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

Information source: Furiex Pharmaceuticals, Inc
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Complicated Skin and Skin Structure Infections

Intervention: JNJ-32729463 (Drug); linezolid (Drug); JNJ-32729463 placebo (Drug); linezolid placebo (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Furiex Pharmaceuticals, Inc

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).

Clinical Details

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

Primary outcome:

Cessation of spread or reduction in the size of the primary infection site lesion

Defervescence

Secondary outcome:

Severity of signs and symptoms of the primary infection site lesion

Clinical response rate - overall and for MRSA

Microbiological response rate - overall and for MRSA

Change in susceptibility testing of S. aureus

Rate of recurrence and new infection in subjects with MRSA

Defervescence

Cessation of spread or reduction in the size of the primary infection site lesion

Eligibility

Minimum age: 18 Years. Maximum age: 70 Years. Gender(s): Both.

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

Locations and Contacts

Furiex Research Site, Anaheim, California 92804, United States

Furiex Research Site, Buena Park, California 90620, United States

Furiex Research Site, Chula Vista, California 91911, United States

Furiex Research Site, Fountain Valley, California 92708, United States

Furiex Research Site, La Mesa, California 91942, United States

Furiex Research Site, Long Beach, California 90813, United States

Furiex Research Site, Oceanside, California 92056, United States

Furiex Research Site, Santa Ana, California 92701, United States

Furiex Research Site, Fort Myers, Florida 33912, United States

Furiex Research Site, Kissimmee, Florida 34741, United States

Furiex Research Site, St. Cloud, Florida 34769, United States

Furiex Research Site, Columbus, Georgia 31904, United States

Furiex Research Site, Savannah, Georgia 31406, United States

Furiex Research Site, Idaho Falls, Idaho 83404, United States

Furiex Research Site, Libertyville, Illinois 60048, United States

Furiex Research Site, Baton Rouge, Louisiana 70809, United States

Furiex Research Site, New Orleans, Louisiana 70112, United States

Furiex Research Site, Sulphur, Louisiana 70663, United States

Furiex Research Site, Detroit, Michigan 48202, United States

Furiex Research Site, Keego Harbor, Michigan 48320, United States

Furiex Research Site, Butte, Montana 59701, United States

Furiex Research Site, Toledo, Ohio 43608, United States

Furiex Research Site, Philadelphia, Pennsylvania 19107, United States

Furiex Research Site, Houston, Texas 77002, United States

Furiex Research Site, Houston, Texas 77005, United States

Furiex Research Site, Sugar Land, Texas 77498, United States

Furiex Research Site, Webster, Texas 77598, United States

Additional Information

Journal article reporting results of the Phase 2 study

Starting date: June 2010
Last updated: December 9, 2011

Page last updated: August 23, 2015

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