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

Sponsor

Furiex Pharmaceuticals, Inc (Industry)

Overall Status

Completed

CT.gov ID

NCT01128530

Collaborator

(none)

161

Enrollment

Locations

Arms

Duration (Months)

Patients Per Site

0.8

Patients Per Site Per Month

Study Details

Study Description

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

Study Type:

Interventional

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 :

Jun 1, 2010

Actual Primary Completion Date :

Dec 1, 2010

Actual Study Completion Date :

Jan 1, 2011

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Cessation of spread or reduction in the size of the primary infection site lesion [48-72 hours]
Defervescence [48 - 72 hours]

Secondary Outcome Measures

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 [Day 15-21 (SFU/EOT visit)]
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 [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)]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	Furiex Research Site	Anaheim	California	United States	92804
2	Furiex Research Site	Buena Park	California	United States	90620
3	Furiex Research Site	Chula Vista	California	United States	91911
4	Furiex Research Site	Fountain Valley	California	United States	92708
5	Furiex Research Site	La Mesa	California	United States	91942
6	Furiex Research Site	Long Beach	California	United States	90813
7	Furiex Research Site	Oceanside	California	United States	92056
8	Furiex Research Site	Santa Ana	California	United States	92701
9	Furiex Research Site	Fort Myers	Florida	United States	33912
10	Furiex Research Site	Kissimmee	Florida	United States	34741
11	Furiex Research Site	St. Cloud	Florida	United States	34769
12	Furiex Research Site	Columbus	Georgia	United States	31904
13	Furiex Research Site	Savannah	Georgia	United States	31406
14	Furiex Research Site	Idaho Falls	Idaho	United States	83404
15	Furiex Research Site	Libertyville	Illinois	United States	60048
16	Furiex Research Site	Baton Rouge	Louisiana	United States	70809
17	Furiex Research Site	New Orleans	Louisiana	United States	70112
18	Furiex Research Site	Sulphur	Louisiana	United States	70663
19	Furiex Research Site	Detroit	Michigan	United States	48202
20	Furiex Research Site	Keego Harbor	Michigan	United States	48320
21	Furiex Research Site	Butte	Montana	United States	59701
22	Furiex Research Site	Toledo	Ohio	United States	43608
23	Furiex Research Site	Philadelphia	Pennsylvania	United States	19107
24	Furiex Research Site	Houston	Texas	United States	77002
25	Furiex Research Site	Houston	Texas	United States	77005
26	Furiex Research Site	Sugar Land	Texas	United States	77498
27	Furiex Research Site	Webster	Texas	United States	77598