An interventional study of IMCI-enhanced by suPAR levels (SoC + suPAR POC) in Infectious Disease, Febrile Illness and Child, Only, sponsored by Barcelona Institute for Global Health. Recruiting at 2 sites in 2 countries. Open to participants aged 2 Months to 60 Months. Per ClinicalTrials.gov, last updated 2026-07-28.
Sponsored by Barcelona Institute for Global Health · Not applicable, Interventional, and Other
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.
This is a multi-country, open label, two-arm, parallel-group, superiority, individually randomised clinical trial involving 2,606 febrile children per country (two countries, total n=5212). The trial will compare the performance of a point-of-care rapid triage test (POC-RTT) based on suPAR levels (i.e.suPARnostic®) (in combination with IMCI-based strategies, which are the SoC) to appropriately support admission/referral vs discharge decisions during the first clinical assessment of febrile children aged 2-\<60 months compared to the standard of care based on IMCI guidelines.
Febrile children meeting the study eligibility criteria will be randomly allocated (1:1) to one of the two triaging approaches (arms): 1) IMCI-based standard of care (SoC); or 2) IMCI-enhanced by suPAR levels (SoC + suPAR POC). Blood will be collected from all participants and only those randomised to the intervention arm (arm 2) will have suPAR levels determined at the POC using suPARnostic® device.
At baseline, all children will undergo two clinical assessments. Primary composite endpoint of "appropriateness of discharge" will be based on the first clinical assessment, which is more representative of real-world clinical practice. However, the ultimate decision on admission/referral vs discharge will be based on the second clinical assessment, which will ensure the safest possible clinical practice in the context of a clinical trial.
At baseline, during the first clinical assessment, all participants will be evaluated following the SoC based on IMCI guidelines, which will guide management decisions, including clinical diagnosis and treatment. This IMCI-guideline based evaluation during this first clinical assessment will be conducted by a health worker as per routine clinical practice in the outpatient departments of each study site.
The study intervention will be implemented during the first clinical assessment, and consequently, primary composite endpoint of "appropriateness of discharge" will be based on the decision of admission/referral vs discharge home during this first clinical assessment, which is more representative of routine clinical practice in each study site.
This second clinical assessment will guide the ultimate decision on admission/referral vs discharge in order to ensure the safest possible clinical practice in the context of a clinical trial.
Moreover, those participants with respiratory symptoms will be eligible for the respiratory tract infection (RTI) sub-study, where digital lung auscultations, a mid-turbinate nasal swab and a saliva sample will be collected.
Throughout the study, all participants will receive treatment as per the routine clinical practice and SoC for each diagnosis at each study site, administered by clinical staff routinely working in the participating facilities.
All participants will have follow-up evaluations by study clinicians on days 3 and 7 post-enrolment, or at any time in-between in case of clinical deterioration according to caregivers' evaluation. All participants will be also followed-up on day 28 for an interview to follow-up on serious adverse events (SAEs), as well as to collect information on secondary consultations and hospitalisation, or death. A follow-up extra visit at day 91 (month 3) can be conducted for an interview to ask for hospitalisation or death.
626 studies on the registry are indexed under Communicable Diseases; 128 are open to participants now.
This study's planned enrollment of 5,212 is above the median of 89 across 380 interventional studies indexed under Communicable Diseases.
Browse Communicable Diseases studies →Barcelona Institute for Global Health is the lead sponsor of 24 studies on the registry; 5 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
IMCI-guidelines (standard of care) + Point-Of-Care (POC) test based on suPAR quantification
Other: IMCI-enhanced by suPAR levels (SoC + suPAR POC)
IMCI-guidelines (standard of care)
IMCI-guidelines (standard of care) + Point-Of-Care (POC) based on suPAR quantification
Appropriateness of discharge
The primary outcome is the proportion of "appropriateness of discharge" according to the first clinical assessment of febrile children aged 2-\<60 months compared among the 2 study arms. Inappropriate discharge is defined as a composite of (fulfilling at least one of the following): 1. Presence at baseline of World Health Organization (WHO)-proposed danger signs in discharged children; OR 2. Presence of WHO-proposed danger signs on day 3 post-discharge; OR 3. Requirement for additional visit at the health facility or admission at day 7; OR 4. Death on day 7 post-discharge. The absence of any of these endpoints will be considered an appropriate discharge.
