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

This study has been completed.
Sponsor:
Information provided by:
Furiex Pharmaceuticals, Inc
ClinicalTrials.gov Identifier:
NCT01128530
First received: May 20, 2010
Last updated: December 9, 2011
Last verified: December 2011
  Purpose

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).


Condition Intervention Phase
Complicated Skin and Skin Structure Infections
Drug: JNJ-32729463
Drug: linezolid
Drug: JNJ-32729463 placebo
Drug: linezolid placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Furiex Pharmaceuticals, Inc:

Primary Outcome Measures:
  • Cessation of spread or reduction in the size of the primary infection site lesion [ Time Frame: 48-72 hours ] [ Designated as safety issue: No ]
  • Defervescence [ Time Frame: 48 - 72 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Severity of signs and symptoms of the primary infection site lesion [ Time Frame: up to day 84-98 (late follow-up visit) ] [ Designated as safety issue: No ]
  • Clinical response rate - overall and for MRSA [ Time Frame: Day 10 (TOC visit), Day 15-21 (SFU/EOT visit) ] [ Designated as safety issue: No ]
  • Microbiological response rate - overall and for MRSA [ Time Frame: Day 15-21 (SFU/EOT visit) ] [ Designated as safety issue: No ]
  • Change in susceptibility testing of S. aureus [ Time Frame: Day 15-21 (SFU/EOT visit) ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
  • Defervescence [ Time Frame: Day 4 (Visit 3) ] [ Designated as safety issue: No ]
  • Cessation of spread or reduction in the size of the primary infection site lesion [ Time Frame: Day 4 (Visit 3) ] [ Designated as safety issue: No ]

Enrollment: 161
Study Start Date: June 2010
Study Completion Date: January 2011
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Zyvox
Drug: JNJ-32729463 placebo
1 placebo tablet twice daily

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01128530

Locations
United States, California
Furiex Research Site
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
United States, Florida
Furiex Research Site
Fort Myers, Florida, United States, 33912
Furiex Research Site
Kissimmee, Florida, United States, 34741
Furiex Research Site
St. Cloud, Florida, United States, 34769
United States, Georgia
Furiex Research Site
Columbus, Georgia, United States, 31904
Furiex Research Site
Savannah, Georgia, United States, 31406
United States, Idaho
Furiex Research Site
Idaho Falls, Idaho, United States, 83404
United States, Illinois
Furiex Research Site
Libertyville, Illinois, United States, 60048
United States, Louisiana
Furiex Research Site
Baton Rouge, Louisiana, United States, 70809
Furiex Research Site
New Orleans, Louisiana, United States, 70112
Furiex Research Site
Sulphur, Louisiana, United States, 70663
United States, Michigan
Furiex Research Site
Detroit, Michigan, United States, 48202
Furiex Research Site
Keego Harbor, Michigan, United States, 48320
United States, Montana
Furiex Research Site
Butte, Montana, United States, 59701
United States, Ohio
Furiex Research Site
Toledo, Ohio, United States, 43608
United States, Pennsylvania
Furiex Research Site
Philadelphia, Pennsylvania, United States, 19107
United States, Texas
Furiex Research Site
Houston, Texas, United States, 77002
Furiex Research Site
Houston, Texas, United States, 77005
Furiex Research Site
Sugar Land, Texas, United States, 77498
Furiex Research Site
Webster, Texas, United States, 77598
Sponsors and Collaborators
Furiex Pharmaceuticals, Inc
  More Information

Additional Information:
No publications provided

Responsible Party: June Almenoff, MD, President/CMO, Furiex Pharmaceuticals, Inc
ClinicalTrials.gov Identifier: NCT01128530     History of Changes
Other Study ID Numbers: 32729463CSI2001
Study First Received: May 20, 2010
Last Updated: December 9, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Furiex Pharmaceuticals, Inc:
cSSSI
complicated skin and skin structure infections
acute bacterial skin and skin structure infections
abscess
cellulitis
bacterial infections
anti-bacterial agents
anti-infective agents
skin diseases, infectious
skin diseases
wound infection

Additional relevant MeSH terms:
Linezolid
Anti-Infective Agents
Oxazolidinones
Therapeutic Uses
Pharmacologic Actions
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 24, 2014