1 research outputs found
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