Clinical Aspects, Management and Surveillance of Febrile Illnesses in DRC
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age2+
SponsorInstitute of Tropical Medicine, Belgium
About this trial
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
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
Child less than two months old.
Hospitalization of > 48h in the last 14 days.
Trial population
patients with febrile illness presenting at the study site
Trial design
Design model
Case-only
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
500 Participants
are grouped into 1 trial groupGroup A: patients with febrile illness
Trial outcomes
Primary outcomes
1
Describe and compare the use of antibiotics for patients with community-acquired febrile illness with different types of support
Describe and compare the use of antibiotics for patients with community-acquired febrile illness with different types of support that can be used throughout the study to guide patient management (e.g. algorithm combining presenting syndrome with CRP results; etiological approach based on the WHO clinical guide (AWARE antibiotic book) or other; or any new electronic decision-making support). Endpoints: Frequency of antibiotics and class of antibiotics used with different types of support
Time frame
at enrollment2
Describe the appropriateness of antibiotics for patients with community-acquired febrile illness with different types of support
Describe the appropriateness of antibiotics for patients with community-acquired febrile illness with different types of support that can be used throughout the study to guide patient management (e.g. algorithm combining presenting syndrome with CRP results; etiological approach based on the WHO clinical guide (AWARE antibiotic book) or other; or any new electronic decision-making support). Endpoints: \- Appropriateness of antibiotic use (according to local clinical guidelines if available or WHO)
Time frame
at enrollment3
Describe and compare adherence to different types of support used
Describe and compare adherence to the tools used to guide patient management (syndromic algorithm; AWARE antibiotic book or other etiological guide; or an electronic decision support). Endpoints: \- frequency of adherence to recommendations
Time frame
at enrollment4
Describe reasons for non-adherence to different types of support used
Describe reasons for non-adherence to the tools used to guide patient management (syndromic algorithm; AWARE antibiotic book or other etiological guide; or an electronic decision support). Endpoints: \- frequency of reasons for non-adherence
Time frame
at enrollmentSecondary outcomes
1
Describe the biomarker profile (CRP, white blood cell count with differentiation) at inclusion of patients with febrile illnesses, and its correlation with specific and syndromic diagnoses and outcome.
endpoint: White blood cell and CRP levels at baseline overall and for different patient categories (specific diagnosis and outcomes)
Time frame
at inclusion2
Evaluate the field accuracy of clinical case definitions currently used for national surveillance of the epidemic-prone subgroup.
Endpoint: proportion of cases meeting one of the case definitions for diseases under surveillance correlated with final diagnosis
Time frame
from enrollment to the end of the 3 week follow-up period3
Evaluate the timeliness of reporting for diseases under national surveillance, of the epidemic-prone subgroup.
Endpoint: proportion of diseases under national surveillance, of the epidemic-prone subgroup reported to health authorities in time.
Time frame
from enrollment to the end of the 3 week follow-up periodOther outcomes
1
Describe the frequency and etiology of community-acquired bacteremias detected in patients with febrile illness
Endpoint: frequency of bacteremia and identified germs.
Time frame
at inclusion2
Describe the antibiotic resistance profiles of community-acquired bacteremias detected in patients with febrile illness
Endpoint: frequency of antibiotic resistance profiles of identified germs causing bacteremia.
Time frame
at inclusion3
Describe the frequency of arboviral diseases detected by a specific PCR panel (initially Dengue, Chikungunya, Zika, Yellow Fever)
Endpoint: \- frequency of confirmed arbovirus pathogens
Time frame
from enrollment to the end of the 3 week follow-up period4
Describe clinical and biological presentation of arboviral diseases detected by a specific PCR panel (initially Dengue, Chikungunya, Zika, Yellow Fever)
Endpoint: \- frequency of specific clinical and laboratory predictors.
Time frame
from enrollment to the end of the 3 week follow-up periodSponsors and contacts
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Source ClinicalTrials.gov