Trial of Oral L-Citrulline to Improve Outcomes in Hospitalized Children Aged 1 Month to Under 5 Years at High Risk of Severe Infection

What this Trial Is About

Researchers are investigating how a rapid bedside test measuring the biomarker sTREM-1 can identify hospitalized children at higher risk of serious health problems or death in low and middle-income countries. This study aims to see if this test can help guide treatment and improve survival and health after discharge. The trial is part of a larger project focused on improving outcomes for children with fever syndromes. The study involves children aged 1 month to under 5 years who are admitted to hospital and identified as moderate to high risk by the biomarker test. Participants are randomly assigned to receive either L-citrulline syrup, a supplement involved in nitric oxide production, or a placebo. The treatment is given twice daily by weight for 28 days. The trial is conducted in multiple sites in Mozambique and Ethiopia and uses a double-blind, placebo-controlled design. Participants will be followed for six months with visits at the hospital, home, or by phone on days 3, 5, 7, 28, and at 6 months. Researchers will monitor adverse outcomes including death, neurological problems, kidney events, organ support needs, shock, coma, respiratory distress, or hospital readmission within 28 days. Safety events and longer-term health after discharge will also be assessed to understand the treatments impact and overall child survival.

L-citrulline to Improve Adverse Outcomes in Admitted Children (EChiLiBRiST, Clinical Trial 2, Inpatients)