TR-701 FA vs. Linezolid for the Treatment of Acute Bacterial Skin and Skin Structure Infections. (ABSSSI)
This study has been completed.
Sponsor:
Trius Therapeutics, Inc.
Information provided by (Responsible Party):
Trius Therapeutics, Inc.
ClinicalTrials.gov Identifier:
NCT01170221
First received: July 23, 2010
Last updated: June 11, 2013
Last verified: November 2011
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Purpose
This is a randomized, double-blind, double dummy, multicenter Phase 3 study of oral TR-701 FA 200 mg once daily for 6 days versus oral Zyvox® (linezolid) 600 mg every 12 hours for 10 days for the treatment of ABSSSI in adults.
Approximately 75 to 100 sites globally will participate in this study. Patients with an ABSSSI caused by suspected or documented gram positive pathogen(s) at baseline will be randomized 1:1 to study treatment
| Condition | Intervention | Phase |
|---|---|---|
|
Skin and Subcutaneous Tissue Bacterial Infections |
Drug: TR-701 FA Drug: Linezolid |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | A Phase 3 Randomized, Double-Blind, Multicenter Study Comparing the Efficacy and Safety of 6-Day Oral TR-701 Free Acid and 10-Day Oral Linezolid for the Treatment of Acute Bacterial Skin and Skin Structure Infections |
Resource links provided by NLM:
MedlinePlus related topics:
Bacterial Infections
Drug Information available for:
Linezolid
U.S. FDA Resources
Further study details as provided by Trius Therapeutics, Inc.:
Primary Outcome Measures:
- To determine noninferiority (NI) in the early clinical response rate [ Time Frame: 48-72 hours ] [ Designated as safety issue: No ]To determine the noninferiority (NI) in the early clinical response rate of 6-day oral TR-701 free acid (FA) compared with that of 10-day oral linezolid treatment at 48-72 hours in the Intent-to-Treat (ITT) analysis set in patients with acute bacterial skin and skin structure infections (ABSSSI)
Secondary Outcome Measures:
- To compare the clinical response of 6-day TR-701 FA and 10-day linezolid treatment at 48-72 hours that is sustained at the End of Therapy (EOT) Visit (Day 11) in the ITT and Clinically Evaluable at EOT (CE-EOT) analysis sets [ Time Frame: Day 11 ] [ Designated as safety issue: No ]
- To compare the Investigator's assessment of clinical success at the Post-Therapy Evaluation (PTE) Visit (7-14 days after the EOT Visit) in the ITT and Clinically Evaluable at PTE (CE-PTE) analysis sets [ Time Frame: 7-14 days after the EOT Visit ] [ Designated as safety issue: No ]
- To compare the Investigator's assessment of clinical response at the 48-72 Hour and Day 7 Visits in the ITT analysis set [ Time Frame: 48-72 Hour and Day 7 Visits ] [ Designated as safety issue: No ]
- To compare patient-reported pain, by study visit [ Time Frame: Multiple Visits ] [ Designated as safety issue: No ]
- To evaluate the safety profile of TR-701 FA in comparison with that of linezolid [ Time Frame: Multiple Visits ] [ Designated as safety issue: Yes ]
- To assess the population pharmacokinetic (PK) profile of TR-700 [ Time Frame: Multiple Visits ] [ Designated as safety issue: No ]
| Enrollment: | 668 |
| Study Start Date: | August 2010 |
| Study Completion Date: | September 2011 |
| Primary Completion Date: | September 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: TR-701 FA
TR0-701 FA 200 mg tablets once a day for six days followed by 4 days of placebo
|
Drug: TR-701 FA
Oral TR-701 FA 200 mg once daily for six days followed by four days of placebo.
