Efficacy, safety and tolerability of 3 day azithromycin versus 10 day co-amoxiclav in the treatment of children with acute lower respiratory tract infections

To compare the efficacy, safety and tolerability of a 3 day course of azith romycin with a 10 day course of co-amoxiclav in the treatment of children w ith acute lower respiratory tract infection (LRTI), 118 patients with commu nity-acquired LRTI were included in a multicentre randomized double-blind, double-dummy study. The diagnosis of LRTI was based on the presence of resp iratory signs and symptoms in combination with consolidation on a chest rad iograph or clinical evidence of LRTI. Patients received oral azithromycin s uspension (10 mg/kg/24 h) or placebo in one dose for 3 days and co-amoxicla v (45/11.25 mg/kg/24 h) or placebo in three doses for 10 days. Of 110 eligi ble patients, 56 and 54 patients, respectively, were treated with azithromy cin or co-amoxiclav. The percentage of patients cured or clinically improve d at days 10-13 (primary endpoint) was 91% for azithromycin and 87% for co- amoxiclav. This difference of 4% (90% confidence interval: -6%, +14%) was n ot statistically significant (P = 0.55). Significantly (P = 0.01) move rela ted adverse events were found in the co-amoxiclav group. This was largely d ue to a higher percentage (43% versus 19%) of gastrointestinal complaints. A 3 day course of azithromycin (three doses) is as effective in the treatme nt of LRTI in children as a 10 day course of co-amoxiclav (30 doses). The a zithromycin group had fewer adverse events. We conclude that azithromycin i s an effective, safe and well-tolerated drug in the treatment of children w ith LRTI. An additional advantage is the easy administration and short dura tion of therapy.