Status:
RECRUITING
A Rapid Triage Test to Improve Risk-stratification of Febrile Children (EChiLiBRiST, Clinical Trial 1, Outpatients)
Lead Sponsor:
Barcelona Institute for Global Health
Conditions:
Infectious Disease
Febrile Illness
Eligibility:
All Genders
2-60 years
Phase:
NA
Brief 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 s...
Detailed Description
This is a multi-country, open label, two-arm, parallel-group, superiority, individually randomised clinical trial involving 2,606 febrile children per country (two countries, total n=5212). The trial ...
Eligibility Criteria
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
Key Trial Info
Start Date :
July 2 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2027
Estimated Enrollment :
5212 Patients enrolled
Trial Details
Trial ID
NCT06422338
Start Date
July 2 2025
End Date
March 1 2027
Last Update
February 17 2026
Active Locations (2)
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1
CERMEL Centre de Recherches Médicales de Lambaréné
Lambaréné, Moyen-Ogooué Province, Gabon, 242
2
Mopeia Sede Health Centre
Mopeia, Mozambique