Clinical Aspects, Management and Surveillance of Febrile Illnesses in DRC
Recruiting now
Conditions studied: Febrile Illness Acute, Biomarkers, Surveillance
In brief
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.
Key facts
- Study ID
- NCT07345286
- Run by
- Institute of Tropical Medicine, Belgium
- People needed
- 500
- Starts
- 2025-01-20
- Expected to finish
- 2027-01-01
- Last updated by the study team
- 2026-01-15
Who can join
Age: 0 and older. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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.
You may not qualify if…
- Child less than two months old.
- Hospitalization of > 48h in the last 14 days.
Where it is running
- Centre Hospitalier Universitaire Renaissance — Kinshasa, Democratic Republic of the Congo (enrolling)
Full record on ClinicalTrials.gov
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