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 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.
|Keywords||Amoxicillin-Potassium Clavulanate Combination/administration & dosage/*adverse effects/*therapeutic use, Anti-Bacterial Agents/administration & dosage/adverse effects/*therapeutic use, Azithromycin/administration & dosage/*adverse effects/*therapeutic use, Child, Child, Preschool, Comparative Study, Double-Blind Method, Drug Therapy, Combination/administration & dosage/adverse effects/*therapeutic use, Female, Humans, Infant, Male, Research Support, Non-U.S. Gov't, Respiratory Tract Infections/*drug therapy, Treatment Outcome|
Ferwerda, A., Moll, H.A., Hop, W.C.J., Kouwenberg, J.M., & Tjon Pian Gi, C.V.. (2001). Efficacy, safety and tolerability of 3 day azithromycin versus 10 day co-amoxiclav in the treatment of children with acute lower respiratory tract infections. Journal of Antimicrobial Chemotherapy. Retrieved from http://hdl.handle.net/1765/9620