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.

Published

Journal Article

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.

Full Text

Duke Authors

Cited Authors

  • Craft, JC; Moriarty, SR; Clark, K; Scott, D; Degenhardt, TP; Still, JG; Corey, GR; Das, A; Fernandes, P

Published Date

  • June 2011

Published In

Volume / Issue

  • 52 Suppl 7 /

Start / End Page

  • S520 - S526

PubMed ID

  • 21546629

Pubmed Central ID

  • 21546629

Electronic International Standard Serial Number (EISSN)

  • 1537-6591

International Standard Serial Number (ISSN)

  • 1058-4838

Digital Object Identifier (DOI)

  • 10.1093/cid/cir167

Language

  • eng