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

RecruitingNAAges 2 Months - 60 MonthsAllBarcelona Institute for Global Health
NCT06422338 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
Inclusion Criteria: * Age ≥2 months and \<60 months * Written informed consent from the child's parent or caregiver * History of fever for ≤7 days OR hypothermia (i.e., axillary temperature \<35.5ºC) OR suspected severe infection (e.g., in children with moderate or severe acute malnutrition). * Lives within the catchment area of the study facility and must intend to continue to reside there for the duration of the study * For the RTI sub-study only: presence of respiratory symptoms compatible with RTI. Exclusion Criteria: * Weight less than 2.5kg * Main reason for consultation is an injury, trauma or acute poisoning * Enrolled in another clinical trial testing a new drug * Enrolled in a vaccine trial in the last 3 months. * Any other condition determined by the investigators that makes it unlikely that the participant would complete the study
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What it tests

  • IMCI-enhanced by suPAR levels (SoC + suPAR POC)
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Where

2 sites
CERMEL Centre de Recherches Médicales de Lambaréné
Lambaréné, Gabon
Mopeia Sede Health Centre
Mopeia, Mozambique
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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