MRX-I Versus Linezolid for the Treatment of Acute Bacterial Skin and Skin Structure Infection

Study Overview
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Brief Summary
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The purpose of this study is to determine whether MRX-I is as safe and effective as Linezolid in the treatment of adult patients with acute bacterial skin and skin structure infections

Official Title
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A Phase 2, Multicenter, Randomized, Double-blind Study to Evaluate the Safety and Efficacy of MRX-I Versus Linezolid in Adult Subjects With Acute Bacterial Skin and Skin Structure Infection

Conditions
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Bacterial Infections

Intervention / Treatment
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* Drug: MRX-I
* 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 Prior systemic antibiotics within 96 hours of randomization

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MRX-I<br>MRX-I tablets 800 mg given twice a day for 10 days | Drug: MRX-I<br>* Oral MRX-I 800mg given twice a day for 10 days<br>|
| Active Comparator: Linezolid<br>Linezolid 600 mg given twice a day for 10 days | Drug: Linezolid<br>* Oral linezolid 600mg given twice a day for 10 days<br>* Other names: Zyvox;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients at the early assessment visit with a 20% reduction in ABSSSI lesion size compared to baseline | Did not receive a systemic antibacterial agent with activity against gram-positive organisms Did not die of any cause up to EA | 48-72 hours | 
| Number of patients with adverse events as a measure of safety and tolerability | Changes in vital signs, ECG parameters and laboratory data | Screening though Day 28 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of MITT patients at the early assessment visit with a 20% reduction in ABSSSI lesion size compared to baseline |  | 48-72 hours | 
| Number of patients at EOT with a 80% reduction in ABSSSI lesion size compared to baseline |  | Day 10 | 
| Number of patients with resolution or near resolution of most baseline ABSSSI symptoms and signs absence or near absence of systemic signs of infection at Post Trial Assessment |  | 7-14 days after the End of Therapy | 
| Number of patients with a microbiological outcome of eradication or presumed eradication at Post Trial Assessment |  | 7-14 days after the End of Therapy | 
| Population PK of MRX-I Tablets | • Influence of baseline subject characteristics on blood levels of MRX-I | Day 3 and Day 7 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ABSSSI, MRX-I, Acute Bacterial Skin and Skin Structure Infections