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

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

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).

Study Overview

• Status: Completed
• Conditions: Complicated Skin and Skin Structure Infections
• Intervention / Treatment: Drug: JNJ-32729463; Drug: linezolid placebo; Drug: linezolid; Drug: JNJ-32729463 placebo

• Study Type: Interventional
• Enrollment (Actual): 161
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • California
    • Anaheim, California, United States, 92804
      • Furiex research site
    • Buena Park, California, United States, 90620
      • Furiex research site
    • Chula Vista, California, United States, 91911
      • Furiex research site
    • Fountain Valley, California, United States, 92708
      • Furiex research site
    • La Mesa, California, United States, 91942
      • Furiex research site
    • Long Beach, California, United States, 90813
      • Furiex research site
    • Oceanside, California, United States, 92056
      • Furiex research site
    • Santa Ana, California, United States, 92701
      • Furiex research site
  • Florida
    • Fort Myers, Florida, United States, 33912
      • Furiex research site
    • Kissimmee, Florida, United States, 34741
      • Furiex research site
    • St. Cloud, Florida, United States, 34769
      • Furiex research site
  • Georgia
    • Columbus, Georgia, United States, 31904
      • Furiex research site
    • Savannah, Georgia, United States, 31406
      • Furiex research site
  • Idaho
    • Idaho Falls, Idaho, United States, 83404
      • Furiex research site
  • Illinois
    • Libertyville, Illinois, United States, 60048
      • Furiex research site
  • Louisiana
    • Baton Rouge, Louisiana, United States, 70809
      • Furiex research site
    • New Orleans, Louisiana, United States, 70112
      • Furiex research site
    • Sulphur, Louisiana, United States, 70663
      • Furiex research site
  • Michigan
    • Detroit, Michigan, United States, 48202
      • Furiex research site
    • Keego Harbor, Michigan, United States, 48320
      • Furiex research site
  • Montana
    • Butte, Montana, United States, 59701
      • Furiex research site
  • Ohio
    • Toledo, Ohio, United States, 43608
      • Furiex research site
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19107
      • Furiex research site
  • Texas
    • Houston, Texas, United States, 77005
      • Furiex research site
    • Houston, Texas, United States, 77002
      • Furiex research site
    • Sugar Land, Texas, United States, 77498
      • Furiex research site
    • Webster, Texas, United States, 77598
      • Furiex research site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: JNJ-32729463; JNJ-32729463 250 mg tablet and matching linezolid placebo twice daily	Drug: JNJ-32729463; 250 mg tablet twice daily; Drug: linezolid placebo; 1 placebo tablet, twice daily
Active Comparator: linezolid; linezolid 600 mg tablet and matching JNJ-32729463 placebo twice daily	Drug: linezolid; 600 mg tablet twice daily; Other Names: Zyvox; Drug: JNJ-32729463 placebo; 1 placebo tablet twice daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Cessation of spread or reduction in the size of the primary infection site lesion	48-72 hours
Defervescence	48 - 72 hours

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Furiex Pharmaceuticals, Inc

Publications and helpful links

Helpful Links

• Journal article reporting results of the Phase 2 study

Study record dates

Study Major Dates

• Study Start: June 1, 2010
• Primary Completion (Actual): December 1, 2010
• Study Completion (Actual): January 1, 2011

Study Registration Dates

• First Submitted: May 20, 2010
• First Submitted That Met QC Criteria: May 20, 2010
• First Posted (Estimate): May 24, 2010

Study Record Updates

• Last Update Posted (Estimate): December 16, 2011
• Last Update Submitted That Met QC Criteria: December 9, 2011
• Last Verified: December 1, 2011

More Information

Terms related to this study

• Keywords: wound infection; cSSSI; skin diseases; bacterial infections; abscess; anti-bacterial agents; anti-infective agents; cellulitis; complicated skin and skin structure infections; acute bacterial skin and skin structure infections; skin diseases, infectious
• Additional Relevant MeSH Terms: Pathologic Processes; Skin Diseases; Disease Attributes; Bacterial Infections; Bacterial Infections and Mycoses; Skin Diseases, Infectious; Infections; Communicable Diseases; Skin Diseases, Bacterial; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Anti-Bacterial Agents; Protein Synthesis Inhibitors; Linezolid
• Other Study ID Numbers: 32729463CSI2001