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

Sponsor
Barcelona Institute for Global Health
Study ID
NCT06426147
Status
Recruiting
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Conditions

  • Child, Only
  • Infections
  • Infectious Disease

Eligibility Criteria

Sex
ALL
Age
0 Months - 60 Months
Healthy Volunteers
Not accepted

Interventions

  • L-citrulline — DIETARY_SUPPLEMENT
    1 or 2 sachets every 12 hours (200-300mg/kg/day depending on weight-band) for 28 days
  • Placebo — DIETARY_SUPPLEMENT
    1 or 2 sachets every 12 hours (depending on weight-band) for 28 days

Study Details

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 Dates

First listed
May 23, 2024
Start date
Dec 8, 2025
Status verified
Feb 2026
Primary completion
Jun 1, 2027
Completion
Aug 1, 2027

Study Design

Enrollment
2,200 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: L-citrulline
    1 or 2 sachets every 12 hours (200-300mg/kg/day depending on weight-band) for 28 days
  • Placebo Comparator: Placebo
    1 or 2 sachets every 12 hours (depending on weight-band) for 28 days

Primary Outcome Measure

Adverse disease outcome [ Time Frame: Up to day 28 ]

Central Contacts

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