Other Names:
|
|
Active Comparator: Linezolid
Linezolid 600 mg tablets oral twice a day for 10 days
|
Drug: Linezolid
Oral Linezolid 600 mg twice daily for 10 days
Other Names:
|
Detailed Description:
The primary objective is to determine the noninferiority in the early clinical response rate of 6 day oral TR-701 FA compared with that of 10-day oral linezolid treatment at the 48-72 Hour Visit in the ITT analysis set in patients with ABSSSI.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Patients with systemic signs of infection diagnosed with acute bacterial skin and skin structure infection (ABSSSI)
- Diagnosed with Cellulitis/ erysipelas, major cutaneous abscess, or wound infections
Exclusion Criteria:
- Uncomplicated skin infections
- Severe sepsis or septic shock
- ABSSSI solely due to gram-negative pathogens
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01170221
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Hide Study LocationsLocations
| United States, Alabama | |
| Trius investigator site 109 | |
| Dothan, Alabama, United States, 36301 | |
| United States, California | |
| Trius investigator site 118 | |
| Anaheim, California, United States, 92804 | |
| Trius Investigator site 130 | |
| Anaheim, California, United States, 92801 | |
| Trius investigator site 129 | |
| Buena Park, California, United States, 90620 | |
| Trius Investigator Site 103 | |
| Chula Vista, California, United States, 91911 | |
| Trius Investigator Site 105 | |
| La Mesa, California, United States, 91942 | |
| Trius investigator site 126 | |
| Laguna Beach, California, United States, 92651 | |
| Trius investigator site 125 | |
| Norwalk, California, United States, 90650 | |
| Trius Investigator Site 104 | |
| Oceanside, California, United States, 92056 | |
| Trius investigator site 113 | |
| Oxnard, California, United States, 93030 | |
| Trius investigator site 123 | |
| Pasadena, California, United States, 91105 | |
| Trius Investigator Site 106 | |
| Rolling Hills Estates, California, United States, 90274 | |
| Trius investigator site 132 | |
| Torrance, California, United States, 90502 | |
| Trius investigator site 111 | |
| Torrance, California, United States, 90501 | |
| United States, Florida | |
| Trius investigator site 127 | |
| Ft. Lauderdale, Florida, United States, 33308 | |
| Trius investigator site 135 | |
| Hialeah, Florida, United States, 33012 | |
| United States, Georgia | |
| Trius investigator site 101 | |
| Columbus, Georgia, United States, 31904 | |
| Trius Investigator Site 102 | |
| Savannah, Georgia, United States, 31406 | |
| United States, Illinois | |
| Trius Investigator site 116 | |
| Chicago, Illinois, United States, 60637 | |
| Trius Investigator Site 108 | |
| Springfield, Illinois, United States, 62701 | |
| United States, Indiana | |
| Trius investigator site 112 | |
| Evansville, Indiana, United States, 47714 | |
| United States, Michigan | |
| Trius Investigator Site 107 | |
| Detroit, Michigan, United States, 48202 | |
| United States, Montana | |
| Trius investigator site 133 | |
| Butte, Montana, United States, 59701 | |
| United States, Nevada | |
| Trius investigator site 128 | |
| Las Vegas, Nevada, United States, 89109 | |
| United States, New Jersey | |
| Trius investigator site 115 | |
| Somers Point, New Jersey, United States, 08244 | |
| United States, Ohio | |
| Trius investigator site 114 | |
| Toledo, Ohio, United States, 43608 | |
| United States, Texas | |
| Trius investigator site 120 | |
| Houston, Texas, United States, 77005 | |
| Trius Investigator site 121 | |
| Houston, Texas, United States, 77093 | |
| Trius investigator site 122 | |
| Houston, Texas, United States, 77002 | |
| Trius investigator site 131 | |
| Houston, Texas, United States, 77081 | |
| Argentina | |
| Trius investigator site 307 | |
| Avellaneda, Pcia Buenos Aires, Argentina, B1870CID | |
| Trius investigator site 304 | |
| Loma Hermosa, Pcia Buenos Aires, Argentina, 1657 | |
| Trius investigator site 310 | |
| Buenos Aires, Argentina, C1405CNF | |
| Trius investigator site 309 | |
| Buenos Aires, Argentina, C1181ACH | |
| Trius Investigator site 301 | |
| Cordoba, Argentina, cp5000 | |
| Trius investigator site 300 | |
| Cordoba, Argentina, X5000FAL | |
| Trius investigator site 305 | |
