TR-701 FA vs Linezolid for the Treatment of Acute Bacterial Skin and Skin Structure Infections
This study has been completed.
Sponsor:
Trius Therapeutics, Inc.
Information provided by (Responsible Party):
Trius Therapeutics, Inc.
ClinicalTrials.gov Identifier:
NCT01421511
First received: August 19, 2011
Last updated: January 30, 2013
Last verified: January 2013
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Purpose
This is a randomized, double-blind, double-dummy, multicenter, global Phase 3 study of IV to oral TR-701 FA 200 mg once daily for 6 days versus IV to oral Zyvox® (linezolid) 600 mg every 12 hours for 10 days for the treatment of ABSSSI in adults. Patients are to start treatment with at least 2 IV doses and may receive IV therapy for the entire treatment duration.
Approximately 100 to 140 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 for 6 days followed by 4 days of placebo Drug: Linezolid for 10 days of treatment |
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 IV to Oral 6-Day TR-701 Free Acid and IV to Oral 10-Day Linezolid for the Treatment of ABSSSI |
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:
- determine the noninferiority (NI) in the early clinical response rate [ Time Frame: 48-72 hours ] [ Designated as safety issue: No ]afebrile with cessation of spread of the erythema, edema, and/or induration or reduction in the size (length, width, and area) of erythema, edema, and/or induration from baseline of the primary ABSSSI lesion and nonresponder
| Enrollment: | 666 |
| Study Start Date: | September 2011 |
| Study Completion Date: | January 2013 |
| Primary Completion Date: | January 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: TR-701 FA
• TR-701 FA IV followed by TR-701 FA tablets
|
Drug: TR-701 FA for 6 days followed by 4 days of placebo
|
|
Active Comparator: Linezolid
• Linezolid IV followed by Linezolid Tablets
|
Drug: Linezolid for 10 days of treatment
|
Detailed Description:
The primary objective is to determine the noninferiority (NI) in the early clinical response rate of intravenous (IV) to oral 6 day TR-701 free acid (FA) compared with that of IV to oral 10-day linezolid treatment at 48-72 hours after the first infusion of study drug in the intent-to-treat (ITT) analysis set in patients with acute bacterial skin and skin structure infections (ABSSSI).
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Patients requiring IV antibiotic therapy and with systemic signs of infection diagnosed with 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: NCT01421511
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| United States, Alabama | |
| Trius investigator site 159 | |
| Dothan, Alabama, United States, 36305 | |
| United States, California | |
| Trius investigator site 103 | |
| Chula Vista, California, United States, 91911 | |
| Trius investigator site 143 | |
| Escondido, California, United States, 92025 | |
| Trius investigator site 105 | |
| La Mesa, California, United States, 91942 | |
| Trius investigator site 106 | |
| Long Beach, California, United States, 90813 | |
| Trius investigator site 157 | |
| Long Beach, California, United States, 90813 | |
| Trius investigator site 142 | |
| National City, California, United States, 91950 | |
| Trius investigator site 170 | |
| San Diego, California, United States, 92123 | |
| Trius investigator site 167 | |
| Santa Ana, California, United States, 92701 | |
| Trius investigator site 168 | |
| Stockton, California, United States, 95204 | |
| Trius investigator site 141 | |
| Sylmar, California, United States, 91342 | |
| United States, Colorado | |
| Trius investigator site 139 | |
| Denver, Colorado, United States, 80218 | |
| United States, Delaware | |
| Trius investigator site 137 | |
| Newark, Delaware, United States, 19718 | |
| United States, Florida | |
| Trius investigator site 166 | |
| Edgewater, Florida, United States, 32132 | |
| United States, Georgia | |
| Trius investigator site 101 | |
| Columbus, Georgia, United States, 31904 | |
| United States, Indiana | |
| Trius investigator site 138 | |
| Carmel, Indiana, United States, 46032 | |
| United States, Kentucky | |
| Trius investigator site 144 | |
| Owensboro, Kentucky, United States, 42303 | |
