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

Completed · Phase 3

Conditions studied: Acute Bacterial Skin and Skin Structure Infections

In brief

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

Key facts

Study ID

NCT02570490

Run by

Arrevus Inc.

People needed

716

Starts

2015-11-01

Expected to finish

2016-11-01

Last updated by the study team

2019-04-19

Who can join

Age: 12 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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)

Where it is running

• Study site — Bakersfield, California, United States
• Study site — Buena Park, California, United States
• Study site — Fountain Valley, California, United States
• Study site — La Mesa, California, United States
• Study site — La Palma, California, United States
• Study site — Long Beach, California, United States
• Study site — Los Angeles, California, United States
• Study site — Modesto, California, United States
• Study site — National City, California, United States
• Study site — Oceanside, California, United States
• Study site — Riverside, California, United States
• Study site — San Diego, California, United States
• Study site — San Diego, California, United States
• Study site — San Diego, California, United States
• Study site — San Diego, California, United States
• Study site — San Diego, California, United States
• Study site — San Dimas, California, United States
• Study site — Stockton, California, United States
• Study site — Sylmar, California, United States
• Study site — DeBary, Florida, United States
• Study site — DeLand, Florida, United States
• Study site — Doral, Florida, United States
• Study site — Doral, Florida, United States
• Study site — Hollywood, Florida, United States
• Study site — Anaheim, California, United States

Full record on ClinicalTrials.gov

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