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

Skin and Subcutaneous Tissue Bacterial Infections Clinical Trial

— ABSSSI  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01170221
• Other study ID #: 1986-009
• Secondary ID: TR701-112
• Status: Completed
• Phase: Phase 3
• Start date: August 15, 2010
• Est. completion date: September 30, 2011

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 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 667
• Est. completion date: September 30, 2011
• Est. primary completion date: September 30, 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Drug:
• TR-701 FA
Oral TR-701 FA 200 mg once daily for six days followed by four days of placebo.
• Linezolid
Oral Linezolid 600 mg twice daily for 10 days

Locations

Country	Name	City	State
Argentina	Trius investigator site 307	Avellaneda	Pcia Buenos Aires
Argentina	Trius investigator site 309	Buenos Aires
Argentina	Trius investigator site 310	Buenos Aires
Argentina	Trius investigator site 300	Cordoba
Argentina	Trius Investigator site 301	Cordoba
Argentina	Trius investigator site 305	Córdoba
Argentina	Trius investigator site 304	Loma Hermosa	Pcia Buenos Aires
Argentina	Trius investigator site 308	Parana
Argentina	Trius investigator site 303	Rosario
Argentina	Trius investigator site 306	Santa Fe
Brazil	Trius investigator site 322	Barro Preto	Belo Horizonte
Brazil	Trius investigator site 320	Belo Horizonte
Brazil	Trius investigator site 321	São José do Rio Preto	SP
Brazil	Trius investigator site 323	Sao Paulo	SP
Canada	Trius investigator site 175	Brownsburg	Quebec
Canada	Trius investigator site 173	Chicoutimi	Quebec
Canada	Trius investigator site 171	Hamilton	Ontario
Canada	Trius investigator site 172	Hamilton	Ontario
Canada	Trius investigator site 174	Sherbrooke	Quebec
Canada	Trius investigator site 170	Winnipeg	Manitoba
Czechia	Trius investigator site 234	Hradec Kralove
Czechia	Trius investigator site 235	Melnik
Czechia	Trius investigator site 233	Ostrava
Czechia	Trius investigator site 236	Pardubice
Czechia	Trius investigator site 231	Prague
Germany	Trius investigator site 201	Berlin
Germany	Trius investigator site 202	Hanau
Germany	Trius investigator site 200	Mannheim
Germany	Trius investigator site 203	Plauen
Hungary	Trius investigator site 241	Debrecen
Hungary	Trius investigator site 242	Komló
Hungary	Trius investigator site 240	Szeged
Latvia	Trius investigator site 258	Daugavpils
Latvia	Trius investigator site 256	Liepaja
Latvia	Trius investigator site 257	Rezekne
Latvia	Trius investigator site 255	Riga
Peru	Trius investigator site 340	Arequipa
Peru	Trius investigator site 343	Cercado De Lima	Lima
Peru	Trius investigator site 342	Miraflores	Lima
Peru	Trius investigator site 341	San Juan de Miraflores	Lima
Slovakia	Trius investigator site 251	Banská Bystrica
Slovakia	Trius investigator site 250	Martin
Ukraine	Trius investigator site 271	Cherkassy
Ukraine	Trius investigator site 263	Dnepropetrovsk
Ukraine	Trius investigator site 264	Dnepropetrovsk
Ukraine	Trius investigator site 269	Ivano-Frankivsk
Ukraine	Trius investigator site 260	Kharkiv
Ukraine	Trius investigator site 261	Kyiv
Ukraine	Trius investigator site 265	Lviv
Ukraine	Trius investigator site 268	Lviv
Ukraine	Trius Investigator site 270	Ternopil
Ukraine	Trius investigator site 266	Uzhgorod
Ukraine	Trius investigator site 262	Zaporizhzhya
Ukraine	Trius investigator site 267	Zhytomyr
United States	Trius investigator site 118	Anaheim	California
United States	Trius Investigator site 130	Anaheim	California
United States	Trius investigator site 129	Buena Park	California
United States	Trius investigator site 133	Butte	Montana
United States	Trius Investigator site 116	Chicago	Illinois
United States	Trius Investigator Site 103	Chula Vista	California
United States	Trius investigator site 101	Columbus	Georgia
United States	Trius Investigator Site 107	Detroit	Michigan
United States	Trius investigator site 109	Dothan	Alabama
United States	Trius investigator site 112	Evansville	Indiana
United States	Trius investigator site 127	Fort Lauderdale	Florida
United States	Trius investigator site 135	Hialeah	Florida
United States	Trius investigator site 120	Houston	Texas
United States	Trius Investigator site 121	Houston	Texas
United States	Trius investigator site 122	Houston	Texas
United States	Trius investigator site 131	Houston	Texas
United States	Trius Investigator Site 105	La Mesa	California
United States	Trius investigator site 126	Laguna Beach	California
United States	Trius investigator site 128	Las Vegas	Nevada
United States	Trius investigator site 125	Norwalk	California
United States	Trius Investigator Site 104	Oceanside	California
United States	Trius investigator site 113	Oxnard	California
United States	Trius investigator site 123	Pasadena	California
United States	Trius Investigator Site 106	Rolling Hills Estates	California
United States	Trius Investigator Site 102	Savannah	Georgia
United States	Trius investigator site 115	Somers Point	New Jersey
United States	Trius Investigator Site 108	Springfield	Illinois
United States	Trius investigator site 114	Toledo	Ohio
United States	Trius investigator site 111	Torrance	California
United States	Trius investigator site 132	Torrance	California

Sponsors (1)

Lead Sponsor	Collaborator
Trius Therapeutics LLC

Countries where clinical trial is conducted

United States,  Argentina,  Brazil,  Canada,  Czechia,  Germany,  Hungary,  Latvia,  Peru,  Slovakia,  Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Early Clinical Response Rate	Responder: No increase in lesion surface area from baseline and oral temperature =37.6°C	48-72 hours
Secondary	Clinical Response at 48-72 Hours That is Sustained at the End of Therapy Visit.	Responder: No increase in lesion surface area from baseline and oral temperature =37.6°C.	Day 11
Secondary	Clinical Response at 48-72 Hours That is Sustained at the End of Therapy Visit in the Clinically Evaluable-End of Therapy Analysis Sets	Responder: No increase in lesion surface area from baseline and oral temperature =37.6°C	EOT Day 11
Secondary	Investigator's Assessment of Clinical Success at the Post Treatment Evaluation Visit	Clinical success defined as resolution/near resolution of most disease-specific signs and symptoms, absence/near resolution of systemic signs of infection, if present at baseline, no new signs, symptoms, or complications attributable to the ABSSSIs so no further antibiotic therapy was required for the treatment of the primary lesion.	Post-Treatment Evaluation (7-14 days after the End of Therapy)
Secondary	To Compare the Investigator's Assessment of Clinical Success at the Post Treatment Evaluation Visit in the Clinically Evaluable-Post Treatment Evaluation Analysis Set	Clinical success defined as resolution/near resolution of most disease-specific signs and symptoms, absence/near resolution of systemic signs of infection, no new signs, symptoms, or complications attributable to the ABSSSIs so no further antibiotic therapy was required for the treatment of the primary 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 was defined as improvement in overall clinical status.	48-72 Hour Visit
Secondary	Investigator's Assessment of Clinical Response at the Day 7 Visit	Clinical improvement was 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