5 years ago

Comparable outcomes among trial and non-trial participants in a clinical trial of antibiotics for childhood pneumonia: A retrospective cohort study

We compared characteristics and outcomes of children enrolled in a randomized controlled trial (RCT) comparing oral amoxicillin and benzyl penicillin for the treatment of chest indrawing pneumonia versus children who received routine care to determine the external validity of the trial results. Study Design and Setting We undertook a retrospective cohort study of children aged 2 – 59 months admitted in six Kenyan hospitals. Data for non-trial participants were extracted from inpatient records upon conclusion of the RCT. Mortality among trial versus non-trial participants was compared in multivariate models. Results 1709 children were included, of whom 527 were enrolled in the RCT and 1182 received routine care. History of a wheeze was more common among trial participants (35.4% versus 11.2%; p<0.01), while dehydration was more common among non-trial participants (8.6% versus 5.9%; p=0.05). Other patient characteristics were balanced between the two groups. Among those with available outcome data, 14/1140 (1.2%) non-trial participants died compared to 4/527 (0.8%) enrolled in the trial (adjusted odds ratio 0.7; 95% confidence interval 0.2 to 2.1). Conclusion Patient characteristics were similar and mortality was low among trial and non-trial participants. These findings support the revised World Health Organization treatment recommendations for chest indrawing pneumonia.

Publisher URL: www.sciencedirect.com/science

DOI: S0895435616307739

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