Journal of Antimicrobial Chemotherapy (2001) 47, 441-446
© 2001 The British Society for Antimicrobial Chemotherapy
Efficacy, safety and tolerability of 3 day azithromycin versus 10 day co-amoxiclav in the treatment of children with acute lower respiratory tract infections
a Department of Paediatrics, Sophia Children's Hospital/University Hospital, Rotterdam, The Netherlands; b Department of Epidemiology and Biostatistics, Erasmus University, Rotterdam, The Netherlands; c Juliana Children's Hospital, The Hague, The Netherlands; d Department of Paediatrics, 't Groene Hart Hospital, Gouda, The Netherlands; e Department of Paediatric Radiology, Sophia Children's Hospital/University Hospital, Rotterdam, The Netherlands
To compare the efficacy, safety and tolerability of a 3 day course of azithromycin with a 10 day course of co-amoxiclav in the treatment of children with acute lower respiratory tract infection (LRTI), 118 patients with community-acquired LRTI were included in a multicentre randomized double-blind, double-dummy study. The diagnosis of LRTI was based on the presence of respiratory signs and symptoms in combination with consolidation on a chest radiograph or clinical evidence of LRTI. Patients received oral azithromycin suspension (10 mg/kg/24 h) or placebo in one dose for 3 days and co-amoxiclav (45/11.25 mg/kg/24 h) or placebo in three doses for 10 days. Of 110 eligible patients, 56 and 54 patients, respectively, were treated with azithromycin or co-amoxiclav. The percentage of patients cured or clinically improved 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 not statistically significant (P = 0.55). Significantly (P = 0.01) more related adverse events were found in the co-amoxiclav group. This was largely due to a higher percentage (43% versus 19%) of gastrointestinal complaints. A 3 day course of azithromycin (three doses) is as effective in the treatment of LRTI in children as a 10 day course of co-amoxiclav (30 doses). The azithromycin group had fewer adverse events. We conclude that azithromycin is an effective, safe and well-tolerated drug in the treatment of children with LRTI. An additional advantage is the easy administration and short duration of therapy.
* Correspondence address. Sophia Children's Hospital, PO Box 2060, 3000 CB Rotterdam, The Netherlands. Tel: +31-10-4636104; Fax: +31-10-4636449; E-mail: rdegroot{at}alkg.azr.nl
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