NCT06426147 L-citrulline to Improve Adverse Outcomes in Admitted Children (EChiLiBRiST, Clinical Trial 2, Inpatients)

Eligibility & Interventions

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This trial targets 2,200 participants in total. It began in 2025-12-08 with a primary completion date of 2027-06-01.

Brief Summary

In low and middle-income countries, children admitted to hospital are not similarly ill, and do not all have a comparable prognosis. In fact, understanding at first encounter their risk of developing adverse outcomes (including mortality) could allow a more focused management and the tailoring of specific interventions to decrease in hospital mortality, and post discharge adverse longer-term outcomes. This clinical trial, part of the EChiLiBRiST larger project ("Development and validation of a quantitative point-of-care test for the measurement of severity biomarkers to improve risk stratification of fever syndromes and enhance child survival") has the two-fold objective of: 1. Assessing whether a POINT-OF-CARE rapid triaging test (PoC RTT) based on the quantitative measurement at the bedside of the "prognostic" biomarker sTREM-1 (soluble-triggering receptor expressed on myeloid cells 1) can reliably identify those admitted children with a higher risk of adverse outcomes; and 2. Assessing whether the therapeutic intervention (the L-arginine precursor, L-Citrulline, key in the nitric oxide biosynthesis), administered orally for 28 days to those children aged 1-\<60 months identified as "moderate-to-high risk" by the prognostic biomarker can improve outcomes as compared to those receiving an indistinguishable placebo. This second objective will be assessed in a prospective multi-country, multi-site, individually randomised, two-arm, placebo-controlled, double blind clinical trial involving \~888 children 1-\<60m of age admitted to hospital and determined to be at high risk of adverse outcomes by their baseline sTREM-1 levels. The trial will compare the efficacy of a twice-daily dose of L-citrulline syrup vs placebo (200-300mg/kg/day depending on weight-band; for 28 days) in reducing adverse outcomes in children with severe disease. The trial will be running independently but in parallel in two high-mortality settings in Mozambique and in Ethiopia.

Eligibility Criteria

Inclusion Criteria: * Enrolled in the initial prognostic screening component. * Sick children with fever (axillary temperature\>37.5ºC) or a history of fever (within the preceding 72h) or with suspected severe disease. * 1m-\<60 months of age. * With an indication for admission, or having already been admitted to hospital due to their illness. * With an sTREM-1 PoC result classifying their disease as of "moderate-high risk" ("yellow" or "red") upon study recruitment and within D3. * Residents in the study area or willing to be contacted and traced during the study duration. * Willing to sign an informed consent document. * Willing to undergo and adhere to study procedures as explained in the IC document. Exclusion Criteria: * Admission to hospital for social reasons (and not on account of their disease). * Children for which informed consent document has not been signed. * Known allergy or contraindication to any of the study supplements including lactose intolerance or observing a lactose-free diet. * Concurrent participation in any other clinical trial. * Patient under NPO or "nothing by mouth" prescription . * Contraindication for the insertion of a nasogastric tube (NGT) of for the enteral administration of drugs through the NGT in children who cannot tolerate by mouth. * Critically sick patient whose prognosis is considered by the clinical researcher as fatal outcome in the following hours after screening. * Any other condition determined by the investigators that makes it unlikely that the participant would complete the follow up until day 28 of study.

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