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.
Journal Article (Journal Article;Multicenter Study)
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
- Clinical Infectious Diseases : an Official Publication of the Infectious Diseases Society of America
Volume / Issue
- 52 Suppl 7 /
Start / End Page
- S520 - S526
PubMed ID
- 21546629
Electronic International Standard Serial Number (EISSN)
- 1537-6591
Digital Object Identifier (DOI)
- 10.1093/cid/cir167
Language
- eng
Conference Location
- United States