Abstract

ABSTRACTThe efficacy and safety of cefixime, the first oral third-generation cephalosporin, were evaluated in a multicenter clinical trial involving 118 adult patients with acute sinusitis or acute exacerbations of chronic sinusitis. Patients received a single daily dose of 400 mg of cefixime for a mean duration of 10 days; 106 patients completed a course of therapy. Clinical cure and improvement were achieved in 90% of these patients (61% cured and 29% improved). Among the patients evaluated again 2 weeks after therapy, 91% had a sustained clinical cure or improvement. Sinus exudate specimens were obtained from all patients by transantral puncture before therapy. Pathogens were isolated from 76 patients (66%), the most common pathogens being Haemophilus influenzae, α-hemolytic streptococci, and Streptococcus pneumoniae. Eighty-six percent of pathogens were presumed eradicated. Three patients discontinued therapy because of side effects. The most frequently reported adverse effects were gastrointestinal, with 20% of patients reporting diarrhea. Cefixime was effective in the treatment of bacterial sinus infections in adults and was well tolerated.