Evaluating a Rapid Blood Test with IMCI Guidelines to Improve Hospital Admission Decisions for Febrile Children Aged 2 to Under 5 Years in Sub-Saharan Africa

What this Trial Is About

Researchers are evaluating a new strategy to improve the rapid and accurate identification of febrile children aged 2 to under 5 years at risk of life-threatening infections in sub-Saharan Africa. The study compares the current standard of care using IMCI-based guidelines to a new method that adds a rapid point-of-care test measuring suPAR biomarker levels. The goal is to see if this combined approach leads to better decisions about hospital admission, referral, or discharge, and ultimately improves health outcomes. The trial involves two groups one receiving standard IMCI-based care and the other receiving IMCI-based care enhanced by suPAR testing. Blood samples will be taken from all children, but only those in the suPAR group will have their suPAR levels measured on-site using a special device. Decisions about admitting or discharging children during the first clinical assessment will be guided by these results, especially for those with higher suPAR levels indicating greater risk. A second clinical assessment by an independent physician will help ensure safety and confirm decisions. Participants will be monitored with follow-up visits on days 3 and 7 after enrollment, plus additional check-ins if their condition worsens. A 28-day follow-up interview will track serious events, hospitalizations, or deaths, with an optional 3-month follow-up for further health status updates. Throughout the study, children will receive routine treatments as needed. Researchers will measure the appropriateness of discharge decisions, hospital referrals, survival, symptom duration, and other health outcomes to assess the new triage method.

A Rapid Triage Test to Improve Risk-stratification of Febrile Children (EChiLiBRiST, Clinical Trial 1, Outpatients)