Double-masked, randomized, parallel-group comparison of cefaclor af and cefaclor in the treatment of acute bacterial sinusitis

Abstract

A multicenter, randomized, double-masked, parallel-group study was conducted to compare the efficacy and safety of cefaclor AF (750 mg twice daily) and cefaclor (500 mg three times daily) in the treatment of 298 patients with acute bacterial sinusitis. Patients demonstrating a favorable clinical response 3 to 5 days posttherapy were reevaluated for relapse 10 to 14 days after therapy. At the posttherapy visit, there was a favorable clinical response (ie, cure/ improvement) in 91.8% of patients in the cefaclor AF group and in 92.9% of those in the cefaclor group. At the follow-up evaluation, only 1.8% of patients receiving cefaclor AF and 4.3% of those receiving cefaclor had relapsed. None of the between-group differences were statistically significant. The most common pathogens isolated were Streptococcus pneumoniae and Haemophilus influenzae. In patients with infections caused by S pneumoniae, 90.9% of those treated with cefaclor AF and 95.4% of those treated with cefaclor had a favorable clinical response at the posttherapy visit. In patients with infections caused by H influenzae, 90.9% of those treated with cefaclor AF and 77.8% of those treated with cefaclor had a favorable clinical response at the posttherapy visit. All patients infected by these pathogens were clinically cured at the follow-up visit. Both treatments were also highly effective in treating infections caused by Staphylococcus aureus, Moraxella catarrhalis, and Streptococcus pogenes. Both treatments were well tolerated, and there were no statistically significant differences between treatment groups in the frequency of adverse events. The only adverse events considered to be treatment related were diarrhea and abdominal pain. The results of this study demonstrate that the efficacy and safety of cefaclor AF are comparable with that of cefaclor in the treatment of patients with acute bacterial sinusitis