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Completed

NCT Number: NCT01128530

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

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).

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Key information

Conditions

Complicated Skin and Skin Structure Infections Abscess Bacterial Infections Bacterial Infections and Mycoses Cellulitis Connective Tissue Diseases Infections Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Skin Diseases Skin Diseases, Infectious Skin and Connective Tissue Diseases Suppuration Wound Infection

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Furiex Research Site, Anaheim, California, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

JNJ-32729463

Drug

250 mg tablet twice daily

Linezolid

Drug

600 mg tablet twice daily

Other names: Zyvox

JNJ-32729463 placebo

Drug

1 placebo tablet twice daily

Linezolid placebo

Drug

1 placebo tablet, twice daily

Primary outcomes

  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 outcomes

  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)

Sponsors and collaborators

Lead sponsor

Furiex Pharmaceuticals, Inc

Industry

Registry information

Official study 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

Important dates

Study start
2010
Primary completion
2010
Study completion
2011
First posted
May 24, 2010
Registry last updated
Dec 16, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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