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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01128530
Recruitment Status : Completed
First Posted : May 24, 2010
Last Update Posted : December 16, 2011
Sponsor:
Information provided by:
Furiex Pharmaceuticals, Inc

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Complicated Skin and Skin Structure Infections Drug: JNJ-32729463 Drug: linezolid Drug: JNJ-32729463 placebo Drug: linezolid placebo Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 161 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : June 2010
Actual Primary Completion Date : December 2010
Actual Study Completion Date : January 2011

Resource links provided by the National Library of Medicine

Drug Information available for: Linezolid

Arms and Interventions
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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 Name: Zyvox

Drug: JNJ-32729463 placebo
1 placebo tablet twice daily


Outcome Measures
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Primary Outcome Measures :
  1. Cessation of spread or reduction in the size of the primary infection site lesion [ Time Frame: 48-72 hours ]
  2. Defervescence [ Time Frame: 48 - 72 hours ]

Secondary Outcome Measures :
  1. Severity of signs and symptoms of the primary infection site lesion [ Time Frame: up to day 84-98 (late follow-up visit) ]
  2. Clinical response rate - overall and for MRSA [ Time Frame: Day 10 (TOC visit), Day 15-21 (SFU/EOT visit) ]
  3. Microbiological response rate - overall and for MRSA [ Time Frame: Day 15-21 (SFU/EOT visit) ]
  4. 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

  5. Rate of recurrence and new infection in subjects with MRSA [ Time Frame: Day 35-49 and Day 84-98 ]
  6. Defervescence [ Time Frame: Day 4 (Visit 3) ]
  7. Cessation of spread or reduction in the size of the primary infection site lesion [ Time Frame: Day 4 (Visit 3) ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01128530


Locations
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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
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Responsible Party: June Almenoff, MD, President/CMO, Furiex Pharmaceuticals, Inc
ClinicalTrials.gov Identifier: NCT01128530    
Other Study ID Numbers: 32729463CSI2001
First Posted: May 24, 2010    Key Record Dates
Last Update Posted: December 16, 2011
Last Verified: December 2011
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:
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Infections
Communicable Diseases
Skin Diseases, Bacterial
Disease Attributes
Pathologic Processes
Bacterial Infections
Bacterial Infections and Mycoses
Skin Diseases, Infectious
 Skin Diseases
Linezolid
Anti-Bacterial Agents
Anti-Infective Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action