Infectious Disease

Optimizing place of treatment and antibiotic regimens for young infants presenting with signs of possible serious bacterial infection (PSBI)

Project Dates: 5/25/2020 – 06/30/2024

Principal Investigator: Christopher Sudfeld

The purpose of the project is to generate knowledge that will determine if it is possible to hospitalize only young infants with PSBI who need hospitalization and treat the others on an outpatient basis. In addition, the research will determine whether young infants with high-risk CSI who need hospitalization but improve early can be discharged early. These objectives will be completed through two trials, one among infants 0-59 days with low-mortality risk sign of CSI and one among infants -59 days with high- mortality risk sign of CSI.

This seven site randomized trial (Tanzania, Ethiopia, Nigeria, India, Pakistan, Bangladesh) coordinated by WHO will consist of two trials and an observational cohort. The first trial will examine the effect of hospital or outpatient treatment on mortality of young infants (1-59 days of age) with low-risk signs of clinical severe infection (CSI). The second trial will examine standard in-hospital care versus early discharge after 48 hours of treatment for young infants with high-mortality risk signs of CSI that resolve by 48 hours and have a negative CRP test. The project will also include a cohort of infants with critical illness who are not able to be randomized to home care. This study will inform WHO treatment guidelines for clinical severe infection.