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

Arrevus

Status and phase

Completed

Phase 3

Conditions

Acute Bacterial Skin and Skin Structure Infections

Treatments

Drug: sodium fusidate

Drug: linezolid

Study type

Interventional

Funder types

Industry

Identifiers

NCT02570490

CE06-301

Details and patient eligibility

About

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

Full 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

Enrollment

716 patients

Sex

All

Ages

12+ years old

Volunteers

No Healthy Volunteers

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)