • 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™
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
143
April 2010
April 2010   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00865280
PTK 0796 CSSI-0804
No
Paratek Pharmaceuticals Inc
Paratek Pharmaceuticals Inc
Novartis Pharmaceuticals
Study Director: Mary West Paratek Pharmaceuticals
Paratek Pharmaceuticals Inc
May 2013

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