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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age2-60
SponsorBarcelona Institute for Global Health

About this trial

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 criteria

Qualifiers

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

Disqualifiers

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.

Trial design

Treatments tested in this trial

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

Treatment groups

5,212 Participants
are divided into 2 treatment groups