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

Recruiting now · Not applicable · Has a placebo group

Conditions studied: Infectious Disease, Infections, Child, Only

In brief

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.

Key facts

Study ID: NCT06426147
Run by: Barcelona Institute for Global Health
People needed: 2200
Starts: 2025-12-08
Expected to finish: 2027-08-01
Last updated by the study team: 2026-02-23

Who can join

Age: any, up to 5. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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.

You may not qualify if…

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.

Where it is running

Hararghe Health Research — Harar, Ethiopia (enrolling)
Hospital Central de Maputo — Maputo, Mozambique (enrolling)

Full record on ClinicalTrials.gov

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