Actively Recruiting
L-citrulline to Improve Adverse Outcomes in Admitted Children (EChiLiBRiST, Clinical Trial 2, Inpatients)
Led by Barcelona Institute for Global Health · Updated on 2026-02-23
2200
Participants Needed
2
Research Sites
85 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
L-citrulline to Improve Adverse Outcomes in Admitted Children (EChiLiBRiST, Clinical Trial 2, Inpatients)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Enrolled in the initial prognostic screening component
- Sick children with fever (axillary temperature >37.5ºC) or history of fever within preceding 72 hours or with suspected severe disease
- Children aged 1 month to under 60 months
- Indication for hospital admission or already admitted due to illness
- sTREM-1 point-of-care result classifying disease as moderate-high risk (yellow or red) within 3 days of recruitment
- Residents in the study area or willing to be contacted and traced during the study
- Willing to sign informed consent
- Willing to adhere to study procedures as explained in the informed consent document
You will not qualify if you...
- Admission to hospital for social reasons only, not due to disease
- Informed consent not signed
- Known allergy or contraindication to study supplements including lactose intolerance or lactose-free diet
- Concurrent participation in any other clinical trial
- Patient under nothing by mouth (NPO) prescription
- Contraindication to nasogastric tube insertion or enteral drug administration through nasogastric tube
- Critically sick patient with prognosis considered fatal within hours after screening
- Any condition making it unlikely participant will complete follow-up until day 28
AI-Screening
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Trial Site Locations
Total: 2 locations
1
Hararghe Health Research
Harar, Ethiopia
Actively Recruiting
2
Hospital Central de Maputo
Maputo, Mozambique
Actively Recruiting
Research Team
Q
Quique Bassat, Prof
CONTACT
B
Barbara Baro, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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