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

Infectious Disease

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

Inclusion Criteria5

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 Criteria5

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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