title: Comparative effectiveness and safety of cefdinir and amoxicillin-clavulanate in treatment of acute community-acquired bacterial sinusitis. Cefdinir Sinusitis Study Group.
abstract: Cefdinir is an extended-spectrum oral cephalosporin that is active against pathogens commonly seen in acute community-acquired bacterial sinusitis (ACABS), including Streptococcus pneumoniae, Haemophilus influenzae, and Moraxella catarrhalis. Two randomized, investigator-blind, multicenter trials (one in the United States and one in Europe) compared two dosage regimens of cefdinir (600 mg once a day for 10 days and 300 mg twice a day for 10 days) to amoxicillin-clavulanate (A-C) (500 mg three times a day for 10 days) for adult and adolescent patients with ACABS. Twelve hundred twenty-nine patients entered the U.S. study, 698 with antral puncture; 569 patients entered the European study, all with antral puncture. Clinical response (cure or improvement) was determined 7 to 14 days and 3 to 5 weeks posttherapy. Microbiologic eradication rates were determined 10 to 30 days posttherapy in a subset of patients who underwent pre- and posttherapy sinus aspirate culture. Rates of adverse events and treatment discontinuations due to adverse events were examined. Cefdinir, given once or twice daily, was as effective clinically (approximately 90% cure rate) as amoxicillin-clavulanate given three times daily in the treatment of ACABS. Microbiologic eradication rates were also similar in the three groups. The major side effect was mild diarrhea, occurring in approximately 20% of each group. Cefdinir caused fewer adverse events requiring treatment discontinuation.
authors.affiliation: Department of Internal Medicine, University of Virginia Health Science Center, Charlottesville 22908, USA.
authors.forename: J M
authors.initials: JM
authors.lastname: Gwaltney
authors.forename: S
authors.initials: S
authors.lastname: Savolainen
authors.forename: P
authors.initials: P
authors.lastname: Rivas
authors.forename: P
authors.initials: P
authors.lastname: Schenk
authors.forename: W M
authors.initials: WM
authors.lastname: Scheld
authors.forename: A
authors.initials: A
authors.lastname: Sydnor
authors.forename: C
authors.initials: C
authors.lastname: Keyserling
authors.forename: A
authors.initials: A
authors.lastname: Leigh
authors.forename: K J
authors.initials: KJ
authors.lastname: Tack
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000658:Amoxicillin / Q000009:adverse effects / Q000627:therapeutic use; D019980:Amoxicillin-Potassium Clavulanate Combination; D001424:Bacterial Infections / Q000188:drug therapy*; D000077525:Cefdinir; D002511:Cephalosporins / Q000009:adverse effects / Q000627:therapeutic use*; D002648:Child; D002969:Clavulanic Acids / Q000009:adverse effects / Q000627:therapeutic use; D017714:Community-Acquired Infections / Q000188:drug therapy*; D004334:Drug Administration Schedule; D004359:Drug Therapy, Combination / Q000009:adverse effects / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D008297:Male; D008826:Microbial Sensitivity Tests; D008875:Middle Aged; D016037:Single-Blind Method; D012852:Sinusitis / Q000188:drug therapy*; D016896:Treatment Outcome
chemical_list: D002511:Cephalosporins; D002969:Clavulanic Acids; D019980:Amoxicillin-Potassium Clavulanate Combination; D000658:Amoxicillin; D000077525:Cefdinir