title: Pharmacokinetically enhanced amoxicillin/clavulanate (2,000/125 mg) in acute bacterial rhinosinusitis caused by Streptococcus pneumoniae, including penicillin-resistant strains.
abstract: We evaluated the efficacy of a new pharmacokinetically enhanced formulation of amoxicillin/clavulanate (2,000/125 mg) twice daily for the treatment of acute bacterial rhinosinusitis (ABRS) caused by Streptococcus pneumoniae, particularly penicillin-resistant S pneumoniae (PRSP; penicillin minimum inhibitory concentrations [MICs]: > or = 2 microg/ml. A total of 2,482 patients received study medication (safety population). Of these, 2,324 were clinically evaluable (efficacy population), and 1,156 of them had at least one pathogen isolated at screening (bacteriology population). S pneumoniae was isolated from 371 patients in the bacteriology population, including 37 with PRSP. Follow-up in the bacteriology population on days 17 through 28 revealed that amoxicillin/clavulanate therapy was successful in 345 of 371 patients with S pneumoniae infection (93.0%) and in 36 of 37patients with PRSP infection (97.3%), including 7 of 8 patients (87.5%) whose amoxicillin/clavulanic acid MICs were 4/2 microg/ml or higher. Pharmacokinetically enhanced amoxicillin/clavulanate was generally well tolerated, as only 2.2% of patients withdrew because of adverse events. This agent represents a valuable new therapeutic option for the empiric treatment of ABRS, particularly in areas where antimicrobial-resistant pathogens (including beta-lactamase-positive organisms) are prevalent, and for the treatment of patients who are at increased risk of infection with PRSP.
authors.affiliation: Department of Otolaryngology, University of Pittsburgh College of Medicine, PA, USA. janonmd@velocity.net
authors.forename: Jack B
authors.initials: JB
authors.lastname: Anon
authors.forename: Berrylin
authors.initials: B
authors.lastname: Ferguson
authors.forename: Monique
authors.initials: M
authors.lastname: Twynholm
authors.forename: Brian
authors.initials: B
authors.lastname: Wynne
authors.forename: Elchonon
authors.initials: E
authors.lastname: Berkowitz
authors.forename: Michael D
authors.initials: MD
authors.lastname: Poole
mesh_terms: D000208:Acute Disease; D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000658:Amoxicillin / Q000008:administration & dosage / Q000494:pharmacology / Q000627:therapeutic use*; D000900:Anti-Bacterial Agents / Q000008:administration & dosage / Q000494:pharmacology / Q000627:therapeutic use*; D019818:Clavulanic Acid / Q000008:administration & dosage / Q000494:pharmacology / Q000627:therapeutic use*; D004359:Drug Therapy, Combination; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D010403:Penicillin Resistance; D018570:Risk Assessment; D012852:Sinusitis / Q000188:drug therapy* / Q000382:microbiology; D013290:Streptococcal Infections / Q000188:drug therapy* / Q000382:microbiology; D013296:Streptococcus pneumoniae / Q000187:drug effects* / Q000302:isolation & purification; D016896:Treatment Outcome
chemical_list: D000900:Anti-Bacterial Agents; D019818:Clavulanic Acid; D000658:Amoxicillin