Clinical efficacy of 3 days versus 5 days of oral amoxicillin for treatment of childhood pneumonia: a multicentre double-blind trial.

Abstract

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. 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. 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% CI -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). 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.