Febrile Illness in Kinshasa and Kimpese

NCT04760678 | Completed Results

• 1 other identifier: FIKI²
• Study Type: observational
• Target: 1,046
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Febrile Illness

Outcome Measures

Primary Outcomes (3)

• Proportion of Survival With Symptom Resolution

  Proportion of survival with symptom resolution assessed at day 21, of febrile illnesses

  Day 21

• CRP Values

  CRP values at day 0 (inclusion)

  Day 0

• White Blood Cell Count

  white blood cell count with differentiation at day 0 (inclusion)

  day 0

Secondary Outcomes (27)

• Proportion of Survival With Symptom Resolution

  Day 7

• Proportion of Survival Without Symptom Resolution

  Day 7

• Proportion of Death

  Day 7

• Proportion of Survival With Symptom Resolution

  Day 14

• Proportion of Survival Without Symptom Resolution

  Day 14

Interventions

Observational study OTHER

No intervention (observational study in human participants)

Eligibility Criteria

• Age: 2 Months+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Adults and children presenting to emergency or outpatient departments with community febrile illness (with or without signs of focus) in 2 clinical sites (hospitals) in the DRC.

You may qualify if:

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

You may not qualify if:

• Children less than two months old
• Hospitalization \> 48 h in the last 14 days (to exclude nosocomial fevers)

Sponsors & Collaborators

• Institute of Tropical Medicine, Belgium: lead
• Institut National de Recherche Biomédicale. Kinshasa, République Démocratique du Congo: collaborator

Study Sites (2)

IME Kimpese

Kimpese, Bas-Congo Province, Democratic Republic of the Congo

Location

Hôpital General de Kinshasa

Kinshasa, Democratic Republic of the Congo

Location

MeSH Terms

Interventions

Observation

Intervention Hierarchy (Ancestors)

Methods; Investigative Techniques

Results Point of Contact

• Title: Carolien Hoof
• Organization: Insitute of Tropical Medicine

choof@itg.be

0470102562

Study Officials

• Emmanuel Bottieau, MD

  Institute of Tropical Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

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

Study Record Dates

• First Submitted: February 12, 2021
• First Posted: February 18, 2021
• Study Start: March 1, 2021
• Primary Completion: September 18, 2023
• Study Completion: September 18, 2023
• Last Updated: March 6, 2025
• Results First Posted: March 6, 2025

Record last verified: 2025-02

Locations

DE (2)