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A Rapid Triage Test to Improve Risk-stratification of Febrile Children (EChiLiBRiST, Clinical Trial 1, Outpatients)
Sponsor: Barcelona Institute for Global Health
Summary
The overall aim of the study is to provide evidence that introducing novel biomarkers evaluation at triaging (first clinical assessment), in combination with IMCI-based guidelines (SoC), is a viable strategy to enhance rapid and accurate identification of febrile children at increased risk of life-threatening infections compared to IMCI-based strategies alone (SoC), and to demonstrate whether this results in enhanced decisions of admission/referral vs discharge, and enhanced overall health outcome of children with acute fever in sub-Saharan Africa.
Official title: A Multi-country, Two-arm, Open-label, Superiority, Randomised Controlled Trial to Study the Performance of a Rapid Triage Test Compared to Standard of Care (IMCI-based) to Guide Admission/Discharge Decisions During the First Clinical Assessment of Children With Fever
Key Details
Gender
All
Age Range
2 Months - 60 Months
Study Type
INTERVENTIONAL
Enrollment
5212
Start Date
2025-07-02
Completion Date
2027-03-01
Last Updated
2026-02-17
Healthy Volunteers
No
Interventions
IMCI-enhanced by suPAR levels (SoC + suPAR POC)
IMCI-guidelines (standard of care) + Point-Of-Care (POC) based on suPAR quantification
Locations (2)
CERMEL Centre de Recherches Médicales de Lambaréné
Lambaréné, Moyen-Ogooué Province, Gabon
Mopeia Sede Health Centre
Mopeia, Mozambique