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

AbstractBACKGROUND: 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% 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). 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.
AuthorsPakistan Multicentre Amoxycillin Short Course Therapy (MASCOT) pneumonia study group
JournalLancet (Lancet) Vol. 360 Issue 9336 Pg. 835-41 (Sep 14 2002) ISSN: 0140-6736 England
PMID12243918 (Publication Type: Clinical Trial, Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
Chemical References
  • Amoxicillin
Topics
  • Administration, Oral
  • Amoxicillin (administration & dosage)
  • Child, Preschool
  • Developing Countries
  • Double-Blind Method
  • Drug Administration Schedule
  • Female
  • Humans
  • Infant
  • Male
  • Patient Compliance
  • Pneumonia, Bacterial (drug therapy)
  • Treatment Failure
  • Treatment Outcome