| Córdoba, Argentina, X5000AAI | |
| Trius investigator site 308 | |
| Parana, Argentina, E3100BBJ | |
| Trius investigator site 303 | |
| Rosario, Argentina, S2002QEA | |
| Trius investigator site 306 | |
| Santa Fe, Argentina, S3000EOY | |
| Brazil | |
| Trius investigator site 322 | |
| Barro Preto, Belo Horizonte, Brazil, 30140062 | |
| Trius investigator site 323 | |
| Sao Paulo, SP, Brazil, 04038-705 | |
| Trius investigator site 321 | |
| São José do Rio Preto, SP, Brazil, CEP 15090 000 | |
| Trius investigator site 320 | |
| Belo Horizonte, Brazil, MG - 30150221 | |
| Canada, Manitoba | |
| Trius investigator site 170 | |
| Winnipeg, Manitoba, Canada, R3A 1R9 | |
| Canada, Ontario | |
| Trius investigator site 171 | |
| Hamilton, Ontario, Canada, L8N3Z5 | |
| Trius investigator site 172 | |
| Hamilton, Ontario, Canada, L8N 4A6 | |
| Canada, Quebec | |
| Trius investigator site 175 | |
| Brownsburg, Quebec, Canada, 46112 | |
| Trius investigator site 173 | |
| Chicoutimi, Quebec, Canada, G7H 5H6 | |
| Trius investigator site 174 | |
| Sherbrooke, Quebec, Canada, J1H 5N4 | |
| Czech Republic | |
| Trius investigator site 234 | |
| Hradec Kralove, Czech Republic, 500 05 | |
| Trius investigator site 235 | |
| Melnik, Czech Republic, 276 01 | |
| Trius investigator site 233 | |
| Ostrava, Czech Republic, 708 52 | |
| Trius investigator site 236 | |
| Pardubice, Czech Republic, 532 03 | |
| Trius investigator site 231 | |
| Prague, Czech Republic, 180 81 | |
| Germany | |
| Trius investigator site 201 | |
| Berlin, Germany, 10117 | |
| Trius investigator site 202 | |
| Hanau, Germany, 63450 | |
| Trius investigator site 200 | |
| Mannheim, Germany, 68135 | |
| Trius investigator site 203 | |
| Plauen, Germany, 08529 | |
| Hungary | |
| Trius investigator site 241 | |
| Debrecen, Hungary, H-4032 | |
| Trius investigator site 242 | |
| Komló, Hungary, H-7300 | |
| Trius investigator site 240 | |
| Szeged, Hungary, H-6721 | |
| Latvia | |
| Trius investigator site 258 | |
| Daugavpils, Latvia, LV- 5417 | |
| Trius investigator site 256 | |
| Liepaja, Latvia, LV -3414 | |
| Trius investigator site 257 | |
| Rezekne, Latvia, LV-4600 | |
| Trius investigator site 255 | |
| Riga, Latvia, LV-1002 | |
| Peru | |
| Trius investigator site 343 | |
| Cercado de Lima, Lima, Peru, 01 | |
| Trius investigator site 342 | |
| Miraflores, Lima, Peru, 18 | |
| Trius investigator site 341 | |
| San Juan de Miraflores, Lima, Peru, 29 | |
| Trius investigator site 340 | |
| Arequipa, Peru, 054 | |
| Slovakia | |
| Trius investigator site 251 | |
| Banská Bystrica, Slovakia, 97517 | |
| Trius investigator site 250 | |
| Martin, Slovakia, 036 59 | |
| Ukraine | |
| Trius investigator site 271 | |
| Cherkassy, Ukraine, 18009 | |
| Trius investigator site 263 | |
| Dnepropetrovsk, Ukraine, 49600 | |
| Trius investigator site 264 | |
| Dnepropetrovsk, Ukraine, 49000 | |
| Trius investigator site 269 | |
| Ivano-Frankivsk, Ukraine, 07618 | |
| Trius investigator site 260 | |
| Kharkiv, Ukraine, 61037 | |
| Trius investigator site 261 | |
| Kyiv, Ukraine, 03110 | |
| Trius investigator site 268 | |
| Lviv, Ukraine, 79000 | |
| Trius investigator site 265 | |
| Lviv, Ukraine, 79044 | |
| Trius Investigator site 270 | |
| Ternopil, Ukraine, 46000 | |
| Trius investigator site 266 | |
| Uzhgorod, Ukraine, 88018 | |
| Trius investigator site 262 | |
| Zaporizhzhya, Ukraine, 69032 | |
| Trius investigator site 267 | |
| Zhytomyr, Ukraine, 10002 | |
Sponsors and Collaborators
Trius Therapeutics, Inc.
Investigators
| Study Director: | Philippe G Prokocimer, MD | Trius Therapeutics |
More Information
No publications provided by Trius Therapeutics, Inc.
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Trius Therapeutics, Inc. |
| ClinicalTrials.gov Identifier: | NCT01170221 History of Changes |
| Other Study ID Numbers: | TR701-112 |
| Study First Received: | July 23, 2010 |
| Last Updated: | June 11, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Trius Therapeutics, Inc.:
|
ABSSSI Tedizolid Phosphate TR-701 Acute Bacterial Skin and Skin Structure Infections |
Additional relevant MeSH terms:
|
Bacterial Infections Linezolid Anti-Infective Agents Therapeutic Uses |
Pharmacologic Actions Protein Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on June 17, 2013