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.
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
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.
Parallel
IMCI-enhanced by suPAR levels (SoC + suPAR POC)
Other interventionIMCI-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.
Secondary consultations or admissions
Proportion of secondary consultations or admissions on day 7 and day 28 among the two study arms.
Mortality
Proportion of mortality on day 7 and day 28 among the two study arms.
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.
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.
Secondary consultations or admission
Proportion of secondary consultations or admissions on day 91 (month 3) among the two study arms
Mortality
Proportion of mortality on day 91 (month 3) among the two study arms.
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.
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.
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