TR-701 FA vs Linezolid for the Treatment of Acute Bacterial Skin and Skin Structure Infections

Skin and Subcutaneous Tissue Bacterial Infections Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01421511
• Other study ID #: 1986-010
• Secondary ID: TR701-113
• Status: Completed
• Phase: Phase 3
• Start date: September 15, 2011
• Est. completion date: January 10, 2013

Study information

• Verified date: July 2018
• Source: Trius Therapeutics LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 666
• Est. completion date: January 10, 2013
• Est. primary completion date: January 10, 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bacterial Infections
• Communicable Diseases
• Infection
• Skin and Subcutaneous Tissue Bacterial Infections

Intervention

Drug:
• TR-701 FA
TR-701 FA 200 mg once daily in 250 mL sterile saline for injection as a 60 minute IV infusion TR-701 FA Tablets, 200 mg, orally once daily
• Linezolid
Linezolid 600 mg IV Injection twice daily in 300 mL sterile saline for injection as a 60 minute IV infusion Linezolid Tablets, 600 mg, orally every 12 hours

Locations

Country	Name	City	State
Argentina	Trius investigator site 354	Buenos Aires
Argentina	Trius investigator site 355	Buenos Aires
Argentina	Trius investigator site 351	Cludad Autonoma De Buenos Aires
Argentina	Trius investigator site 352	Cludadela	Buenos Aires
Argentina	Trius investigator site 354	General Roriquez	Buenos Aires
Argentina	Trius investigator site 350	La Plata	Buenos Aires
Argentina	Trius investigator site 350	La Plata	Buenos Aires
Argentina	Trius investigator site 358	La Plata
Argentina	Trius investigator site 353	Lujan	Buenos Aires
Argentina	Trius investigator site 357	Mar del Plata
Argentina	Trius investigator site 359	Paraná, Entre Rios
Argentina	Trius investigator site 356	Rosario
Australia	Trius investigator 500	Cairns	Queensland
Australia	Trius investigator 501	Herston	Queensland
Australia	Trius investigator 503	Nambour	Queensland
Australia	Trius investigator 505	Richmond	Victoria
Australia	Trius investigator 506	Southport	Queensland
Australia	Trius investigator 502	Woolloongabba	Queensland
Australia	Trius investigator 504	Woolloongabba	Queensland
Brazil	Trius investigator site 361	Belo Horizonte
Brazil	Trius investigator site 361	Belo Horizonte	MG, Brazil
Brazil	Trius investigator site 362	Belo Horizonte	MG, Brazil
Brazil	Trius investigator site 362	Belo Horizonte
Brazil	Trius investigator site 365	Belo Horizonte
Brazil	Trius investigator site 364	Campinas
Brazil	Trius investigator site 364	Campinas	SP, Brazil
Brazil	Trius investigator site 366	Curitiba
Brazil	Trius investigator site 367	Curitiba
Brazil	Trius investigator site 369	Jaú
Brazil	Trius investigator site 363	Porto Alegre
Brazil	Trius investigator site 363	Porto Alegre	RS, Brazil
Brazil	Trius investigator site 370	Porto Alegre
Brazil	Trius investigator site 360	São Paulo
Germany	Trius investigator site 207	Berlin
Germany	Trius investigator site 208	Dresden	Sachsen
Germany	Trius investigator site 205	Hamburg
Germany	Trius investigator site 204	Luebeck	Schleswig-Holstein
Germany	Trius investigator site 206	Quedlinburg	Sachsen-Anhalt
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
New Zealand	Trius investigator 521	Otahuhu	Auckland
New Zealand	Trius investigator 520	Sydenham	Christchurch
Poland	Trius investigator site 216	Bydgoszcz
Poland	Trius investigator site 211	Lodz
Poland	Trius investigator site 214	Lublin
Poland	Trius investigator site 213	Poznan
Poland	Trius investigator site 215	Szczecin
Poland	Trius investigator site 212	Warszawa
Russian Federation	Trius investigator site 287	Barmaul
Russian Federation	Trius investigator site 286	Irkutsk
Russian Federation	Trius investigator site 293	Lipetsk
Russian Federation	Trius investigator site 288	Moscow
Russian Federation	Trius investigator site 290	Moscow
Russian Federation	Trius investigator site 291	Moscow
Russian Federation	Trius investigator site 295	Moscow
Russian Federation	Trius investigator site 285	Novosibirsk
Russian Federation	Trius investigator site 297	Novosibirsk
Russian Federation	Trius investigator site 289	Saint-Petersburg
Russian Federation	Trius investigator site 294	saint-Petersburg
Russian Federation	Trius investigator site 296	Saint-Petersburg
Russian Federation	Trius investigator site 289	St-Petersburg
Russian Federation	Trius investigator site 298	Tomsk
Russian Federation	Trius investigator site 292	Vsevolozhsk	Leningrad Region
South Africa	Trius investigator site 445	Benoni
South Africa	Trius investigator site 442	Bloemfontein	Free States
South Africa	Trius investigator site 441	Blowmfontein	Free States
South Africa	Trius investigator 447	Breyten	Mpunalanga
South Africa	Trius investigator 451	Centurion	Gauteng
South Africa	Trius investigator 448	Dundee	Kwa Zulu Natal
South Africa	Trius investigator site 440	Gezina Pretoria	Gauteng
South Africa	Trius investigator 446	Middelburg	Mpumalanga
South Africa	Trius investigator 443	Port Elizabeth	Eastern Cape
South Africa	Trius investigator 449	Pretoria	Gauteng
South Africa	Trius investigator 450	Pretoria	Gauteng
South Africa	Trius investigator 444	Worscester	Cape
Spain	Trius investigator site 272	Alcorcon	Madrid
Spain	Trius investigator site 277	Baracaldo	Vizcaya
Spain	Trius investigator site 276	Madrid
Spain	Trius investigator site 275	Majadahonda	Madrid
Spain	Trius investigator site 273	Mataro	Barcelona
Spain	Trius investigator site 274	Santander
United States	Trius investigator site 150	Baton Rouge	Louisiana
United States	Trius investigator site 154	Boston	Massachusetts
United States	Trius investigator site 138	Carmel	Indiana
United States	Trius investigator site 103	Chula Vista	California
United States	Trius investigator site 101	Columbus	Georgia
United States	Trius investigator site 140	Columbus	Ohio
United States	Trius investigator site 164	Creve Coeur	Missouri
United States	Trius investigator site 139	Denver	Colorado
United States	Trius investigator site 159	Dothan	Alabama
United States	Trius investigator site 166	Edgewater	Florida
United States	Trius investigator site 143	Escondido	California
United States	Trius investigator site 165	Eunice	Louisiana
United States	Trius investigator site 155	Franklin	Tennessee
United States	Trius investigator site 148	Houston	Texas
United States	Trius investigator site 105	La Mesa	California
United States	Trius investigator site 160	Las Vegas	Nevada
United States	Trius investigator site 162	Lima	Ohio
United States	Trius investigator site 106	Long Beach	California
United States	Trius investigator site 157	Long Beach	California
United States	Trius investigator site 145	Memphis	Tennessee
United States	Trius investigator site 153	Minneapolis	Minnesota
United States	Trius investigator site 142	National City	California
United States	Trius investigator site 137	Newark	Delaware
United States	Trius investigator site 144	Owensboro	Kentucky
United States	Trius investigator site 149	Picayune	Mississippi
United States	Trius investigator site 161	Rapid City	South Dakota
United States	Trius investigator site 163	Royal Oak	Michigan
United States	Trius investigator site 170	San Diego	California
United States	Trius investigator site 167	Santa Ana	California
United States	Trius investigator site 169	Smyrna	Tennessee
United States	Trius investigator site 146	Springfield	Massachusetts
United States	Trius investigator site 168	Stockton	California
United States	Trius investigator site 141	Sylmar	California
United States	Trius investigator site 147	Teaneck	New Jersey
United States	Trius investigator site 136	West Roxbury	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Trius Therapeutics LLC