| United States, Louisiana | |
| Trius investigator site 150 | |
| Baton Rouge, Louisiana, United States, 70809 | |
| Trius investigator site 165 | |
| Eunice, Louisiana, United States, 70535 | |
| United States, Massachusetts | |
| Trius investigator site 154 | |
| Boston, Massachusetts, United States, 02115 | |
| Trius investigator site 146 | |
| Springfield, Massachusetts, United States, 01199 | |
| Trius investigator site 136 | |
| West Roxbury, Massachusetts, United States, 02132 | |
| United States, Michigan | |
| Trius investigator site 163 | |
| Royal Oak, Michigan, United States, 48073 | |
| United States, Minnesota | |
| Trius investigator site 153 | |
| Minneapolis, Minnesota, United States, 55415 | |
| United States, Mississippi | |
| Trius investigator site 149 | |
| Picayune, Mississippi, United States, 39466 | |
| United States, Missouri | |
| Trius investigator site 164 | |
| Creve Coeur, Missouri, United States, 63141 | |
| United States, Nevada | |
| Trius investigator site 160 | |
| Las Vegas, Nevada, United States, 89169 | |
| United States, New Jersey | |
| Trius investigator site 147 | |
| Teaneck, New Jersey, United States, 07666 | |
| United States, Ohio | |
| Trius investigator site 140 | |
| Columbus, Ohio, United States, 43215 | |
| Trius investigator site 162 | |
| Lima, Ohio, United States, 45801 | |
| United States, South Dakota | |
| Trius investigator site 161 | |
| Rapid City, South Dakota, United States, 57702 | |
| United States, Tennessee | |
| Trius investigator site 155 | |
| Franklin, Tennessee, United States, 37064 | |
| Trius investigator site 145 | |
| Memphis, Tennessee, United States, 38104 | |
| Trius investigator site 169 | |
| Smyrna, Tennessee, United States, 37167 | |
| United States, Texas | |
| Trius investigator site 148 | |
| Houston, Texas, United States, 77030 | |
| Argentina | |
| Trius investigator site 352 | |
| Cludadela, Buenos Aires, Argentina, B1702FWM | |
| Trius investigator site 354 | |
| General Roriquez, Buenos Aires, Argentina, B1748 | |
| Trius investigator site 350 | |
| La Plata, Buenos Aires, Argentina, B1900AXI | |
| Trius investigator site 350 | |
| La Plata, Buenos Aires, Argentina | |
| Trius investigator site 353 | |
| Lujan, Buenos Aires, Argentina, B6700AOJ | |
| Trius investigator site 354 | |
| Buenos Aires, Argentina | |
| Trius investigator site 355 | |
| Buenos Aires, Argentina | |
| Trius investigator site 351 | |
| Cludad Autonoma de Buenos Aires, Argentina, C1155AHD | |
| Trius investigator site 358 | |
| La Plata, Argentina | |
| Trius investigator site 357 | |
| Mar del Plata, Argentina | |
| Trius investigator site 359 | |
| Paraná, Entre Rios, Argentina | |
| Trius investigator site 356 | |
| Rosario, Argentina | |
| Australia, Queensland | |
| Trius investigator 500 | |
| Cairns, Queensland, Australia, 4870 | |
| Trius investigator 501 | |
| Herston, Queensland, Australia, 4029 | |
| Trius investigator 503 | |
| Nambour, Queensland, Australia, 4560 | |
| Trius investigator 506 | |
| Southport, Queensland, Australia, 4215 | |
| Trius investigator 502 | |
| Woolloongabba, Queensland, Australia, 4102 | |
| Trius investigator 504 | |
| Woolloongabba, Queensland, Australia, 4102 | |
| Australia, Victoria | |
| Trius investigator 505 | |
| Richmond, Victoria, Australia, 2131 | |
| Brazil | |
| Trius investigator site 362 | |
| Belo Horizonte, MG, Brazil, Brazil, 30110-934 | |
| Trius investigator site 361 | |
| Belo Horizonte, MG, Brazil, Brazil, 30140-062 | |
| Trius investigator site 363 | |
| Porto Alegre, RS, Brazil, Brazil, 90110-270 | |
| Trius investigator site 364 | |
| Campinas, SP, Brazil, Brazil, 13060-904 | |
| Trius investigator site 362 | |
| Belo Horizonte, Brazil | |
| Trius investigator site 361 | |
| Belo Horizonte, Brazil | |
| Trius investigator site 365 | |
| Belo Horizonte, Brazil | |
| Trius investigator site 364 | |
| Campinas, Brazil | |
| Trius investigator site 367 | |
| Curitiba, Brazil | |
| Trius investigator site 366 | |
| Curitiba, Brazil | |
| Trius investigator site 369 | |
| Jaú, Brazil | |
| Trius investigator site 370 | |
| Porto Alegre, Brazil | |
| Trius investigator site 363 | |
| Porto Alegre, Brazil | |
| Trius investigator site 360 | |
| São Paulo, Brazil | |
