RecruitingNot ApplicableNCT06422338

A Rapid Triage Test to Improve Risk-stratification of Febrile Children (EChiLiBRiST, Clinical Trial 1, Outpatients)

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


Sponsor

Barcelona Institute for Global Health

Enrollment

5,212 participants

Start Date

Jul 2, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 2 MonthsMax Age: 60 Months

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying IMCI-enhanced by suPAR levels (SoC + suPAR POC) for people with child, only, febrile illness, and other related conditions. The study is currently recruiting participants at 2 locations. People eligible for this study include aged 2 Months to 60 Months.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERIMCI-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

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NCT06422338


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