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

Primary Purpose

Complicated Skin and Skin Structure Infections

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
JNJ-32729463
linezolid
JNJ-32729463 placebo
linezolid placebo
Sponsored by
Furiex Pharmaceuticals, Inc
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Complicated Skin and Skin Structure Infections focused on measuring 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

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Furiex Research Site
  • Furiex Research Site
  • Furiex Research Site
  • Furiex Research Site
  • Furiex Research Site
  • Furiex Research Site
  • Furiex Research Site
  • Furiex Research Site
  • Furiex Research Site
  • Furiex Research Site
  • Furiex Research Site
  • Furiex Research Site
  • Furiex Research Site
  • Furiex Research Site
  • Furiex Research Site
  • Furiex Research Site
  • Furiex Research Site
  • Furiex Research Site
  • Furiex Research Site
  • Furiex Research Site
  • Furiex Research Site
  • Furiex Research Site
  • Furiex Research Site
  • Furiex Research Site
  • Furiex Research Site
  • Furiex Research Site
  • Furiex Research Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

JNJ-32729463

linezolid

Arm Description

JNJ-32729463 250 mg tablet and matching linezolid placebo twice daily

linezolid 600 mg tablet and matching JNJ-32729463 placebo twice daily

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
May 20, 2010
Last Updated
December 9, 2011
Sponsor
Furiex Pharmaceuticals, Inc
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1. Study Identification

Unique Protocol Identification Number
NCT01128530
Brief Title
Efficacy and Safety Study of JNJ-32729463 for Treating Complicated Skin and Skin Structure Infections Compared to Linezolid (Zyvox)
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 Type
Interventional

2. Study Status

Record Verification Date
December 2011
Overall Recruitment Status
Completed
Study Start Date
June 2010 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
January 2011 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Furiex Pharmaceuticals, Inc

4. Oversight

Data Monitoring Committee
No

5. 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Complicated Skin and Skin Structure Infections
Keywords
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
161 (Actual)

8. Arms, Groups, and Interventions

Arm Title
JNJ-32729463
Arm Type
Experimental
Arm Description
JNJ-32729463 250 mg tablet and matching linezolid placebo twice daily
Arm Title
linezolid
Arm Type
Active Comparator
Arm Description
linezolid 600 mg tablet and matching JNJ-32729463 placebo twice daily
Intervention Type
Drug
Intervention Name(s)
JNJ-32729463
Intervention Description
250 mg tablet twice daily
Intervention Type
Drug
Intervention Name(s)
linezolid
Other Intervention Name(s)
Zyvox
Intervention Description
600 mg tablet twice daily
Intervention Type
Drug
Intervention Name(s)
JNJ-32729463 placebo
Intervention Description
1 placebo tablet twice daily
Intervention Type
Drug
Intervention Name(s)
linezolid placebo
Intervention Description
1 placebo tablet, twice daily
Primary Outcome Measure Information:
Title
Cessation of spread or reduction in the size of the primary infection site lesion
Time Frame
48-72 hours
Title
Defervescence
Time Frame
48 - 72 hours
Secondary Outcome Measure Information:
Title
Severity of signs and symptoms of the primary infection site lesion
Time Frame
up to day 84-98 (late follow-up visit)
Title
Clinical response rate - overall and for MRSA
Time Frame
Day 10 (TOC visit), Day 15-21 (SFU/EOT visit)
Title
Microbiological response rate - overall and for MRSA
Time Frame
Day 15-21 (SFU/EOT visit)
Title
Change in susceptibility testing of S. aureus
Description
Changes in susceptibility testing of S. aureus isolates from the original infection site to linezolid and JNJ-32729463
Time Frame
Day 15-21 (SFU/EOT visit)
Title
Rate of recurrence and new infection in subjects with MRSA
Time Frame
Day 35-49 and Day 84-98
Title
Defervescence
Time Frame
Day 4 (Visit 3)
Title
Cessation of spread or reduction in the size of the primary infection site lesion
Time Frame
Day 4 (Visit 3)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Furiex Research Site
City
Anaheim
State/Province
California
ZIP/Postal Code
92804
Country
United States
Facility Name
Furiex Research Site
City
Buena Park
State/Province
California
ZIP/Postal Code
90620
Country
United States
Facility Name
Furiex Research Site
City
Chula Vista
State/Province
California
ZIP/Postal Code
91911
Country
United States
Facility Name
Furiex Research Site
City
Fountain Valley
State/Province
California
ZIP/Postal Code
92708
Country
United States
Facility Name
Furiex Research Site
City
La Mesa
State/Province
California
ZIP/Postal Code
91942
Country
United States
Facility Name
Furiex Research Site
City
Long Beach
State/Province
California
ZIP/Postal Code
90813
Country
United States
Facility Name
Furiex Research Site
City
Oceanside
State/Province
California
ZIP/Postal Code
92056
Country
United States
Facility Name
Furiex Research Site
City
Santa Ana
State/Province
California
ZIP/Postal Code
92701
Country
United States
Facility Name
Furiex Research Site
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33912
Country
United States
Facility Name
Furiex Research Site
City
Kissimmee
State/Province
Florida
ZIP/Postal Code
34741
Country
United States
Facility Name
Furiex Research Site
City
St. Cloud
State/Province
Florida
ZIP/Postal Code
34769
Country
United States
Facility Name
Furiex Research Site
City
Columbus
State/Province
Georgia
ZIP/Postal Code
31904
Country
United States
Facility Name
Furiex Research Site
City
Savannah
State/Province
Georgia
ZIP/Postal Code
31406
Country
United States
Facility Name
Furiex Research Site
City
Idaho Falls
State/Province
Idaho
ZIP/Postal Code
83404
Country
United States
Facility Name
Furiex Research Site
City
Libertyville
State/Province
Illinois
ZIP/Postal Code
60048
Country
United States
Facility Name
Furiex Research Site
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70809
Country
United States
Facility Name
Furiex Research Site
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Facility Name
Furiex Research Site
City
Sulphur
State/Province
Louisiana
ZIP/Postal Code
70663
Country
United States
Facility Name
Furiex Research Site
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
Furiex Research Site
City
Keego Harbor
State/Province
Michigan
ZIP/Postal Code
48320
Country
United States
Facility Name
Furiex Research Site
City
Butte
State/Province
Montana
ZIP/Postal Code
59701
Country
United States
Facility Name
Furiex Research Site
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43608
Country
United States
Facility Name
Furiex Research Site
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
Furiex Research Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77002
Country
United States
Facility Name
Furiex Research Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77005
Country
United States
Facility Name
Furiex Research Site
City
Sugar Land
State/Province
Texas
ZIP/Postal Code
77498
Country
United States
Facility Name
Furiex Research Site
City
Webster
State/Province
Texas
ZIP/Postal Code
77598
Country
United States

12. IPD Sharing Statement

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

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