Contezolid Acefosamil 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 contezolid acefosamil 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 Contezolid Acefosamil Compared to Linezolid Administered Intravenously and Orally to Adult Subjects With Acute Bacterial Skin and Skin Structure Infection

Conditions
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Skin Diseases, Bacterial, Gram-Positive Bacterial Infections

Intervention / Treatment
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* Drug: contezolid acefosamil
* Drug: linezolid 600 mg


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: contezolid acefosamil<br>contezolid acefosamil 1500 mg IV x 1 dose, followed by 1000 mg IV q12h for at least 3 total IV doses, followed by 1300 mg PO q12h for 10 to 14 days | Drug: contezolid acefosamil<br>* IV and oral contezolid acefosamil given twice a day for 10 to 14 days<br>|
| Active Comparator: linezolid<br>linezolid 600 mg IV q12h for at least 3 total IV doses, followed by 600 mg PO q12h for 10 to 14 days | Drug: linezolid 600 mg<br>* IV and oral linezolid given twice a day for 10 to 14 days<br>* Other names: Zyvox;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Early Clinical Response at the Early Assessment Visit (ITT Population) | Early clinical response assessment based on the electronic case report form (eCRF) data at Early Assessment (48-72 hours after start of study drug) where a successful response (i.e., responder) was defined as a reduction in primary ABSSSI lesion size ≥20% compared to baseline, and the subject did not receive a non-protocol specified systemic antibacterial agent with activity against Gram-positive organisms for the treatment of ABSSSI and did not die of any cause up to Early Assessment. | 48 to 72 hours after the start of study drug | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ABSSSI, Acute bacterial skin and skin structure infection