title: 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.affiliation: Cempra Pharmaceuticals, Chapel Hill, North Carolina, USA. j.c.craft@att.net
authors.forename: J Carl
authors.initials: JC
authors.lastname: Craft
authors.forename: Susan R
authors.initials: SR
authors.lastname: Moriarty
authors.forename: Kay
authors.initials: K
authors.lastname: Clark
authors.forename: Drusilla
authors.initials: D
authors.lastname: Scott
authors.forename: Thorsten P
authors.initials: TP
authors.lastname: Degenhardt
authors.forename: J Gordon
authors.initials: JG
authors.lastname: Still
authors.forename: G Ralph
authors.initials: GR
authors.lastname: Corey
authors.forename: Anita
authors.initials: A
authors.lastname: Das
authors.forename: Prabhavathi
authors.initials: P
authors.lastname: Fernandes
mesh_terms: D000081:Acetamides / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D000208:Acute Disease; D000284:Administration, Oral; D000328:Adult; D000900:Anti-Bacterial Agents / Q000008:administration & dosage / Q000009:adverse effects* / Q000494:pharmacology / Q000627:therapeutic use*; D002481:Cellulitis / Q000188:drug therapy / Q000382:microbiology; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005260:Female; D005672:Fusidic Acid / Q000008:administration & dosage / Q000009:adverse effects* / Q000627:therapeutic use*; D016908:Gram-Positive Bacterial Infections / Q000188:drug therapy / Q000382:microbiology; D006095:Gram-Positive Cocci / Q000187:drug effects*; D006801:Humans; D000069349:Linezolid; D008297:Male; D008875:Middle Aged; D023303:Oxazolidinones / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D017192:Skin Diseases, Bacterial / Q000188:drug therapy* / Q000382:microbiology; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D000081:Acetamides; D000900:Anti-Bacterial Agents; D023303:Oxazolidinones; D005672:Fusidic Acid; D000069349:Linezolid