Condition: Infectious Disease · Infections · Child, Only · Sponsor: Barcelona Institute for Global Health
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 t…
This description comes directly from the study's public registry record.
Quique Bassat, Prof · 93 227 92 12 · quique.bassat@isglobal.org
Barbara Baro, PhD · 93 227 92 12 · barbara.baro@isglobal.org
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| Hararghe Health Research | Harar, Ethiopia | Recruiting |
| Hospital Central de Maputo | Maputo, Mozambique | Recruiting |
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Source record: clinicaltrials.gov/study/NCT06426147