Febrile Illness in Kinshasa and Kimpese (FIKI²)

  • STATUS
    Recruiting
  • End date
    May 31, 2023
  • participants needed
    1500
  • sponsor
    Institute of Tropical Medicine, Belgium
Updated on 23 April 2022

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.

Details
Condition Febrile Illness
Treatment Observational study
Clinical Study IdentifierNCT04760678
SponsorInstitute of Tropical Medicine, Belgium
Last Modified on23 April 2022

Eligibility

Yes No Not Sure

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
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
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

Exclusion Criteria

Children less than two months old
Hospitalization > 48 h in the last 14 days (to exclude nosocomial fevers)
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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