Short course therapy with ceftibuten versus azithromycin in pediatric streptococcal pharyngitis

Objective. To compare the safety and efficacy of a short course (5 days) of ceftibuten vs. azithromycin for 3 days for treatment of group A betahemoly tic streptococcal (GABHS) pharyngitis in children. Methods. A multicenter, open label, prospective, randomized trial in which patients greater than or equal to3 to less than or equal to 16 years of age with proven GABHS pharyngitis were randomized to receive either once daily ceftibuten for 5 days or azithromycin for 3 days. Patients were evaluated for clinical outcomes and/or for adverse events at days 6 to 8, 13 to 15 an d 33 to 35 posttherapy. Microbiologic assessments (pharyngeal cultures) wer e conducted at baseline and at each follow-up visit. Results. A total of 132 patients in the ceftibuten arm and 116 in the azith romycin arm were enrolled in the safety analysis, whereas 126 and 101, resp ectively, were enrolled for ceftibuten and azithromycin efficacy evaluation . Clinical success (cure or marked amelioration) at days 6 to 8 was recorde d in 98 and 94% in the 2 groups, respectively. In the bacteriologic efficac y analysis at 6 to 8 days, the GABHS strain was eradicated in 76% of the pa tients treated with ceftibuten and in 76% of those receiving azithromycin. At 33 to 35 days, 84% of the patients in the ceftibuten arm and 71% in the azithromycin arm were GABHS-negative, and bacteriologic relapse was observe d in 4 and 7% of the ceftibuten and azithromycin cases, respectively. Both treatments were well-tolerated by all patients. Conclusions. Ceftibuten and azithromycin allow simple treatment schedules ( i.e. once daily administration, short duration of treatment). The somewhat higher eradication rate recorded after ceftibuten administration is consist ent with the overall superior bactericidal activity of beta-lactams compare d with macrolides vs. GABHS in vitro.