NCT06422338 A Rapid Triage Test to Improve Risk-stratification of Febrile Children (EChiLiBRiST, Clinical Trial 1, Outpatients)
| NCT ID | NCT06422338 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Barcelona Institute for Global Health |
| Condition | Infectious Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 5,212 participants |
| Start Date | 2025-07-02 |
| Primary Completion | 2027-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 5,212 participants in total. It began in 2025-07-02 with a primary completion date of 2027-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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
Contact & Investigator
Quique Bassat, Prof
PRINCIPAL INVESTIGATOR
Barcelona Institute for Global Health
Frequently Asked Questions
Who can join the NCT06422338 clinical trial?
This trial is open to participants of all sexes, aged 2 Months or older, up to 60 Months, studying Infectious Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06422338 currently recruiting?
Yes, NCT06422338 is actively recruiting participants. Contact the research team at quique.bassat@isglobal.org for enrollment information.
Where is the NCT06422338 trial being conducted?
This trial is being conducted at Lambaréné, Gabon, Mopeia, Mozambique.
Who is sponsoring the NCT06422338 clinical trial?
NCT06422338 is sponsored by Barcelona Institute for Global Health. The principal investigator is Quique Bassat, Prof at Barcelona Institute for Global Health. The trial plans to enroll 5,212 participants.