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.

Abstract

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.

• Authors: J Carl Craft, Susan R Moriarty, Kay Clark, Drusilla Scott, Thorsten P Degenhardt, J Gordon Still, G Ralph Corey, Anita Das, Prabhavathi Fernandes
• Journal: Clinical infectious diseases : an official publication of the Infectious Diseases Society of America (Clin Infect Dis) Vol. 52 Suppl 7 Pg. S520-6 (Jun 2011) ISSN: 1537-6591 [Electronic] United States
• PMID: 21546629 (Publication Type: Clinical Trial, Phase II, Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Acetamides
• Anti-Bacterial Agents
• Oxazolidinones
• Fusidic Acid
• Linezolid

Topics

• Acetamides (administration & dosage, adverse effects, therapeutic use)
• Acute Disease
• Administration, Oral
• Adult
• Anti-Bacterial Agents (administration & dosage, adverse effects, pharmacology, therapeutic use)
• Cellulitis (drug therapy, microbiology)
• Double-Blind Method
• Drug Administration Schedule
• Female
• Fusidic Acid (administration & dosage, adverse effects, therapeutic use)
• Gram-Positive Bacterial Infections (drug therapy, microbiology)
• Gram-Positive Cocci (drug effects)
• Humans
• Linezolid
• Male
• Middle Aged
• Oxazolidinones (administration & dosage, adverse effects, therapeutic use)
• Skin Diseases, Bacterial (drug therapy, microbiology)
• Treatment Outcome
• Young Adult