An observational study in Febrile Illness Acute, Biomarkers and Surveillance, sponsored by Institute of Tropical Medicine, Belgium. Recruiting at 1 site in Democratic Republic of the Congo. Open to participants aged 2 Months and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-01-15.
Sponsored by Institute of Tropical Medicine, Belgium · Observational
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.
The management of febrile illnesses in low resource settings remains fraught with clinical challenges. Overuse of antibiotics in primary care remains a reality in the field, and has been observed in several studies. 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 '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.
As in most sub-Saharan African countries, very little data is available in the Democratic Republic of Congo (DRC) on the epidemiology, clinical presentation, causes and outcome of febrile illnesses, and research capacity is generally very weak.
FIKI² was a bi-centric observational study of febrile illnesses conducted between March 29, 2021 and October 9, 2023 at two newly established research sites in the DRC: (i) the pediatric emergency department of the Hôpital Général de Référence de Kinshasa (HGRK) - now the Centre Hospitalier Universitaire Renaissance (CHUR) - , and (ii) the emergency and outpatient department of the Hôpital Général de Référence (HGR) of the Institut Médical Evangélique (IME) in Kimpese.
The study prospectively recruited patients presenting with fever and collected data on clinical and laboratory characteristics at the time of consultation and during a three-week follow-up period. The study included the routine performance of a thick smear and/or RDT for malaria, in line with routine care, as well as the performance of an RDT for dengue and the measurement of CRP, hemoglobin, white blood cell count and differentiation as study laboratory procedures.
The study was also integrated for part of its duration into a blood culture surveillance project (protocol approved in Belgium and DRC). Blood samples were also collected for long-term storage and secondary research during the second phase of the study for consenting patients.
The conduct of the study was integrated with research and clinical capacity building, focusing on clinical assessment and CRP evaluation in the management process, in order to reduce antibiotic overuse.
The study provided important insights into the clinical presentation of febrile illnesses, and confirmed the significant impact of malaria on CRP levels, as well as its discriminating value in cases of undifferentiated fever and non-malarial respiratory tract infection. It highlighted a relatively high frequency of fever-associated bacteremia in ambulatory patients (of unclear clinical significance). The study confirmed high rates of inappropriate antibiotic prescribing. While FIKI² was not an interventional study, it was observed that the implementation of CRP was progressively associated with a marked reduction in antibiotic use (especially in cases of undifferentiated fever and non-malarial respiratory tract infection with normal CRP levels), once this test was integrated into the reasoning of the investigating clinicians.
FI-CARE study is a new study that extends the FIKI² study in terms of consolidating epidemiological and etiological research, but has as new objectives to measure the impact of CRP and the AWaRe guide on clinical management (reduction in antibiotic prescribing) AND to integrate effective surveillance of febrile illnesses with epidemic potential into primary care. Similar data collection tools as the FIKI² study will allow comparative analyses between the 2 studies.
In the first instance, the study takes place at the known site of the pediatric emergency department of the 'Centre Hospitalier Universitaire Renaissance de Kinshasa' (CHUR, formerly HGRK). Other sites may be added in the future, depending on epidemiological interest, research capacity and available funding (compatible with the principle of FA5 funds as seed money that can be used to attract further funding). The study is conceptualized as a modular one, with different levels of research depending on the research capacity and level of funding available at the sites involved:
Etiological investigation of specific febrile illnesses
Study procedures are as follows:
1,184 studies on the registry are indexed under Malaria; 79 are open to participants now.
This study's planned enrollment of 500 is below the median of 582 across 204 observational studies indexed under Malaria.
Browse Malaria studies →Institute of Tropical Medicine, Belgium is the lead sponsor of 104 studies on the registry; 21 are open to participants now.
Counted across the registry records on this site, refreshed daily.
patients with febrile illness presenting at the study site
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients with febrile illness matching inclusion/exclusion criteria presenting at emergency department or outpatient clinic. At this moment one site has been selected. Other sites might be added in the future given rise to other cohorts of febrile patients
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 enrollment
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 enrollment
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 enrollment
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 enrollment
Describe clinical presentation of febrile illnesses in the DRC.
endpoints: \- Frequency of specific symptoms
Time frame: from enrollment to the end of the 3 week follow-up period
Describe laboratory presentation of febrile illnesses in the DRC.
endpoints: \- Frequency of laboratory deviations
Time frame: from enrollment to the end of the 3 week follow-up period
Describe severity of febrile illnesses in the DRC.
endpoints: \- frequency of presence of severity criteria
Time frame: from enrollment to the end of the 3 week follow-up period
Describe etiology of febrile illnesses in the DRC.
endpoints: \- Frequency of specific and syndromic diagnoses
Time frame: from enrollment to the end of the 3 week follow-up period
Evaluate the frequency of hospital admissions for febrile illnesses in the DRC.
endpoints: \- Proportion of patients with a primary or secondary hospital admission
Time frame: from enrollment to the end of the 3 week follow-up period
Evaluate the frequency of secondary visits for febrile illnesses in the DRC.
endpoints: \- Proportion of patients with secondary visits
Time frame: from enrollment to the end of the 3 week follow-up period
Describe outcome of febrile illnesses in the DRC.
endpoints: \- Proportion of participants resolved, unresolved and dead by day 21
Time frame: from enrollment to the end of the 3 week follow-up period
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 inclusion
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 period
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 period
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 inclusion
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 inclusion
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 period
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 period
Plan to share: Yes — Anonymized study data will be supplemented by metadata and documentation, such as the study protocol, annotated CRFs and other information such as codes, which together constitute a dataset, but will not include any direct identifiers.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report
Time frame: Study data relating to participants will be available for sharing within a reasonable time after the study and in accordance with ITM's research data sharing principles for a duration of 2O years.
Access criteria: Researchers will be able to request access to anonymized data for well-defined research or secondary analysis via a controlled access procedure.
Data sharing details ↗ · www.itg.be
No publications or documents are linked to this record.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Institute of Tropical Medicine, Belgium →