How long should young infants less than two months of age with moderate-mortality-risk signs of possible serious bacterial infection be hospitalised for? Study protocol for a randomised controlled trial from low- and middle-income countries

Hospitalisation and a seven-day injectable antibiotics course are recommended by the World Health Organization (WHO) to treat suspected clinical neonatal sepsis / possible serious bacterial infection (PSBI). Some infants presenting with PSBI signs associated with a moderate risk of mortality may only need a two-day hospitalisation followed by outpatient care treatment with oral antibiotics to complete seven days of antibiotics. A multi-centre, individually randomised, open-label trial will be conducted in seven sites in six countries: Bangladesh, Ethiopia, India (two sites), Nigeria, Pakistan and Tanzania. A common protocol will be used with the same study design, including the participants, intervention, comparison, outcomes, quality control, and analysis procedures. 0-59 days old infants presenting with moderate-mortality risk signs (low body temperature (