A Randomized, Double-Blind Phase 2 Study Comparing the Efficacy and Safety of an Oral Fusidic Acid Loading-Dose Regimen to Oral Linezolid for the Treatment of Acute Bacterial Skin and Skin Structure Infections | Zendy

J. Carl Craft | Zendy; Susan Moriarty | Zendy; Kay Clark | Zendy; Drusilla Scott | Zendy; Thorsten P. Degenhardt | Zendy; James Still | Zendy; G. Ralph Corey | Zendy; Anita Das | Zendy; Prabhavathi Fernandes | Zendy

Open Access

A Randomized, Double-Blind Phase 2 Study Comparing the Efficacy and Safety of an Oral Fusidic Acid Loading-Dose Regimen to Oral Linezolid for the Treatment of Acute Bacterial Skin and Skin Structure Infections

Author(s) -

J. Carl Craft,

Susan Moriarty,

Kay Clark,

Drusilla Scott,

Thorsten P. Degenhardt,

James Still,

G. Ralph Corey,

Anita Das,

Prabhavathi Fernandes

Publication year - 2011

Publication title -

clinical infectious diseases

Language(s) - English

Resource type - Journals

SCImago Journal Rank - 3.44

H-Index - 336

eISSN - 1537-6591

pISSN - 1058-4838

DOI - 10.1093/cid/cir167

Subject(s) - medicine , fusidic acid , linezolid , tolerability , regimen , skin infection , cellulitis , staphylococcus aureus , antibiotics , antibacterial agent , randomized controlled trial , gastroenterology , adverse effect , surgery , microbiology and biotechnology , vancomycin , biology , bacteria , genetics

Fusidic acid (CEM-102), an orally bioavailable fusidane antibiotic with a unique mode of action, is under development for treatment of acute gram-positive bacterial skin and skin structure infections, including those caused by methicillin-susceptible and methicillin-resistant Staphylococcus aureus and streptococci. A phase 2, adaptive design, randomized, double-blind, multiple-center study of 198 adult patients with cellulitis or wound infections was conducted to evaluate an oral CEM-102 loading-dose regimen (1500 mg twice per day on day 1 followed by 600 mg twice per day) compared with oral linezolid (600 mg twice per day) administered for 10-14 days. The CEM-102 loading-dose regimen demonstrated efficacy, safety, and tolerability that was comparable to linezolid for the treatment of acute gram-positive bacterial skin and skin structure infections. Clinical Trials registration. NCT00948142.

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