| Germany | |
| Trius investigator site 206 | |
| Quedlinburg, Sachsen-Anhalt, Germany, 06484 | |
| Trius investigator site 208 | |
| Dresden, Sachsen, Germany, 01307 | |
| Trius investigator site 204 | |
| Luebeck, Schleswig-Holstein, Germany, 23538 | |
| Trius investigator site 207 | |
| Berlin, Germany, 10249 | |
| Trius investigator site 205 | |
| Hamburg, Germany, 20246 | |
| Mexico | |
| Trius investigator site 380 | |
| Guadalajara, Mexico | |
| Trius investigator site 381 | |
| Guadalajara, Mexico | |
| Trius investigator site 382 | |
| Mexico, DF, Mexico | |
| Trius investigator site 383 | |
| Monterrey, Mexico | |
| New Zealand | |
| Trius investigator 521 | |
| Otahuhu, Auckland, New Zealand | |
| Trius investigator 520 | |
| Sydenham, Christchurch, New Zealand, 8024 | |
| Poland | |
| Trius investigator site 216 | |
| Bydgoszcz, Poland, 85-094 | |
| Trius investigator site 211 | |
| Lodz, Poland, 93-513 | |
| Trius investigator site 214 | |
| Lublin, Poland, 20-081 | |
| Trius investigator site 213 | |
| Poznan, Poland, 60-631 | |
| Trius investigator site 215 | |
| Szczecin, Poland, 70-111 | |
| Trius investigator site 212 | |
| Warszawa, Poland, 02-097 | |
| Russian Federation | |
| Trius investigator site 292 | |
| Vsevolozhsk, Leningrad Region, Russian Federation, 188640 | |
| Trius investigator site 287 | |
| Barmaul, Russian Federation, 656024 | |
| Trius investigator site 286 | |
| Irkutsk, Russian Federation, 664079 | |
| Trius investigator site 293 | |
| Lipetsk, Russian Federation, 389035/398005 | |
| Trius investigator site 291 | |
| Moscow, Russian Federation, 115280 | |
| Trius investigator site 295 | |
| Moscow, Russian Federation, 115093 | |
| Trius investigator site 288 | |
| Moscow, Russian Federation, 119435 | |
| Trius investigator site 290 | |
| Moscow, Russian Federation, 115280 | |
| Trius investigator site 285 | |
| Novosibirsk, Russian Federation, 630051 | |
| Trius investigator site 297 | |
| Novosibirsk, Russian Federation, 630008 | |
| Trius investigator site 296 | |
| Saint-Petersburg, Russian Federation | |
| Trius investigator site 289 | |
| Saint-Petersburg, Russian Federation, 198099 | |
| Trius investigator site 294 | |
| saint-Petersburg, Russian Federation, 194291 | |
| Trius investigator site 289 | |
| St-Petersburg, Russian Federation, 198099 | |
| Trius investigator site 298 | |
| Tomsk, Russian Federation, 634063 | |
| South Africa | |
| Trius investigator 444 | |
| Worscester, Cape, South Africa, 6850 | |
| Trius investigator 443 | |
| Port Elizabeth, Eastern Cape, South Africa, 6020 | |
| Trius investigator site 442 | |
| Bloemfontein, Free States, South Africa, 9317 | |
| Trius investigator site 441 | |
| Blowmfontein, Free States, South Africa, 9301 | |
| Trius investigator 451 | |
| Centurion, Gauteng, South Africa, 0157 | |
| Trius investigator site 440 | |
| Gezina Pretoria, Gauteng, South Africa, 0084 | |
| Trius investigator 449 | |
| Pretoria, Gauteng, South Africa, 0084 | |
| Trius investigator 450 | |
| Pretoria, Gauteng, South Africa, 0083 | |
| Trius investigator 448 | |
| Dundee, Kwa Zulu Natal, South Africa, 3000 | |
| Trius investigator 446 | |
| Middelburg, Mpumalanga, South Africa, 1051 | |
| Trius investigator 447 | |
| Breyten, Mpunalanga, South Africa, 2330 | |
| Trius investigator site 445 | |
| Benoni, South Africa, 1501 | |
| Spain | |
| Trius investigator site 273 | |
| Mataro, Barcelona, Spain, 08304 | |
| Trius investigator site 272 | |
| Alcorcon, Madrid, Spain, 28922 | |
| Trius investigator site 275 | |
| Majadahonda, Madrid, Spain, 28222 | |
| Trius investigator site 277 | |
| Baracaldo, Vizcaya, Spain, 48903 | |
| Trius investigator site 276 | |
| Madrid, Spain, 28046 | |
| Trius investigator site 274 | |
| Santander, Spain, 39008 | |
Sponsors and Collaborators
Trius Therapeutics, Inc.
Investigators
| Study Director: | Philippe G Prokocimer, MD | Trius Therapeutics |
More Information
No publications provided
| Responsible Party: | Trius Therapeutics, Inc. |
| ClinicalTrials.gov Identifier: | NCT01421511 History of Changes |
| Other Study ID Numbers: | TR701-113 |
| Study First Received: | August 19, 2011 |
| Last Updated: | January 30, 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 May 23, 2013