Febrile Illness in Kinshasa and Kimpese (FIKI²)

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

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.

Study Overview

• Status: Completed
• Conditions: Febrile Illness
• Intervention / Treatment: Other: Observational study

• Study Type: Observational
• Enrollment (Actual): 1046

Contacts and Locations

Study Locations

• Congo, The Democratic Republic of the
  • Kinshasa, Congo, The Democratic Republic of the
    • Hôpital General de Kinshasa
  • Kongo Central
    • Kimpese, Kongo Central, Congo, The Democratic Republic of the
      • IME Kimpese

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 months and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of Survival With Symptom Resolution	Proportion of survival with symptom resolution assessed at day 7, of febrile illnesses	Day 7
Proportion of Survival Without Symptom Resolution	Proportion of survival without symptom resolution assessed at day 7, of febrile illnesses	Day 7
Proportion of Death	Proportion of death assessed at day 7, of febrile illnesses	Day 7
Proportion of Survival With Symptom Resolution	Proportion of survival with symptom resolution assessed at day 14, in febrile illnesses	Day 14
Proportion of Survival Without Symptom Resolution	Proportion of survival without symptom resolution assessed at day 14, in febrile illnesses	Day 14
Proportion of Death	Proportion of death assessed at day 14, in febrile ilnesses	Day 14
Proportion of Survival Without Symptom Resolution	Proportion of survival without symptom resolution assessed at day 21, in febrile illnesses	Day 21
Proportion of Death	Proportion of death assessed at day 21, in febrile illnesses	Day 21
Proportion of Participants With Initial Hospitalization	Proportion of participants with initial hospitalization (assessed at Day 21)	Day 21
Proportion of Participants With Secondary Hospitalization	Proportion of participants with secondary hospitalization assessed at day 21	Day 21
Length of Hospital Stay (Initial and/or Secondary Hospitalization)	Length of hospital stay (initial and/or secondary hospitalization) assessed at day 21	Day 21
Number of Secondary Visits	Number of secondary visits (assessed at Day 21).	Day 21
Patient Outcomes	Association of CRP values and white blood cell counts with patient outcomes	Day 21
Severity of Illness	Severity of illness on day 0 as assessed by the ASAPS/IGSA (Simplified ambulatory severity index) score in adult febrile illnesses. IGSA is a clinical severity score designed to estimate the prognosis of patients in emergency settings. It is based on six clinical parameters: age, heart rate (pulse), systolic blood pressure, respiratory rate, body temperature, and Glasgow Coma Scale score. Each parameter is assigned a score from 0 to 4 based on the severity of the observed abnormality. The total score is the sum of the individual scores for each parameter, with a theoretical maximum of 24 points. The ASAPS/IGSA score can be calculated with a calculator via the website of société Française de Médecine d'urgence. A value between 0 and 24 is expected, it's life-threatening if ≥ 8. The lower the total score, the more favorable the prognosis.	Day 0
Severity of Illness	Severity of illness on day 0 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; point: Moderate risk; consider monitoring and reassessment; or 3 points: High risk; prompt evaluation and intervention recommended	Day 0
Severity of Illness	Severity of illness on day 7 as assessed by the ASAPS/IGSA score (Simplified ambulatory severity index score) in adult febrile illnesses. IGSA is a clinical severity score designed to estimate the prognosis of patients in emergency settings. It is based on six clinical parameters: age, heart rate (pulse), systolic blood pressure, respiratory rate, body temperature, and Glasgow Coma Scale score. Each parameter is assigned a score from 0 to 4 based on the severity of the observed abnormality. The total score is the sum of the individual scores for each parameter, with a theoretical maximum of 24 points. The ASAPS/IGSA score can be calculated with a calculator via the website of société Française de Médecine d'urgence. A value between 0 and 24 is expected, it's life-threatening if ≥ 8. The lower the total score, the more favorable the prognosis.	day 7
Severity of Illness	Severity of illness on day 7 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; point: Moderate risk; consider monitoring and reassessment; or 3 points: High risk; prompt evaluation and intervention recommended	Day 7
Severity of Illness	Severity of illness on day 14 as assessed by the ASAPS/IGSA (Simplified ambulatory severity index) score in adult febrile illnesses. IGSA is a clinical severity score designed to estimate the prognosis of patients in emergency settings. It is based on six clinical parameters: age, heart rate (pulse), systolic blood pressure, respiratory rate, body temperature, and Glasgow Coma Scale score. Each parameter is assigned a score from 0 to 4 based on the severity of the observed abnormality. The total score is the sum of the individual scores for each parameter, with a theoretical maximum of 24 points. The ASAPS/IGSA score can be calculated with a calculator via the website of société Française de Médecine d'urgence. A value between 0 and 24 is expected, it's life-threatening if ≥ 8. The lower the total score, the more favorable the prognosis.	Day 14
Severity of Illness	Severity of illness on day 14 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; point: Moderate risk; consider monitoring and reassessment; or 3 points: High risk; prompt evaluation and intervention recommended	Day 14
Severity of Illness	Severity of illness on day 21 as assessed by the ASAPS/IGSA (Simplified ambulatory severity index) score in adult febrile illnesses. IGSA is a clinical severity score designed to estimate the prognosis of patients in emergency settings. It is based on six clinical parameters: age, heart rate (pulse), systolic blood pressure, respiratory rate, body temperature, and Glasgow Coma Scale score. Each parameter is assigned a score from 0 to 4 based on the severity of the observed abnormality. The total score is the sum of the individual scores for each parameter, with a theoretical maximum of 24 points. The ASAPS/IGSA score can be calculated with a calculator via the website of société Française de Médecine d'urgence. A value between 0 and 24 is expected, it's life-threatening if ≥ 8. The lower the total score, the more favorable the prognosis.	Day 21
Severity of Illness	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; point: Moderate risk; consider monitoring and reassessment; or 3 points: High risk; prompt evaluation and intervention recommended	Day 21
Frequency of Malaria	Frequency of malaria as detected by rapid test (HRP II antigen) at day 21 in febrile illnesses	Day 21
Frequency of Malaria	Frequency of malaria as detected by rapid test (pLDH antigen) at day 21 in febrile illnesses	Day 21
Frequency of Malaria	Frequency of malaria as detected by thick smear positivity at day 21 in febrile illnesses	Day 21
Frequency of Malaria	Frequency of malaria type Plasmodium falciparum as detected by thick smear at day 21	Day 21
Parasitemia of Malaria	Parasitemia as detected by thick smear at day 21 in febrile illnesses	Day 21
Frequency of Malaria	Frequency of malaria type Plasmodium malariae as detected by thick smear at day 21	Day 21

Collaborators and Investigators

• Sponsor: Institute of Tropical Medicine, Belgium
• Collaborators: Institut National de Recherche Biomédicale. Kinshasa, République Démocratique du Congo
• Investigators: Principal Investigator: Emmanuel Bottieau, MD, Institute of Tropical Medicine

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2021
• Primary Completion (Actual): September 18, 2023
• Study Completion (Actual): September 18, 2023

Study Registration Dates

• First Submitted: February 12, 2021
• First Submitted That Met QC Criteria: February 17, 2021
• First Posted (Actual): February 18, 2021

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 12, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Body Temperature Changes; Heat Stress Disorders; Hyperthermia; Fever
• Other Study ID Numbers: FIKI²

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No