Abstract :
Background
For most infections, especially acute respiratory infections (ARIs), the recommended duration of therapy is not based on strong scientific or clinical criteria. Shorter courses of antibiotics for non-severe pneumonia would result in lower costs, enhance patient compliance, and might help to contain antimicrobial resistance. We aimed to compare the clinical efficacy of 3-day and 5-day courses of amoxicillin in children with non-severe pneumonia.
Methods
We recruited 2000 children, aged 2–59 months, with non-severe pneumonia (WHO criteria) diagnosed in the outpatient departments of seven hospitals. Patients were randomly assigned to 3 days or 5 days of treatment with oral amoxicillin. The primary outcome was treatment failure. Analyses were by intention to treat.
Findings
We allocated 1000 children to 3 days of treatment and 1000 to 5 days. Treatment failed in 209 (21%) patients in the 3-day group, and in 202 (20%) in the 5-day group (difference 0•7%; 95% Cl−1•8 to 3•2). In 12 (1%) children in the 3-day group and in 13 (1%) in the 5-day group the disease relapsed (difference 0•1%; −0•6 to 0•8). Treatment was more likely to fail in children who did not adhere to treatment (p<0•0001), in those younger than 12 months (p<0•0001), in those whose illness lasted for 3 days or longer (p=0•004), in those whose respiratory rate was more than 10 breaths/min above the age-specific cut-off (p=0•004), and in those with vomiting (p=0•009). Non-adherence was also associated with failure of treatment in the 5-day group (p<0•0001).
Interpretation
Treatment with oral amoxicillin for 3-days was equally as effective as treatment for 5 days in children with non-severe pneumonia. The most important risk factor for treatment failure was non-compliance, which was also associated with longer duration of therapy.
Published online July 23, 2002 http://image.thelancet.com/extras/01art7461web.pdf
