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



Status:Recruiting
Conditions:Skin and Soft Tissue Infections, Infectious Disease
Therapuetic Areas:Dermatology / Plastic Surgery, Immunology / Infectious Diseases
Healthy:No
Age Range:12 - Any
Updated:6/15/2016
Start Date:November 2015
End Date:February 2017
Contact:Carrie McClung
Email:cmcclung@cempra.com

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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

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

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

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)
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