Actively Recruiting

Age: 2Months +
All Genders
Healthy Volunteers
NCT07345286

Clinical Aspects, Management and Surveillance of Febrile Illnesses in DRC

Led by Institute of Tropical Medicine, Belgium · Updated on 2026-01-15

500

Participants Needed

1

Research Sites

101 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Clinical Aspects, Management and Surveillance of Febrile Illnesses in DRC

Who Can Participate

Age: 2Months +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Ongoing fever measured at presentation or documented within 24 hours before, defined as axillary or tympanic temperature over 37.5°C, or oral or rectal temperature over 38°C
  • Ability to maintain contact with the study team on days 7, 14, and 21
  • Signed informed consent by the patient or legal representative, with child assent if aged 12 or older, when possible
Not Eligible

You will not qualify if you...

  • Child younger than 2 months old
  • Hospitalization longer than 48 hours within the past 14 days

AI-Screening

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Trial Site Locations

Total: 1 location

1

Centre Hospitalier Universitaire Renaissance

Kinshasa, Democratic Republic of the Congo

Actively Recruiting

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Research Team

E

Emmanuel Bottieau, PhD

CONTACT

S

Steven Declercq, MD

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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