Rapid suPAR blood test to help triage febrile young children

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.