Febrile Illness in Kinshasa and Kimpese

Study Overview
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Brief Summary
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This is a bi-centric prospective observational cohort study of adults and children presenting to the emergency room or outpatient department with community febrile illness (with or without signs of focalization) in 2 clinical sites (hospitals) in the DRC. The study will describe the epidemiology, clinical aspects, severity, management and outcome of febrile illnesses using data collected during routine diagnostic and therapeutic procedures. Each patient will be followed for 21 days. The follow-up will include Daily visits for hospitalized patients, Telephone calls (or study center visit or home visit) on days 7, 14 and 21 for outpatients and discharged patients. The study has been amended (EC UZA approval in June 2021) to perform a set of laboratory analyses in the partners institutions and at the ITM. We aim as a new primary objective at describing the profile of different biomarkers (C-reactive protein and white blood cell count with differentiation) in participants enrolled with febrile illness, and as secondary objectives to correlate them with outcome (assessed at day 21) and with several etiological diagnoses, especially malaria (as assessed by rapid diagnostic test and blood smear). The purpose is to investigate the potential diagnostic and prognostic value of these biomarkers which are increasingly available at the point-of-care.

Official Title
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Clinical Aspects, Severity, Management and Outcome of Febrile Illnesses in the Democratic Republic Congo (DRC).

Conditions
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Febrile Illness

Intervention / Treatment
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* Other: Observational study


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Ongoing and objectified fever at presentation, or documented at home or other health center within 24 hours prior to presentation, defined by: Axillary or tympanic temperature > 37.5°C OR Oral or rectal temperature > 38°C Possibility of contact between the patient (or designated relative) and the study team on days 7, 14 and 21 Informed consent signed by the patient (adults) or a legally acceptable representative (children or patients whose condition does not allow them to sign informed consent), with the consent of children as young as 12 years of age, whenever possible. Exclusion Criteria: Children less than two months old Hospitalization > 48 h in the last 14 days (to exclude nosocomial fevers)

Ages Eligible for Study
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Minimum Age: 2 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Observational study|No intervention (observational study in human participants)|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of survival with symptom resolution | Proportion of survival with symptom resolution assessed at day 21, of febrile illnesses | Day 21 | 
| CRP values and white blood cell count | CRP values and white blood cell count with differentiation at day 0 (inclusion) | Day 0 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical status according to a 3-category ordinal scale (resolution, non-resolution, death) | Clinical status according to a 3-category ordinal scale (resolution, non-resolution, death) assessed at days 7, 14 and 21. | Day 7, 14 and 21 | 
| Inclusion diagnostic assumptions and final diagnoses | Inclusion diagnostic assumptions and final diagnoses. | Day 0 and Day 21 | 
| Severity of illness | Severity of illness on days 0, 7, 14 and 21 | Day 0, 7, 14 and 21 | 
| Initial and secondary hospitalization | Initial and secondary hospitalization (assessed at Day 21) | Day 21 | 
| Length of hospital stay (initial and/or secondary hospitalization) | Length of hospital stay (initial and/or secondary hospitalization) assessed at day 21 | Day 21 | 
| Number of secondary visits | Number of secondary visits (assessed at Day 21). | Day 21 | 
| Number and types of laboratory and radiological examinations prescribed / actually performed | Number and types of laboratory and radiological examinations prescribed / actually performed | Day 21 | 
| Number and types of medications and supportive care prescribed/actually administered. | Number and types of medications and supportive care prescribed/actually administered. | Day 21 | 
| Malaria detection | Malaria detection by rapid test (HRP II antigen, pLDH antigen) and thick drop (type and parasitaemia) | Day 21 | 
| Patient outcomes | Association of CRP values and white blood cell counts with patient outcomes | Day 21 | 
| Specific etiologies | Association of CRP and WBC values with specific etiologies (malaria, bacteremia, dengue,...) | Day 21 |