Rapid suPAR blood test to help triage febrile young children
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
This study will test whether adding a quick suPAR point-of-care blood test to standard IMCI triage helps health workers better spot children aged 2–59 months with fever who need admission or referral.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 5212 (estimated) |
| Ages | 2 Months to 60 Months |
| Sex | All |
| Sponsor | Barcelona Institute for Global Health Academic / other |
| Locations | 2 sites (Lambaréné, Moyen-Ogooué Province and 1 other locations) |
| Trial ID | NCT06422338 on ClinicalTrials.gov |
What this trial studies
This is an open-label, individually randomized, two-arm superiority trial conducted at outpatient sites in two sub-Saharan African locations with about 5,212 children total. Children meeting eligibility are randomized 1:1 to either standard IMCI-based triage or IMCI plus a point-of-care suPAR test (suPARnostic®); blood is drawn from all participants but suPAR results are only used for the intervention arm. The primary composite endpoint is the appropriateness of discharge determined from the first clinical assessment, while a second assessment informs the final clinical decision for safety. The trial aims to see if adding a rapid biomarker improves early admission/referral decisions and overall outcomes for febrile children in these settings.
Who should consider this trial
Good fit: Ideal candidates are children aged 2 to 59 months presenting to the participating outpatient clinics with fever (≤7 days), hypothermia, or suspected severe infection whose caregiver provides informed consent and who live in the study catchment area.
Not a fit: Children whose main problem is injury/trauma or poisoning, those under 2.5 kg, those currently in certain drug trials or recently in vaccine trials, or those unlikely to complete follow-up are unlikely to gain benefit from participation.
Why it matters
Potential benefit: If successful, this approach could help clinicians more quickly identify children at higher risk of severe infection and reduce missed or delayed admissions, improving child outcomes.
How similar studies have performed: Prior observational studies have linked higher suPAR levels with severe infection and worse outcomes, but randomized point-of-care suPAR-guided triage in febrile children is a relatively novel approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Lambaréné, Moyen-Ogooué Province and 1 other locations
- CERMEL Centre de Recherches Médicales de Lambaréné — Lambaréné, Moyen-Ogooué Province, Gabon (Recruiting)
- Mopeia Sede Health Centre — Mopeia, Mozambique (Recruiting)
Study contacts
- Principal investigator: Quique Bassat, Prof — Barcelona Institute for Global Health
- Study coordinator: Quique Bassat, Prof
- Email: quique.bassat@isglobal.org
- Phone: 93 227 92 12
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.