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
1 other identifier
interventional
5,212
2 countries
2
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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jul 2025
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 10, 2024
CompletedFirst Posted
Study publicly available on registry
May 21, 2024
CompletedStudy Start
First participant enrolled
July 2, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 1, 2027
February 17, 2026
February 1, 2026
1.4 years
May 10, 2024
February 12, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Appropriateness of discharge
The primary outcome is the proportion of "appropriateness of discharge" according to the first clinical assessment of febrile children aged 2-\<60 months compared among the 2 study arms. Inappropriate discharge is defined as a composite of (fulfilling at least one of the following): 1. Presence at baseline of World Health Organization (WHO)-proposed danger signs in discharged children; OR 2. Presence of WHO-proposed danger signs on day 3 post-discharge; OR 3. Requirement for additional visit at the health facility or admission at day 7; OR 4. Death on day 7 post-discharge. The absence of any of these endpoints will be considered an appropriate discharge.
Up to day 7
Secondary Outcomes (11)
Secondary consultations or admissions
Up to day 28
Mortality
Up to day 28
Referrals to higher level facilities
Up to day 28
Severe disease
Up to day 7
Symptoms duration
Up to day 28
- +6 more secondary outcomes
Other Outcomes (5)
Secondary consultations or admission
Up to day 91
Mortality
Up to day 91
Sensitivity and specificity of POC
Up to day 28
- +2 more other outcomes
Study Arms (2)
IMCI-enhanced by suPAR levels (SoC + suPAR POC).
EXPERIMENTALIMCI-guidelines (standard of care) + Point-Of-Care (POC) test based on suPAR quantification
IMCI alone
NO INTERVENTIONIMCI-guidelines (standard of care)
Interventions
IMCI-guidelines (standard of care) + Point-Of-Care (POC) based on suPAR quantification
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
CERMEL Centre de Recherches Médicales de Lambaréné
Lambaréné, Moyen-Ogooué Province, 242, Gabon
Mopeia Sede Health Centre
Mopeia, Mozambique
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Quique Bassat, Prof
Barcelona Institute for Global Health
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 10, 2024
First Posted
May 21, 2024
Study Start
July 2, 2025
Primary Completion (Estimated)
December 1, 2026
Study Completion (Estimated)
March 1, 2027
Last Updated
February 17, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR
- Time Frame
- A fully de-identified data set of the complete patient-level data will be available for sharing purposes as soon as the data analysis is completed and no later than five years after the publication of the trial.
- Access Criteria
- On request to any interested professional
This clinical trial, as part of the wider EChiLiBRiST project, is committed to European Union-funded Horizon 2021 aims to improve and maximize access to and reuse of research data generated by the Project. Biological samples and data will be shared using material and data transfer agreements with the collaborating institutions. The full protocol will be available on request to any interested professional and may be published in peer-reviewed journals or deposited in an online repository. A fully de-identified data set of the complete patient-level data will be available for sharing purposes as soon as the the analysis is completed and no later than five years after the publication of the trial.