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



Status:Completed
Conditions:Infectious Disease
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:18 - Any
Updated:8/31/2018
Start Date:September 15, 2011
End Date:January 10, 2013

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Trial Summary
Trial Overview
Inclusion Criteria

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

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.

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).

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
We found this trial at
35
sites
Trius investigator site 147
Teaneck, New Jersey 07666
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Teaneck, NJ
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Trius investigator site 150
Baton Rouge, Louisiana 70809
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Baton Rouge, LA
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Trius investigator site 154
Boston, Massachusetts 02115
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Boston, MA
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Trius investigator site 138
Carmel, Indiana 46032
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Carmel, IN
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Trius investigator site 103
Chula Vista, California 91911
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Chula Vista, CA
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Trius investigator site 352
Cludadela, Buenos Aires
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Cludadela,
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Trius investigator site 101
Columbus, Georgia 31904
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Columbus, GA
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Trius investigator site 140
Columbus, Ohio 43215
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Columbus, OH
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Trius investigator site 164
Creve Coeur, Missouri 63141
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Creve Coeur, MO
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Trius investigator site 139
Denver, Colorado 80218
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Denver, CO
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Trius investigator site 159
Dothan, Alabama 36305
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Dothan, AL
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Trius investigator site 166
Edgewater, Florida 32132
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Edgewater, FL
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Trius investigator site 143
Escondido, California 92025
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Escondido, CA
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Trius investigator site 165
Eunice, Louisiana 70535
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Eunice, LA
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Trius investigator site 155
Franklin, Tennessee 37064
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Franklin, TN
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Trius investigator site 148
Houston, Texas 77030
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Houston, TX
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Trius investigator site 105
La Mesa, California 91942
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La Mesa, CA
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Trius investigator site 160
Las Vegas, Nevada 89169
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Las Vegas, NV
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Trius investigator site 162
Lima, Ohio 45801
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Lima, OH
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Trius investigator site 106
Long Beach, California 90813
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Long Beach, CA
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Trius investigator site 145
Memphis, Tennessee 38104
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Memphis, TN
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Trius investigator site 153
Minneapolis, Minnesota 55415
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Minneapolis, MN
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Trius investigator site 142
National City, California 91950
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National City, CA
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Trius investigator site 137
Newark, Delaware 19718
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Newark, DE
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Trius investigator site 144
Owensboro, Kentucky 42303
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Owensboro, KY
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Trius investigator site 149
Picayune, Mississippi 39466
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Picayune, MS
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Trius investigator site 161
Rapid City, South Dakota 57702
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Rapid City, SD
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Trius investigator site 163
Royal Oak, Michigan 48073
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Royal Oak, MI
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Trius investigator site 170
San Diego, California 92123
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San Diego, CA
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Trius investigator site 167
Santa Ana, California 92701
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Santa Ana, CA
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Trius investigator site 169
Smyrna, Tennessee 37167
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Smyrna, TN
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Trius investigator site 146
Springfield, Massachusetts 01199
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Springfield, MA
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Trius investigator site 168
Stockton, California 95204
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Stockton, CA
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Trius investigator site 141
Sylmar, California 91342
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Sylmar, CA
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Trius investigator site 136
West Roxbury, Massachusetts 02132
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West Roxbury, MA
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