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Brazil,  Germany,  Mexico,  New Zealand,  Poland,  Russian Federation,  South Africa,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Early Clinical Response Rate	Responder: No increase in lesion surface area from baseline.	48-72 hours
Secondary	Clinical Response at the End of Therapy Visit	Responder: No increase in lesion surface area from baseline.	Day 11
Secondary	Clinical Response at the End of Therapy Visit in the Clinically Evaluable at End of Therapy Analysis Set	Responder: No increase in lesion surface area from baseline.	End of Therapy Day 11
Secondary	Investigator's Assessment of Clinical Success at the Post Treatment Evaluation Visit	Clinical success defined as resolution/near resolution of disease specific signs and symptoms, absence/near resolution of baseline systemic signs of infection, and no further antibiotic therapy required for treatment of primary ABSSSI lesion.	Post-Treatment Evaluation (7-14 days after the End of Therapy)
Secondary	Investigator's Assessment of Clinical Success of the Post Therapy Evaluation Visit in Clinically Evaluable-Post Treatment Evaluation Analysis Set.	Clinical success defined as resolution/near resolution of disease specific signs and symptoms, absence/near resolution of baseline systemic signs of infection, no new signs, symptoms or complications attributable to the ABSSSI and no further antibiotic therapy required for treatment of primary ABSSSI lesion.	Post-Treatment Evaluation (7-14 days after the End of Therapy)
Secondary	Investigator's Assessment of Clinical Response at the 48-72 Hour Visit	Clinical improvement defined as improvement in overall clinical status.	48-72 Hours
Secondary	Investigator's Assessment of Clinical Response at the Day-7 Visit	Clinical improvement defined as improvement in overall clinical status.	Day 7
Secondary	Change From Baseline in Patient-reported Pain, by Study Visit	0=no pain, 10=worst pain Only 1 visit per participant for Day 4-6, only 1 visit for Day 7-9, and only 1 visit for Day 10-13.	Multiple