Author(s): Agarwal G, Awasthi S, Kabra SK, Kaul A, Singhi S,
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Abstract OBJECTIVE: To assess the efficacy of three days versus five days of treatment with oral amoxicillin for curing non-severe pneumonia in children. DESIGN: Randomised, double blind, placebo controlled multicentre trial. SETTING: Outpatient departments of seven referral hospitals in India. PARTICIPANTS: 2188 children aged 2-59 months, 1095 given three days of treatment and 1093 given five days. INTERVENTION: Oral amoxicillin 31-54 mg/kg/day in three divided doses. MAIN OUTCOME MEASURES: Treatment failure: defined as development of chest indrawing, convulsions, drowsiness, or inability to drink at any time; respiratory rate above age specific cut points on day 3 or later; or oxygen saturation by pulse oximetry < 90\% on day 3. RESULTS: The clinical cure rates with three days and five days of treatment were 89.5\% and 89.9\%, respectively (absolute difference 0.4 (95\% confidence interval--2.1 to 3.0)). Adherence to treatment regimen was 94\% and 85\% for three day and five day treatments, respectively. Loss to follow up was 5.4\% by day 5. There were no deaths, 41 hospitalisations, and 36 minor adverse reactions. There were 225 (10.3\%) clinical failures and 106 (5.3\%) relapses, and rates were similar in both treatments. At enrollment, 513 (23.4\%) children tested positive for respiratory syncytial virus, and Streptococcus pneumoniae and Haemophilus influenzae were isolated from the nasopharynx in 878 (40.4\%) and 496 (22.8\%) children, respectively. Clinical failure was associated with isolation of respiratory syncytial virus (adjusted odds ratio 1.95 (95\% confidence interval 1.0 to 3.8)), excess respiratory rate of > 10 breaths/minute (2.89 (1.83 to 4.55)), and non-adherence with treatment at day 5 (11.57 (7.4 to 18.0)). CONCLUSIONS: Treatment with oral amoxicillin for three days was as effective as for five days in children with non-severe pneumonia.
This article was published in BMJ
and referenced in Journal of Antimicrobial Agents