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.
Publication types
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Clinical Trial, Phase II
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Comparative Study
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Multicenter Study
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Randomized Controlled Trial
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Research Support, Non-U.S. Gov't
MeSH terms
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Acetamides / administration & dosage
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Acetamides / adverse effects
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Acetamides / therapeutic use
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Acute Disease
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Administration, Oral
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Adult
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Anti-Bacterial Agents / administration & dosage
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Anti-Bacterial Agents / adverse effects*
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Anti-Bacterial Agents / pharmacology
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Anti-Bacterial Agents / therapeutic use*
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Cellulitis / drug therapy
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Cellulitis / microbiology
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Double-Blind Method
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Drug Administration Schedule
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Female
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Fusidic Acid / administration & dosage
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Fusidic Acid / adverse effects*
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Fusidic Acid / therapeutic use*
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Gram-Positive Bacterial Infections / drug therapy
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Gram-Positive Bacterial Infections / microbiology
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Gram-Positive Cocci / drug effects*
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Humans
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Linezolid
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Male
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Middle Aged
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Oxazolidinones / administration & dosage
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Oxazolidinones / adverse effects
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Oxazolidinones / therapeutic use
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Skin Diseases, Bacterial / drug therapy*
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Skin Diseases, Bacterial / microbiology
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Treatment Outcome
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Young Adult
Substances
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Acetamides
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Anti-Bacterial Agents
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Oxazolidinones
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Fusidic Acid
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Linezolid
Associated data
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ClinicalTrials.gov/NCT00948142