CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 1,046 enrolled
Drug / intervention
Observational studyother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

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Search/NCT04760678
NCT04760678N/ACompleted

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

Institute of Tropical Medicine, Belgium·observational·Posted Feb 18, 2021·Updated Mar 6, 2025

In Brief

An observational study evaluating Observational study for Febrile Illness. Completed, enrolled 1,046 participants across 2 sites.

Detailed 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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsFebrile Illness
CountriesDemocratic Republic of the Congo

Timeline

N/ACompletedFinished
202120222023202420252026
First PostedFeb 18, 2021
Enrollment StartMar 1, 2021
Primary CompletionSep 18, 2023
TodayJul 2, 2026
Enrollment to primary: 2.5 yearsPosted 5.4 years ago

Interventions

Observational studyother

No intervention (observational study in human participants)