NCT04760678

Febrile Illness in Kinshasa and Kimpese

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 1,046 (actual)
• Sponsor: Institute of Tropical Medicine, Belgium · Academic / Other
• Sex: All
• Age: 2 Months
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Febrile Illness

Interventions

Type	Name	Description
OTHER	Observational study	No intervention (observational study in human participants)

Timeline

• Start date: 2021-03-01
• Primary completion: 2023-09-18
• Completion: 2023-09-18
• First posted: 2021-02-18
• Last updated: 2025-03-06
• Results posted: 2025-03-06

Locations

2 sites across 1 country: Democratic Republic of the Congo