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

Study Overview
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Brief Summary
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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

Detailed Description
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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.

Official Title
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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

Conditions
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Skin and Subcutaneous Tissue Bacterial Infections

Intervention / Treatment
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* Drug: TR-701 FA
* Drug: Linezolid


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TR-701 FA<br>TR0-701 FA 200 mg tablets once a day for six days followed by 4 days of placebo | Drug: TR-701 FA<br>* Oral TR-701 FA 200 mg once daily for six days followed by four days of placebo.<br>* Other names: TR-700 active moiety;|
| Active Comparator: Linezolid<br>Linezolid 600 mg tablets oral twice a day for 10 days | Drug: Linezolid<br>* Oral Linezolid 600 mg twice daily for 10 days<br>* Other names: Generic name = linezolid;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Early Clinical Response Rate | Responder: No increase in lesion surface area from baseline and oral temperature ≤37.6°C | 48-72 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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) | 
| 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) | 
| 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 | 
| Investigator's Assessment of Clinical Response at the Day 7 Visit | Clinical improvement was defined as improvement in overall clinical status. | Day 7 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ABSSSI, Tedizolid Phosphate, TR-701, Acute Bacterial Skin and Skin Structure Infections