Inpatient versus outpatient management of young infants with a single low-mortality-risk sign of possible serious bacterial infection in sub-Saharan Africa and south Asia: an open-label, multicentre, two-arm, randomised controlled trial

BACKGROUND: Research has shown low mortality in young infants with a single low-mortality-risk possible serious bacterial infection (PSBI) sign. Outpatient treatment of young infants (age <2 months) with a single low-mortality-risk PSBI sign might be as effective and safe as hospitalisation. Outpatient treatment overcomes the challenges of hospitalisation and improves access in low-resource settings. Our aim was to assess clinical outcomes in patients with one low-mortality-risk PSBI sign treated as outpatients compared with inpatient treatment. METHODS: We did an open-label, multicentre, two-arm, randomised controlled trial at seven sites across Bangladesh, Ethiopia, India, Nigeria, Pakistan, and Tanzania. Young infants presenting to study hospitals with one of three low-mortality-risk PSBI signs (ie, fast breathing if age <7 days, body temperature ≥38°C, or…