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

• Status: Completed
• Trial end date: 2016-11-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Arrevus Inc.; Cempra Inc
• Treatments: Fusidic Acid; Linezolid

Criteria

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)