Oral Sodium Fusidate (CEM-102) Versus Oral Linezolid for the Treatment of Acute Bacterial Skin and Skin Structure Infections

Study Overview
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Brief Summary
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Phase 3, randomized, double-blind, multi-center efficacy and safety study to evaluate an oral CEM-102 loading dose regimen compared to oral linezolid in the treatment of subjects with ABSSSI

Detailed Description
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The primary objective is to demonstrate the non-inferiority of oral CEM-102 (loading dose regimen of 1500 mg every 12 hours for 2 doses, followed by 600 mg every 12 hours thereafter) compared to oral linezolid (600 mg every 12 hours), each administered for 10 days, for Early Clinical Response (ECR) in the intent to treat (ITT) analysis set in subjects with acute bacterial skin and skin structure infections (ABSSSI). Subjects with an ABSSSI caused by suspected or documented Gram-positive pathogen(s) at baseline will be randomized 1:1 to study treatment

Official Title
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A Randomized, Double-blind, Multi-center Study to Evaluate the Safety and Efficacy of Oral Sodium Fusidate (CEM-102) Compared to Oral Linezolid in the Treatment of Acute Bacterial Skin and Skin Structure Infections

Conditions
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Acute Bacterial Skin and Skin Structure Infections

Intervention / Treatment
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* Drug: sodium fusidate
* Drug: linezolid


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adolescents between 12 to 18 years old must weigh >60 kg Patients diagnosed with ABSSSI with at least one systemic sign of infection Diagnosed with cellulitis, major cutaneous abscess, or wound infections (traumatic or surgical) Surface redness, edema or induration must be of a minimum surface area of 75 cm2, or extending ≥5 cm from the peripheral margin of the abscess Suspected or documented ABSSSI caused by a Gram-positive pathogen Exclusion Criteria: Involving a chronic diabetic foot infection (diabetic foot ulcer) Involving burns Involving an anatomical location (e.g. perirectal area) where the incidence of Gram-negative and/or anaerobic pathogen involvement is likely Documented bacteremia associated with the current ABSSSI Known severe renal impairment, as indicated by estimated CrCl <30 mL/min (by Cockcroft-Gault calculation) Evidence of significant liver disease: ALT >3x ULN, or direct bilirubin >ULN; known cirrhosis with decompensation (i.e. Child-Pugh Class B or C disease)

Ages Eligible for Study
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Minimum Age: 12 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: CEM-102 (Sodium fusidate)<br>1500 mg by mouth every 12 hours for 2 doses, then 600 mg by mouth every 12 hours thereafter, until end of therapy (10 days total) | Drug: sodium fusidate<br> <br> * Other names: CEM-102;|
| Active Comparator: Linezolid<br>600 mg by mouth every 12 hours for 10 days | Drug: linezolid<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of subjects with a response for Early Clinical Response | Proportion of subjects with a response for Early Clinical Response (ECR), defined as alive and achieved ≥ 20% reduction from baseline in the lesion size at 48-72 hours after start of study drug, without receipt of additional non-study antibiotic therapy. | 48 to 72 hours after starting treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of subjects with clinical success at Post-treatment Evaluation | Proportion of subjects with clinical success at PTE, in the ITT and clinically evaluable (CE) analysis sets. | 7 to 14 days after end of treatment | 
| Incidence of adverse events [Safety and tolerability], Clinical Laboratory Evaluations | Incidence of adverse events, vital sign changes, physical exam changes, and clinical laboratory evaluations will be presented by study arm | Up to 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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fusidic acid, skin infection