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

Phase 3

Completed

• Conditions: Acute Bacterial Skin and Skin Structure Infections
• Interventions: Drug: sodium fusidate; Drug: linezolid

• Registration Number: NCT02570490
• Lead Sponsor: Arrevus Inc.

Brief Summary

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

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

Study Timeline

• Study First Submitted: 2015-10-05
• Study First Submitted QC: 2015-10-06
• Study First Posted: 2015-10-07
• Study Start: 2015-11
• Primary Completion: 2016-11
• Study Completion: 2016-11
• Disposition First Submitted: 2017-02-20
• Disposition First Submitted QC: 2017-02-20
• Disposition First Posted: 2017-02-23
• Status Verified: 2017-06
• Last Update Submitted: 2019-04-15
• Last Update Posted: 2019-04-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 716

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CEM-102 (Sodium fusidate)	sodium fusidate	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)
Linezolid	linezolid	600 mg by mouth every 12 hours for 10 days

Primary Outcome Measures

Name	Time	Method
Proportion of subjects with a response for Early Clinical Response	48 to 72 hours after starting treatment	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.

Secondary Outcome Measures

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