Febrile Illness in Kinshasa and Kimpese

Completed

• Conditions: Febrile Illness

• Registration Number: NCT04760678
• Lead Sponsor: Institute of Tropical Medicine, Belgium

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-02-12
• Study First Submitted QC: 2021-02-17
• Study First Posted: 2021-02-18
• Study Start: 2021-03-01
• Primary Completion: 2023-09-18
• Study Completion: 2023-09-18
• Results First Submitted: 2024-10-25
• Status Verified: 2025-02
• Results First Submitted QC: 2025-02-12
• Last Update Submitted: 2025-02-12
• Results First Posted: 2025-03-06
• Last Update Posted: 2025-03-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1046

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Proportion of Survival With Symptom Resolution	Day 21	Proportion of survival with symptom resolution assessed at day 21, of febrile illnesses
CRP Values	Day 0	CRP values at day 0 (inclusion)
White Blood Cell Count	day 0	white blood cell count with differentiation at day 0 (inclusion)

Secondary Outcome Measures

Name	Time	Method
Proportion of Survival With Symptom Resolution	Day 14	Proportion of survival with symptom resolution assessed at day 14, in febrile illnesses
Proportion of Survival Without Symptom Resolution	Day 21	Proportion of survival without symptom resolution assessed at day 21, in febrile illnesses
Proportion of Death	Day 21	Proportion of death assessed at day 21, in febrile illnesses
Proportion of Participants With Initial Hospitalization	Day 21	Proportion of participants with initial hospitalization (assessed at Day 21)
Proportion of Participants With Secondary Hospitalization	Day 21	Proportion of participants with secondary hospitalization assessed at day 21
Length of Hospital Stay (Initial and/or Secondary Hospitalization)	Day 21	Length of hospital stay (initial and/or secondary hospitalization) assessed at day 21
Number of Secondary Visits	Day 21	Number of secondary visits (assessed at Day 21).
Patient Outcomes	Day 21	Association of CRP values and white blood cell counts with patient outcomes
Severity of Illness	Day 21	Severity of illness on day 21 as assessed by the qSOFA (Quick Sepsis Related Organ Failure Assessment)score in adult febrile illnesses.; qSOFA is a clinical tool to identify patients with suspected infection who are at greater risk for poor outcomes, such as in-hospital mortality or prolonged intensive care unit (ICU) stays. It is particularly useful in non-ICU settings like emergency departments.; The qSOFA score evaluates 3 clinical criteria, assigning 1 point for each (it's the sum of 3 criteria): * Respiratory Rate: ≥22 breaths per minute.; * Systolic Blood Pressure: ≤100 mmHg.; * Altered Mental Status: Glasgow Coma Scale (GCS) score \<15. Each criterion is scored as follows: 1 point for meeting the threshold of each criterion.; The total qSOFA score ranges from 0-3 points.; Interpretation of Scores: 0 point: Low risk for poor outcomes; 1. point: Moderate risk; consider monitoring and reassessment; 2. or 3 points: High risk; prompt evaluation and intervention recommended
Frequency of Malaria	Day 21	Frequency of malaria type Plasmodium malariae as detected by thick smear at day 21
Parasitemia of Malaria	Day 21	Parasitemia as detected by thick smear at day 21 in febrile illnesses

Trial Locations

Locations (2)

IME Kimpese; 🇨🇩 Kimpese, Kongo Central, Congo, The Democratic Republic of the

Hôpital General de Kinshasa; 🇨🇩 Kinshasa, Congo, The Democratic Republic of the