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.

Clinical and bacteriological efficacy of 5-day telithromycin in acute maxillary sinusitis: a pooled analysis

“…These rates are comparable with those observed with 10-day telithromycin and comparator antibacterials in this study and those that have been reported previously for b-lactam antibacterials and quinolones. 26,31,32 Only a small number of the S. pneumoniae strains isolated from patients in this analysis had decreased susceptibility to penicillin or macrolides (erythromycin), which makes evaluation difficult. However, a 5-day course of telithromycin achieved favourable clinical outcomes in patients infected with penicillin-or erythromycin-resistant pneumococci.…”

The microbiology and management of acute and chronic rhinosinusitis

“…In patients with acute community-acquired bacterial rhinosinusitis, Gwaltney and Savolainen [34] showed that ceftibuten (an extended-spectrum cephalosporin) was as effective in establishing a 90% cure rate as amoxicillin-clavulanate. Clement and de Gandt [35] evaluated the efficacy, tolerability, and safety of azithromycin and amoxicillin clavulanate in 354 patients with nonsevere acute maxillary and ethmoid sinusitis.…”

The diagnosis and management of sinusitis: A practice parameter update

“…Cefpodoxime and cefdinir are suitable agents. 237 There is theoretic concern regarding the 2 erythromycin analogues azithromycin and clarithromycin. Because both are relatively weak against penicillin-resistant H influenzae and S pneumoniae, this might lead to increasing resistance to macrolides.…”