Cookies on this website

We use cookies to ensure that we give you the best experience on our website. If you click 'Accept all cookies' we'll assume that you are happy to receive all cookies and you won't see this message again. If you click 'Reject all non-essential cookies' only necessary cookies providing core functionality such as security, network management, and accessibility will be enabled. Click 'Find out more' for information on how to change your cookie settings.

OBJECTIVES: 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 vs. children who received routine care to determine the external validity of the trial results. STUDY DESIGN AND SETTING: A retrospective cohort study was conducted among children aged 2-59 months admitted in six Kenyan hospitals. Data for nontrial participants were extracted from inpatient records upon conclusion of the RCT. Mortality among trial vs. nontrial participants was compared in multivariate models. RESULTS: A total of 1,709 children were included, of whom 527 were enrolled in the RCT and 1,182 received routine care. History of a wheeze was more common among trial participants (35.4% vs. 11.2%; P < 0.01), while dehydration was more common among nontrial participants (8.6% vs. 5.9%; P = 0.05). Other patient characteristics were balanced between the two groups. Among those with available outcome data, 14/1,140 (1.2%) nontrial participants died compared to 4/527 (0.8%) enrolled in the trial (adjusted odds ratio, 0.7; 95% confidence interval: 0.2-2.1). CONCLUSION: Patient characteristics were similar, and mortality was low among trial and nontrial participants. These findings support the revised World Health Organization treatment recommendations for chest indrawing pneumonia.

Original publication




Journal article


J Clin Epidemiol

Publication Date





1 - 7


Acute respiratory infections, Amoxicillin, Benzyl penicillin, Clinical trial, External validity, Generalizability, World Health Organization, Amoxicillin, Anti-Bacterial Agents, Child, Preschool, Clinical Studies as Topic, Female, Humans, Infant, Kenya, Male, Mortality, Pneumonia, Randomized Controlled Trials as Topic, Retrospective Studies, Treatment Outcome