Efficacy and Safety Study of JNJ-32729463 for Treating Complicated Skin and Skin Structure Infections Compared to Linezolid (Zyvox)

Overview

The purpose of this study is to determine the clinical efficacy, safety, and tolerability of a 250 mg BID oral dose of JNJ-32729463 compared with linezolid in subjects with complicated skin and skin structure infections (cSSSIs).

Full Title of Study: “A Randomized, Controlled, Double-Blind, Double Dummy, Multicenter Phase 2 Study of the Safety/Tolerability and Efficacy of JNJ-32729463 Compared With Linezolid (Zyvox) for the Treatment of Complicated Skin and Skin Structure Infection”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: December 2010

Interventions

  • Drug: JNJ-32729463
    • 250 mg tablet twice daily
  • Drug: linezolid
    • 600 mg tablet twice daily
  • Drug: JNJ-32729463 placebo
    • 1 placebo tablet twice daily
  • Drug: linezolid placebo
    • 1 placebo tablet, twice daily

Arms, Groups and Cohorts

  • Experimental: JNJ-32729463
    • JNJ-32729463 250 mg tablet and matching linezolid placebo twice daily
  • Active Comparator: linezolid
    • linezolid 600 mg tablet and matching JNJ-32729463 placebo twice daily

Clinical Trial Outcome Measures

Primary Measures

  • Cessation of spread or reduction in the size of the primary infection site lesion
    • Time Frame: 48-72 hours
  • Defervescence
    • Time Frame: 48 – 72 hours

Secondary Measures

  • Severity of signs and symptoms of the primary infection site lesion
    • Time Frame: up to day 84-98 (late follow-up visit)
  • Clinical response rate – overall and for MRSA
    • Time Frame: Day 10 (TOC visit), Day 15-21 (SFU/EOT visit)
  • Microbiological response rate – overall and for MRSA
    • Time Frame: Day 15-21 (SFU/EOT visit)
  • Change in susceptibility testing of S. aureus
    • Time Frame: Day 15-21 (SFU/EOT visit)
    • Changes in susceptibility testing of S. aureus isolates from the original infection site to linezolid and JNJ-32729463
  • Rate of recurrence and new infection in subjects with MRSA
    • Time Frame: Day 35-49 and Day 84-98
  • Defervescence
    • Time Frame: Day 4 (Visit 3)
  • Cessation of spread or reduction in the size of the primary infection site lesion
    • Time Frame: Day 4 (Visit 3)

Participating in This Clinical Trial

Inclusion Criteria

  • Clinical diagnosis of a complicated skin and skin structure infection (cSSSI) including wound infection, deep cellulitis or severe abscess
  • Women of childbearing potential must agree to use an acceptable form of contraception
  • Infection site offers ability to obtain a microbiological specimen
  • Received only 1 dose of any potentially effective systemic antibiotic within 24 hours of beginning study treatment

Exclusion Criteria

  • History of hypersensitivity or allergic reaction to quinolones or to linezolid
  • Female and pregnant or breastfeeding or may be pregnant
  • Chronic or underlying skin condition surrounding the area of infection that may complicate the assessment of response (e.g. atopic dermatitis, eczema, or psoriasis)
  • Subject has infections with a high cure rate after surgical incision alone after aggressive local skin care
  • Subject has infection(s) suspected to be caused by Gram-negative rods, anaerobic bacteria or unusual pathogens
  • Subject has an infection that is expected to require other antifungal, antimycobacterial, or antibacterial agents in addition to study medication

Other protocol-specific eligibility criteria may apply

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 70 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Furiex Pharmaceuticals, Inc
  • Provider of Information About this Clinical Study
    • June Almenoff, MD, President/CMO, Furiex Pharmaceuticals, Inc

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