Clinical Aspects, Management and Surveillance of Febrile Illnesses in DRC

NCT07345286 | Recruiting

• 1 other identifier: 1822/24
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

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.

Conditions

Febrile Illness Acute; Biomarkers; Surveillance

Keywords

febrile illness; CRP; biomarkers; surveillance; clinical characteristics; Subsaharan Africa; malaria

Outcome Measures

Primary Outcomes (11)

• 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

  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)

  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

  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

  at enrollment

• Describe clinical presentation of febrile illnesses in the DRC.

  endpoints: \- Frequency of specific symptoms

  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

  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

  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

  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

  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

  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

  from enrollment to the end of the 3 week follow-up period

Secondary Outcomes (3)

• 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.

  at inclusion

• Evaluate the field accuracy of clinical case definitions currently used for national surveillance of the epidemic-prone subgroup.

  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.

  from enrollment to the end of the 3 week follow-up period

Other Outcomes (4)

• Describe the frequency and etiology of community-acquired bacteremias detected in patients with febrile illness

  at inclusion

• Describe the antibiotic resistance profiles of community-acquired bacteremias detected in patients with febrile illness

  at inclusion

• Describe the frequency of arboviral diseases detected by a specific PCR panel (initially Dengue, Chikungunya, Zika, Yellow Fever)

  from enrollment to the end of the 3 week follow-up period

Study Arms (1)

patients with febrile illness

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

Eligibility Criteria

• Age: 2 Months+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

patients with febrile illness presenting at the study site

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.

Sponsors & Collaborators

• Institute of Tropical Medicine, Belgium: lead

Study Sites (1)

Centre Hospitalier Universitaire Renaissance

Kinshasa, Democratic Republic of the Congo

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Plasma full blood treated with DNA/RNA shield

MeSH Terms

Conditions

Malaria

Condition Hierarchy (Ancestors)

Protozoan Infections; Parasitic Diseases; Infections; Mosquito-Borne Diseases; Vector Borne Diseases

Study Officials

• Emmanuel Bottieau, PhD

  ITM

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Emmanuel Bottieau, PhD

CONTACT

+3232476450; ebottieau@itg.be

Steven Declercq, MD

CONTACT

+32479282217; sdeclercq@itg.be

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 9, 2025
• First Posted: January 15, 2026
• Study Start: January 20, 2025
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027
• Last Updated: January 15, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• 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.

Locations

DE (1)