Efficacy and safety of cefdinir in the treatment of patients with acute bronchitis. The Cefdinir Bronchitis Study Group.

Author(s): Sperling MJ, Puopolo A, Griffin TJ, Keyserling CH, Tack KJ

Affiliation(s): Edinger Medical Group, Fountain Valley, California, USA.

Publication date & source: 1996-07, Clin Ther., 18(4):626-34.

Publication type: Clinical Trial; Multicenter Study; Randomized Controlled Trial

In this randomized, open-label, dose-comparative study, 18 investigators enrolled 466 patients with acute bronchitis. Patients were randomly assigned to receive either 600 mg of cefdinir once daily (QD) or 300 mg of cefdinir twice daily (BID) for 10 days. Both microbiologic and clinical efficacy were assessed at the test-of-cure visit, 7 to 14 days after therapy stopped. A total of 296 patients were classified as assessable at the test-of-cure visit (n = 150 QD, n = 146 BID). Eradication rates of baseline pathogens in these assessable patients were similar in both groups; the baseline pathogen eradication rate for assessable patients in the QD arm was 92%, and that in the BID arm was 93%. Clinical success (cure or improvement) in assessable patients was 91% and 93%, respectively. No difference was seen in the incidence of adverse events, in the incidence of diarrhea, or in the incidence of treatment withdrawals between the two groups. We conclude that cefdinir is effective and safe for the treatment of patients with acute bronchitis.