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

December 9, 2011 updated by: Furiex Pharmaceuticals, Inc

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

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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
161

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • 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
        • Furiex research site
    • Florida
      • Fort Myers, Florida, United States, 33912
        • Furiex research site
      • Kissimmee, Florida, United States, 34741
        • Furiex research site
      • St. Cloud, Florida, United States, 34769
        • Furiex research site
    • Georgia
      • Columbus, Georgia, United States, 31904
        • Furiex research site
      • Savannah, Georgia, United States, 31406
        • Furiex research site
    • Idaho
      • Idaho Falls, Idaho, United States, 83404
        • Furiex research site
    • Illinois
      • Libertyville, Illinois, United States, 60048
        • Furiex research site
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70809
        • Furiex research site
      • New Orleans, Louisiana, United States, 70112
        • Furiex research site
      • Sulphur, Louisiana, United States, 70663
        • Furiex research site
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Furiex research site
      • Keego Harbor, Michigan, United States, 48320
        • Furiex research site
    • Montana
      • Butte, Montana, United States, 59701
        • Furiex research site
    • Ohio
      • Toledo, Ohio, United States, 43608
        • Furiex research site
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Furiex research site
    • Texas
      • Houston, Texas, United States, 77005
        • Furiex research site
      • Houston, Texas, United States, 77002
        • Furiex research site
      • Sugar Land, Texas, United States, 77498
        • Furiex research site
      • Webster, Texas, United States, 77598
        • Furiex research site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Cessation of spread or reduction in the size of the primary infection site lesion
Time Frame: 48-72 hours
48-72 hours
Defervescence
Time Frame: 48 - 72 hours
48 - 72 hours

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Severity of signs and symptoms of the primary infection site lesion
Time Frame: up to day 84-98 (late follow-up visit)
up to day 84-98 (late follow-up visit)
Clinical response rate - overall and for MRSA
Time Frame: Day 10 (TOC visit), Day 15-21 (SFU/EOT visit)
Day 10 (TOC visit), Day 15-21 (SFU/EOT visit)
Microbiological response rate - overall and for MRSA
Time Frame: Day 15-21 (SFU/EOT visit)
Day 15-21 (SFU/EOT visit)
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
Day 15-21 (SFU/EOT visit)
Rate of recurrence and new infection in subjects with MRSA
Time Frame: Day 35-49 and Day 84-98
Day 35-49 and Day 84-98
Defervescence
Time Frame: Day 4 (Visit 3)
Day 4 (Visit 3)
Cessation of spread or reduction in the size of the primary infection site lesion
Time Frame: Day 4 (Visit 3)
Day 4 (Visit 3)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Furiex Pharmaceuticals, Inc

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2010

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2010

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2011

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 20, 2010

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 20, 2010

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 24, 2010

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 16, 2011

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 9, 2011

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 32729463CSI2001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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