Actively Recruiting
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
Led by Barcelona Institute for Global Health · Updated on 2026-02-17
5212
Participants Needed
2
Research Sites
12 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating whether adding a rapid biomarker test to current clinical guidelines can better identify young children with fever who are at risk of serious infections in sub-Saharan Africa. This study compares standard care based on integrated management of childhood illness (IMCI) guidelines alone to an approach enhanced by measuring suPAR levels, a biomarker, during the first clinical assessment. The goal is to see if this combined strategy improves decisions about hospital admission or discharge and leads to better health outcomes for children aged 2 to under 60 months. The trial is a multi-country, open-label, randomized study with two groups: one receiving the standard IMCI-based care and the other receiving IMCI care plus a point-of-care suPAR test. Blood samples will be taken from all children, but only the intervention group will have their suPAR levels measured immediately. Clinicians will use these results along with IMCI guidelines to decide whether to admit or discharge each child during the first clinical visit. A second, more detailed clinical assessment will also be performed on all participants to confirm or adjust decisions and ensure safety. Children will be followed up on days 3 and 7 after enrollment with additional visits if clinical worsening occurs. A day 28 follow-up will collect information on serious events, hospitalizations, or deaths, with an optional extra interview at three months. Participants with respiratory symptoms may join a substudy involving lung exams and sample collections. The study team will measure outcomes like the appropriateness of discharge decisions, hospital admissions, severity of illness, and mortality to evaluate the new triage approach's effectiveness and safety over these timeframes.
CONDITIONS
Brief Title
A Rapid Triage Test to Improve Risk-stratification of Febrile Children (EChiLiBRiST, Clinical Trial 1, Outpatients)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 2 months and under 60 months
- Written informed consent from the child's parent or caregiver
- History of fever for 7 days or less, or hypothermia (axillary temperature below 35.5�C), or suspected severe infection
- Lives within the study facility's catchment area and intends to remain there during the study
- For respiratory sub-study only: presence of respiratory symptoms compatible with respiratory tract infection
You will not qualify if you...
- Weight less than 2.5 kg
- Main reason for consultation is injury, trauma, or acute poisoning
- Currently enrolled in another clinical trial testing a new drug
- Enrolled in a vaccine trial within the last 3 months
- Any condition deemed by investigators to make study completion unlikely
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - Up to 1 day
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Same day as screening
Participants undergo the first clinical assessment where febrile children are evaluated using either standard IMCI guidelines alone or IMCI guidelines enhanced by a rapid suPAR test to guide admission or discharge decisions. A second clinical assessment by an independent physician is conducted to confirm or adjust the initial management decision to ensure safety.
2 clinical assessments in 1 day (in-person)
Duration - 28 to 91 days
Participants have follow-up evaluations on days 3 and 7 post-enrolment to monitor clinical status, with additional visits if clinical deterioration occurs. A day 28 visit includes an interview to assess serious adverse events, hospitalizations, and mortality. An optional visit at day 91 collects longer-term safety information.
Visits on days 3, 7, 28, and optionally day 91 (in-person or phone)
Trial Site Locations
Total: 2 locations
1
CERMEL Centre de Recherches Médicales de Lambaréné
Lambaréné, Moyen-Ogooué Province, Gabon, 242
Actively Recruiting
2
Mopeia Sede Health Centre
Mopeia, Mozambique
Actively Recruiting
Research Team
Q
Quique Bassat, Prof
B
Barbara Baro, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
2
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