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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| JNJ-32729463 | Experimental | JNJ-32729463 250 mg tablet and matching linezolid placebo twice daily |
|
| linezolid | Active Comparator | linezolid 600 mg tablet and matching JNJ-32729463 placebo twice daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| JNJ-32729463 | Drug | 250 mg tablet twice daily |
| |
| linezolid |
| Measure | Description | Time Frame |
|---|---|---|
| Cessation of spread or reduction in the size of the primary infection site lesion | 48-72 hours | |
| Defervescence | 48 - 72 hours |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
Other protocol-specific eligibility criteria may apply
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Furiex Research Site | Anaheim | California | 92804 | United States | ||
| Furiex Research Site |
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| Drug |
600 mg tablet twice daily |
|
|
| JNJ-32729463 placebo | Drug | 1 placebo tablet twice daily |
|
| linezolid placebo | Drug | 1 placebo tablet, twice daily |
|
| Microbiological response rate - overall and for MRSA | 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 | Day 15-21 (SFU/EOT visit) |
| 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) |
| 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 | Saint 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 |
| ID | Term |
|---|---|
| D000038 | Abscess |
| D002481 | Cellulitis |
| D001424 | Bacterial Infections |
| D012874 | Skin Diseases, Infectious |
| D012871 | Skin Diseases |
| D014946 | Wound Infection |
| ID | Term |
|---|---|
| D013492 | Suppuration |
| D007239 | Infections |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001423 | Bacterial Infections and Mycoses |
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| ID | Term |
|---|---|
| D000069349 | Linezolid |
| ID | Term |
|---|---|
| D000081 | Acetamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000085 | Acetates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D023303 | Oxazolidinones |
| D010080 | Oxazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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