OBJECTIVE. In settings with limited assessment tools, we sought to determine whether early clinical signs and symptoms and blood oxygen saturation would predict amoxicillin treatment failure in children with severe pneumonia (as defined by the World Health Organization).

METHODS. Data were from a previously reported, multinational trial of orally administered amoxicillin versus injectable penicillin for the treatment of World Health Organization–defined severe pneumonia in children 3 to 59 months of age. We assessed all 857 participants assigned randomly to the experimental amoxicillin arm. Six multivariate logistic regression models were created and evaluated for their ability to predict failure after 48 hours of therapy. Regression models included vital signs, symptoms, and laboratory data collected at baseline and after 12 or 24 hours of observation. Oxygen saturation data were included in 3 models.

RESULTS. Clinical treatment failure occurred for 18% of children. Younger age, increased initial respiratory rate, and baseline hypoxia predicted treatment failure in all models. Data available after 24 hours improved the ability to predict failure compared with data available at baseline or 12 hours. The inclusion of oximetry data improved the predictive ability at baseline, 12 hours, and 24 hours. The ability to predict failure after 12 hours of observation with oximetry data was similar to the predictive ability after 24 hours without pulse oximetry data.

CONCLUSIONS. Assessment of clinical parameters at presentation and after 24 hours improved the ability to predict clinical failure of oral amoxicillin therapy, compared with assessment at presentation alone or at presentation and after only 12 hours, for children with World Health Organization–defined severe pneumonia.

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