Time frame: Up to day 7
Secondary consultations or admissions
Proportion of secondary consultations or admissions on day 7 and day 28 among the two study arms.
Time frame: Up to day 28
Mortality
Proportion of mortality on day 7 and day 28 among the two study arms.
Time frame: Up to day 28
Referrals to higher level facilities
Proportion of referrals of mild infections to higher level facilities at day 7 and day 28 among the two study arms.
Time frame: Up to day 28
Severe disease
Proportion of participants diagnosed with severe disease as described in IMCI (i.e. very severe diseases, severe pneumonia, severe dehydration, severe persistent diarrhoea, very severe febrile diseases, severe complicated measles, complicated severe acute malnutrition, mastoiditis, and severe anaemia), at day 3 and day 7 among the two study arms.
Time frame: Up to day 7
Symptoms duration
Median time to symptoms resolution among the two study arms until day 28.
Time frame: Up to day 28
Hospital stay length
Median length of hospital stay among the two study arms until day 28
Time frame: Up to day 28
Serious adverse events
Proportion of serious adverse events (SAEs) at day 3, day 7, and day 28, among the two study arms.
Time frame: Up to day 28
Discharge in the major aetiological diagnosis
Proportion of "appropriateness of discharge decision" for the major aetiological diagnosis, including: malaria, respiratory and gastrointestinal infections, as well as in malnourished children, and HIV positive children, among the two study arms.
Time frame: Up to Day 28
Biomarkers reduction of outcomes
Proportion of "appropriateness of discharge decision" based on IMCI guidelines enhanced by suPAR levels quantified using B-Triage and other markers, compared to the clinical scores ED-PEWS, LqSOFA and LODS.
Time frame: Up to Day 28
Admissions in the routine care
Proportion of secondary consultations or admissions and mortality in the two study arms compared to available routine healthcare data.
Time frame: Up to Day 28
Biomarkers in admitted
Levels of suPAR and sTREM-1 and other circulating markers of endothelial function, angiogenesis, inflammation and intestinal barrier function at baseline and day 3 in plasma samples, and their association with admission.
Time frame: Up to Day 28
Secondary consultations or admission
Proportion of secondary consultations or admissions on day 91 (month 3) among the two study arms
Time frame: Up to day 91
Mortality
Proportion of mortality on day 91 (month 3) among the two study arms.
Time frame: Up to day 91
Sensitivity and specificity of POC
Sensitivity and Specificity of a POC test based on sTREM-1 to predict 28-day mortality and other severity outcomes in febrile children.
Time frame: Up to day 28
Endothelial activation markers in children with suspected Respiratory Tract Infections
Levels of immune and endothelial activation markers, including mucosal markers, in children with suspected Respiratory Tract Infections at baseline and day 3 in saliva samples, and their association with severity and antibiotic treatment.
Time frame: Up to day 28
Mucosal markers and species of bacteria and virus in children with Respiratory Tract Infections
Species of bacteria and virus present in the mucosa of children with Respiratory Tract Infections and their association with specific mucosal markers, susceptibility and prognosis of infection
Time frame: Up to day 7
Plan to share: Yes — This clinical trial, as part of the wider EChiLiBRiST project, is committed to European Union-funded Horizon 2021 aims to improve and maximize access to and reuse of research data generated by the Project. Biological samples and data will be shared using material and data transfer agreements with the collaborating institutions. The full protocol will be available on request to any interested professional and may be published in peer-reviewed journals or deposited in an online repository. A fully de-identified data set of the complete patient-level data will be available for sharing purposes as soon as the the analysis is completed and no later than five years after the publication of the trial.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report
Time frame: A fully de-identified data set of the complete patient-level data will be available for sharing purposes as soon as the data analysis is completed and no later than five years after the publication of the trial.
Access criteria: On request to any interested professional
No publications or documents are linked to this record.
Started Jul 2025 (actual). Primary completion is estimated for Jun 2027, 23 months after the start.
Of 128 non-industry interventional studies with no phase under Communicable Diseases, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 36. This study's planned 23 months is close to that.
Counting every sponsor, half of 144 studies reached it within 21 months; a quarter within 6 and three quarters within 36.
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Barcelona Institute for Global Health