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New rapid test could save lives of febrile children in africa

NCT ID NCT06422338

Diagnosis Sponsor: Barcelona Institute for Global Health Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jul 29, 2026 · Updated 2 times

Summary

This study tests whether a rapid triage test (suPAR) can help doctors make better decisions about admitting or discharging children with fever. Over 5,000 children aged 2 months to 5 years in sub-Saharan Africa will be randomly assigned to standard care or standard care plus the test. The goal is to see if the test reduces inappropriate discharges and improves health outcomes.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
suPAR point-of-care test
What this could lead to
If successful, this test could help doctors quickly identify which febrile children need hospital care, potentially saving lives and reducing unnecessary admissions.
What could go wrong
This is a large trial, but the test is new and may not improve outcomes over standard care. It is also limited to children in sub-Saharan Africa, so results may not apply elsewhere.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 5,212 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2025

Expected to finish

Aug 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

2 to 60 months

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

CHILD syndrome infectious disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Child, only Febrile illness Infectious disease

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    2 sites in 2 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • CERMEL Centre de Recherches Médicales de Lambaréné

    RECRUITING

    Lambaréné, Moyen-Ogooué Province, 242, Gabon

  • Mopeia Sede Health Centre

    RECRUITING

    Mopeia, Mozambique

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