Three day versus five day treatment with amoxicillin for non-severe pneumonia in young children: a multicentre randomised controlled trial

• Published in: BMJ 2004-04, Vol.328 (7443), p.791-794
• Main Authors: Agarwal, Girdhar, Awasthi, Shally, Kabra, S K, Kaul, Annapurna, Singhi, Sunit, Walter, Stephen D
• Format: Article
• Language: English
• Subjects: Amoxicillin - administration & dosage; Amoxicillin - economics; Anti-Bacterial Agents - administration & dosage; Anti-Bacterial Agents - economics; Antibiotics; Child, Preschool; Children; Children & youth; Colleges & universities; Costs and Cost Analysis; Dosage; Double-Blind Method; Drug Administration Schedule; Experimentation; Failure; Health care costs; Humans; Hypotheses; Infant; Medical treatment failures; Patient Compliance; Pneumonia; Pneumonia, Bacterial - drug therapy; Pneumonia, Bacterial - economics; Relapse; Respiration; Respiratory rate; Risk Factors; Streptococcus infections; Treatment Outcome; Viruses
• ISSN: 0959-8138; 1468-5833; 1756-1833
• DOI: 10.1136/bmj.38049.490255.DE

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 enrolment, 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.