Complicated Skin and Skin Structure InfectionsPhase 2NCT01128530
Efficacy and Safety Study of JNJ-32729463 for Treating Complicated Skin and Skin Structure Infections Compared to Linezolid (Zyvox)
A Phase 2 study testing JNJ-32729463 and linezolid in people with Complicated Skin and Skin Structure Infections, run by Furiex Pharmaceuticals, Inc at 27 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Complicated Skin and Skin Structure Infections
- What is being tested?
- JNJ-32729463 and linezolid
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 161 participants
- Where
- 27 sitesUnited States
- Study dates
- Jun 2010to Jan 2011
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
27 sites in 1 country.
27 sites in 1 country
United States27 sites
Furiex Research Site
Anaheim, California, 92804
Furiex Research Site
Baton Rouge, Louisiana, 70809
Furiex Research Site
Buena Park, California, 90620
Furiex Research Site
Butte, Montana, 59701
Furiex Research Site
Chula Vista, California, 91911
Furiex Research Site
Columbus, Georgia, 31904
Furiex Research Site
Detroit, Michigan, 48202
Furiex Research Site
Fort Myers, Florida, 33912
Furiex Research Site
Fountain Valley, California, 92708
Furiex Research Site
Houston, Texas, 77002
Furiex Research Site
Houston, Texas, 77005
Furiex Research Site
Idaho Falls, Idaho, 83404
Furiex Research Site
Keego Harbor, Michigan, 48320
Furiex Research Site
Kissimmee, Florida, 34741
Furiex Research Site
La Mesa, California, 91942
Furiex Research Site
Libertyville, Illinois, 60048
Furiex Research Site
Long Beach, California, 90813
Furiex Research Site
New Orleans, Louisiana, 70112
Furiex Research Site
Oceanside, California, 92056
Furiex Research Site
Philadelphia, Pennsylvania, 19107
Furiex Research Site
Saint Cloud, Florida, 34769
Furiex Research Site
Santa Ana, California, 92701
Furiex Research Site
Savannah, Georgia, 31406
Furiex Research Site
Sugar Land, Texas, 77498
Furiex Research Site
Sulphur, Louisiana, 70663
Furiex Research Site
Toledo, Ohio, 43608
Furiex Research Site
Webster, Texas, 77598
About this study
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
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).
- Being tested
- JNJ-32729463, linezolid, JNJ-32729463 placebo, linezolid placebo
- 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
- Medical subject headings
- Abscess, Cellulitis, Bacterial Infections, Skin Diseases, Infectious, Skin Diseases, Wound Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JNJ-32729463Drug
250 mg tablet twice daily
linezolidDrug
Also called Zyvox
600 mg tablet twice daily
JNJ-32729463 placeboDrug
1 placebo tablet twice daily
linezolid placeboDrug
1 placebo tablet, twice daily
| Study group | Role | What they receive |
|---|---|---|
| JNJ-32729463 | Experimental | JNJ-32729463 250 mg tablet and matching linezolid placebo twice daily Receives: Drug: JNJ-32729463; Drug: linezolid placebo |
| linezolid | Active comparator | linezolid 600 mg tablet and matching JNJ-32729463 placebo twice daily Receives: Drug: linezolid; Drug: JNJ-32729463 placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cessation of spread or reduction in the size of the primary infection site lesion
Measured: 48-72 hours
Defervescence
Measured: 48 - 72 hours
Secondary outcomes (7)
Severity of signs and symptoms of the primary infection site lesion
Measured: up to day 84-98 (late follow-up visit)
Clinical response rate - overall and for MRSA
Measured: Day 10 (TOC visit), Day 15-21 (SFU/EOT visit)
Microbiological response rate - overall and for MRSA
Measured: Day 15-21 (SFU/EOT visit)
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
Measured: Day 15-21 (SFU/EOT visit)
Rate of recurrence and new infection in subjects with MRSA
Measured: Day 35-49 and Day 84-98
Defervescence
Measured: Day 4 (Visit 3)
Cessation of spread or reduction in the size of the primary infection site lesion
Measured: Day 4 (Visit 3)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2010 (estimated)
- Study startJun 2010
- Primary completionDec 2010
- Study completionJan 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Complicated Skin and Skin Structure InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 161 participants (actual)
Sponsor and investigators
- Lead sponsor
- Furiex Pharmaceuticals, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01128530
- Sponsor's protocol ID
- 32729463CSI2001
- Status last verified
- Dec 2011
- First submitted
- 20 May 2010
- Last updated
- 16 Dec 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01128530
- Acronym / sponsor ID
- 32729463CSI2001
- 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
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 161 participants (actual)
- Lead sponsor
- Furiex Pharmaceuticals, IncIndustry (pharma, biotech, devices)
- Study start
- Jun 2010
- Primary completion
- Dec 2010 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 24 May 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| JNJ-32729463 | Experimental | Drug: JNJ-32729463, Drug: linezolid placeboJNJ-32729463 250 mg tablet and matching linezolid placebo twice daily |
| linezolid | Active comparator | Drug: linezolid, Drug: JNJ-32729463 placebolinezolid 600 mg tablet and matching JNJ-32729463 placebo twice daily |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| JNJ-32729463250 mg tablet twice daily | Drug | JNJ-32729463 |
| linezolidAlso: Zyvox600 mg tablet twice daily | Drug | linezolid |
| JNJ-32729463 placebo1 placebo tablet twice daily | Drug | linezolid |
| linezolid placebo1 placebo tablet, twice daily | Drug | JNJ-32729463 |
Primary outcome
Cessation of spread or reduction in the size of the primary infection site lesion
Time frame: 48-72 hours
Defervescence
Time frame: 48 - 72 hours
7 secondary outcomes
Severity of signs and symptoms of the primary infection site lesion
Time frame: 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)
Microbiological response rate - overall and for MRSA
Time frame: Day 15-21 (SFU/EOT visit)
Change in susceptibility testing of S. aureus
Time frame: 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
Defervescence
Time frame: Day 4 (Visit 3)
Cessation of spread or reduction in the size of the primary infection site lesion
Time frame: Day 4 (Visit 3)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
27 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing JNJ-32729463 and linezolid in people with Complicated Skin and Skin Structure Infections, run by Furiex Pharmaceuticals, Inc at 27 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Dec 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 27 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cessation of spread or reduction in the size of the primary infection site lesion (time frame: 48-72 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2011.