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

Primary Purpose

Skin Structures and Soft Tissue Infections

Status
Withdrawn
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
PTK 0796
Linezolid
Sponsored by
Paratek Pharmaceuticals Inc
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Skin Structures and Soft Tissue Infections focused on measuring cSSI, Abscess, Would, Cellulitis, Complicated Skin and Skin Structure Infections (cSSSI)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    PTK 0796

    Linezolid

    Arm Description

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

    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

    Outcomes

    Primary Outcome Measures

    Clinical success at follow-up

    Secondary Outcome Measures

    To evaluate safety of dosing regimens

    Full Information

    First Posted
    April 6, 2009
    Last Updated
    May 8, 2012
    Sponsor
    Paratek Pharmaceuticals Inc
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00876850
    Brief Title
    Phase 3 Study - Safety and Efficacy of PTK 0796 in Patients With Complicated Skin and Skin Structure Infection (CSSSI)
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2012
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    Terminated
    Study Start Date
    July 2009 (undefined)
    Primary Completion Date
    July 2010 (Anticipated)
    Study Completion Date
    August 2010 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Paratek Pharmaceuticals Inc

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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-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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Skin Structures and Soft Tissue Infections
    Keywords
    cSSI, Abscess, Would, Cellulitis, Complicated Skin and Skin Structure Infections (cSSSI)

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    PTK 0796
    Arm Type
    Experimental
    Arm Description
    PTK 0796 100mg for injection; PTK 0796 tablet 150mg
    Arm Title
    Linezolid
    Arm Type
    Active Comparator
    Arm Description
    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
    Intervention Type
    Drug
    Intervention Name(s)
    PTK 0796
    Intervention Description
    PTK 0796 100mg for injection; PTK 0796 tablet 150mg
    Intervention Type
    Drug
    Intervention Name(s)
    Linezolid
    Other Intervention Name(s)
    Zyvox™; Avelox™
    Intervention Description
    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
    Primary Outcome Measure Information:
    Title
    Clinical success at follow-up
    Time Frame
    4 weeks after enrollment
    Secondary Outcome Measure Information:
    Title
    To evaluate safety of dosing regimens
    Time Frame
    4 weeks after enrollment

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Robert Arbeit, MD
    Organizational Affiliation
    Paratek Pharmaceuticals Inc
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Learn more about this trial

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

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