Cefaclor advanced formulation 750 mg twice daily versus clarithromycin 500 mg twice daily in the treatment of acute maxillary sinusitis

Abstract

This multicenter, open-label, randomized, parallel-treatment, outpatient study compared the therapeutic equivalence and safety of cefaclor advanced formulation (AT) with those of clarithromycin in the treatment of acute maxillary sinusitis. Eligible patients were randomly allocated to receive cefaclor AT 750 mg twice daily for 10 days (n = 64) or clarithromycin 500 mg twice daily for 10 days (n = 65). A medical history was recorded, a physical examination was performed, and sinusitis diagnostic criteria (maxillofacial pain or tenderness, purulent rhinorrhea, headache, and fever) were assessed ≤24 hours before administration of the first dose of study medication (pretherapy). Assessments of symptomatic response, clinical response, and adverse events were performed 3 to 5 days after the end of therapy or at the time of early discontinuation (post therapy) and 10 to 14 days after the end of therapy (follow-up). Symptomatic responses of maxillofacial pain or tenderness, purulent rhinorrhea, and headache were scored on a 4-point scale (0 = absent, 1 = mild, 2 = moderate, and 3 = severe); clinical response was defined as cure, improvement, relapse, failure, or indeterminate. Treatment with cefaclor AF or clarithromycin almost eliminated maxillofacial pain and tenderness, purulent rhinorrhea, and headache. Mean symptom scores post therapy and at follow-up ranged from 0.1 to 0.3 in the cefaclor AF group and from 0.0 to 0.2 in the clarithromycin group. The incidence of treatment success was identical in the 2 treatment groups: 58 patients (91%) in the cefaclor AF group and 59 patients (91%) in the clarithromycin group were cured or improved post therapy. Twenty patients (31%) in the cefaclor AF group and 19 patients (29%) in the clarithromycin group experienced adverse events, none of which were serious. Discontinuations because of adverse events occurred in 4 patients in the clarithromycin group (gastrointestinal, 3; rash, 1) and 1 patient in the cefaclor AF group (rash); these differences were not statistically significant. In terms of clinical response and symptom score, cefaclor AF and clarithromycin were equally effective in the treatment of this group of patients with acute maxillary sinusitis.