CompletedNot Applicable

Febrile Illness in Kinshasa and Kimpese

Democratic Republic of the Congo1,046 participantsStarted 2021-03-01

Plain-language 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.

Who can participate

Age range

2 Months

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Ongoing and objectified fever at presentation, or documented at home or other health center within 24 hours prior to presentation, defined by:
. 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)

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Proportion of Survival With Symptom Resolution

Timeframe: Day 21

CRP Values

Timeframe: Day 0

White Blood Cell Count

Timeframe: day 0

Trial details

NCT IDNCT04760678

SponsorInstitute of Tropical Medicine, Belgium

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2023-09-18

Results submitted2024-10-25

View on ClinicalTrials.gov More Febrile Illness trials