NCT07345286 Clinical Aspects, Management and Surveillance of Febrile Illnesses in DRC
| NCT ID | NCT07345286 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Institute of Tropical Medicine, Belgium |
| Condition | Febrile Illness Acute |
| Study Type | OBSERVATIONAL |
| Enrollment | 500 participants |
| Start Date | 2025-01-20 |
| Primary Completion | 2027-01-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 500 participants in total. It began in 2025-01-20 with a primary completion date of 2027-01-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The epidemiology and outcome of febrile illnesses in the Democratic Republic of Congo (DRC) is poorly documented. The FIKI² study, a prospective observational study of community-acquired febrile illnesses coordinated by ITM and INRB and conducted at 2 clinical sites from 2021 to 2023, has deepened the knowledge of clinical presentation, etiology, outcome and profile of inflammatory/infectious biomarkers (white blood cells and C-reactive protein, or CRP). The management of febrile illnesses remains fraught with clinical challenges. Overuse of antibiotics in primary care remains a reality in the field, and has been observed in several studies, including FIKI². A number of initiatives are underway to address this problem, such as the use of biomarkers, the development of treatment guidelines and electronic decision support systems. The FIKI² study highlighted the potential role of CRP in rationalizing antibiotic use. In parallel, the 'AWARE antibiotic book' was published at the end of 2022 by the WHO, providing recommendations on the choice (or otherwise) of antibiotic therapy for over 30 common clinical infections, in both primary care and hospital settings. Based on the results of the FIKI² study, the main aim of the FI-CARE study is to investigate the impact of these new tools (CRP biomarker, AWARE antibiotic book, and electronic decision support systems) on first-line antibiotic use. Secondly, the study will consolidate previous results from FIKI² sites in terms of monitoring the etiologies of community-acquired febrile illnesses (particularly arboviruses); and reinforce this monitoring at new sites (depending on opportunities). This complementary study will also pursue FIKI²'s strategic objectives of strengthening clinical research capacity and consolidating biobanks in the DRC. FI-CARE is a prospective, observational, multicenter cohort study of adults and children presenting to the emergency department or outpatient clinic with community-acquired febrile illness. A laboratory component with sample storage in a biobank is added in a modular fashion according to laboratory and research capacities, epidemiological interest and available funds.
Eligibility Criteria
Inclusion Criteria: * Ongoing fever objectified at presentation, or documented at home or other health center within 24 hours prior to presentation, defined as: axillary or tympanic temperature \> 37.5°C, or oral or rectal temperature \> 38°C. * Opportunity for contact between patient (or designated relative) and study team on days 7, 14 and 21. * Informed consent to participate signed by the patient (adult) or a legally acceptable representative (child or patients whose condition does not allow them to sign informed consent), with the assent of children aged 12 and over, wherever possible. Exclusion Criteria: * Child less than two months old. * Hospitalization of \> 48h in the last 14 days.
Contact & Investigator
Emmanuel Bottieau, PhD
PRINCIPAL INVESTIGATOR
ITM
Frequently Asked Questions
Who can join the NCT07345286 clinical trial?
This trial is open to participants of all sexes, aged 2 Months or older, studying Febrile Illness Acute. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07345286 currently recruiting?
Yes, NCT07345286 is actively recruiting participants. Contact the research team at ebottieau@itg.be for enrollment information.
Where is the NCT07345286 trial being conducted?
This trial is being conducted at Kinshasa, Democratic Republic of the Congo.
Who is sponsoring the NCT07345286 clinical trial?
NCT07345286 is sponsored by Institute of Tropical Medicine, Belgium. The principal investigator is Emmanuel Bottieau, PhD at ITM. The trial plans to enroll 500 participants.