Febrile Illness in Kinshasa and Kimpese

Febrile Illness Clinical Trial

— FIKI²  

Official title:

Clinical Aspects, Severity, Management and Outcome of Febrile Illnesses in the Democratic Republic Congo (DRC).

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04760678
• Other study ID #: FIKI²
• Status: Active, not recruiting
• Start date: March 1, 2021
• Est. completion date: May 31, 2024

Study information

• Verified date: March 2024
• Source: Institute of Tropical Medicine, Belgium
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This is a bi-centric prospective observational cohort study of adults and children presenting to the emergency room or outpatient department with community febrile illness (with or without signs of focalization) in 2 clinical sites (hospitals) in the DRC. The study will describe the epidemiology, clinical aspects, severity, management and outcome of febrile illnesses using data collected during routine diagnostic and therapeutic procedures.

Each patient will be followed for 21 days. The follow-up will include

• Daily visits for hospitalized patients,

• Telephone calls (or study center visit or home visit) on days 7, 14 and 21 for outpatients and discharged patients.

The study has been amended (EC UZA approval in June 2021) to perform a set of laboratory analyses in the partners institutions and at the ITM. We aim as a new primary objective at describing the profile of different biomarkers (C-reactive protein and white blood cell count with differentiation) in participants enrolled with febrile illness, and as secondary objectives to correlate them with outcome (assessed at day 21) and with several etiological diagnoses, especially malaria (as assessed by rapid diagnostic test and blood smear). The purpose is to investigate the potential diagnostic and prognostic value of these biomarkers which are increasingly available at the point-of-care.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1045
• Est. completion date: May 31, 2024
• Est. primary completion date: September 18, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Months and older

Eligibility

Inclusion Criteria:

1. Ongoing and objectified fever at presentation, or documented at home or other health center within 24 hours prior to presentation, defined by:

• Axillary or tympanic temperature > 37.5°C OR

• Oral or rectal temperature > 38°C

2. Possibility of contact between the patient (or designated relative) and the study team on days 7, 14 and 21

3. Informed consent signed by the patient (adults) or a legally acceptable representative (children or patients whose condition does not allow them to sign informed consent), with the consent of children as young as 12 years of age, whenever possible.

Exclusion Criteria:

1. Children less than two months old

2. Hospitalization > 48 h in the last 14 days (to exclude nosocomial fevers)

Related Conditions & MeSH terms

• Febrile Illness
• Fever
• Hyperthermia

Intervention

Other:
• Observational study
No intervention (observational study in human participants)

Locations

Country	Name	City	State
Congo, The Democratic Republic of the	IME Kimpese	Kimpese	Kongo Central
Congo, The Democratic Republic of the	Hôpital General de Kinshasa	Kinshasa

Sponsors (2)

Lead Sponsor	Collaborator
Institute of Tropical Medicine, Belgium	Institut National de Recherche Biomédicale. Kinshasa, République Démocratique du Congo

Country where clinical trial is conducted

Congo, The Democratic Republic of the, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of survival with symptom resolution	Proportion of survival with symptom resolution assessed at day 21, of febrile illnesses	Day 21
Primary	CRP values and white blood cell count	CRP values and white blood cell count with differentiation at day 0 (inclusion)	Day 0
Secondary	Clinical status according to a 3-category ordinal scale (resolution, non-resolution, death)	Clinical status according to a 3-category ordinal scale (resolution, non-resolution, death) assessed at days 7, 14 and 21.	Day 7, 14 and 21
Secondary	Inclusion diagnostic assumptions and final diagnoses	Inclusion diagnostic assumptions and final diagnoses.	Day 0 and Day 21
Secondary	Severity of illness	Severity of illness on days 0, 7, 14 and 21	Day 0, 7, 14 and 21
Secondary	Initial and secondary hospitalization	Initial and secondary hospitalization (assessed at Day 21)	Day 21
Secondary	Length of hospital stay (initial and/or secondary hospitalization)	Length of hospital stay (initial and/or secondary hospitalization) assessed at day 21	Day 21
Secondary	Number of secondary visits	Number of secondary visits (assessed at Day 21).	Day 21
Secondary	Number and types of laboratory and radiological examinations prescribed / actually performed	Number and types of laboratory and radiological examinations prescribed / actually performed	Day 21
Secondary	Number and types of medications and supportive care prescribed/actually administered.	Number and types of medications and supportive care prescribed/actually administered.	Day 21
Secondary	Malaria detection	Malaria detection by rapid test (HRP II antigen, pLDH antigen) and thick drop (type and parasitaemia)	Day 21
Secondary	Patient outcomes	Association of CRP values and white blood cell counts with patient outcomes	Day 21
Secondary	Specific etiologies	Association of CRP and WBC values with specific etiologies (malaria, bacteremia, dengue,...)	Day 21