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Completed

NCT Number: NCT04760678

Febrile Illness in Kinshasa and Kimpese

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.

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Key information

Conditions

Febrile Illness

Age range

2 month and older

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

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

Treatment and study plan

observational study

Other

No intervention (observational study in human participants)

Primary outcomes

  1. Proportion of Survival With Symptom Resolution

    Time frame: Day 21

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

  2. CRP Values

    Time frame: Day 0

    CRP values at day 0 (inclusion)

  3. White Blood Cell Count

    Time frame: day 0

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

Secondary outcomes

  1. Proportion of Survival With Symptom Resolution

    Time frame: Day 7

    Proportion of survival with symptom resolution assessed at day 7, of febrile illnesses

  2. Proportion of Survival Without Symptom Resolution

    Time frame: Day 7

    Proportion of survival without symptom resolution assessed at day 7, of febrile illnesses

  3. Proportion of Death

    Time frame: Day 7

    Proportion of death assessed at day 7, of febrile illnesses

  4. Proportion of Survival With Symptom Resolution

    Time frame: Day 14

    Proportion of survival with symptom resolution assessed at day 14, in febrile illnesses

  5. Proportion of Survival Without Symptom Resolution

    Time frame: Day 14

    Proportion of survival without symptom resolution assessed at day 14, in febrile illnesses

  6. Proportion of Death

    Time frame: Day 14

    Proportion of death assessed at day 14, in febrile ilnesses

  7. Proportion of Survival Without Symptom Resolution

    Time frame: Day 21

    Proportion of survival without symptom resolution assessed at day 21, in febrile illnesses

  8. Proportion of Death

    Time frame: Day 21

    Proportion of death assessed at day 21, in febrile illnesses

  9. Proportion of Participants With Initial Hospitalization

    Time frame: Day 21

    Proportion of participants with initial hospitalization (assessed at Day 21)

  10. Proportion of Participants With Secondary Hospitalization

    Time frame: Day 21

    Proportion of participants with secondary hospitalization assessed at day 21

  11. Length of Hospital Stay (Initial and/or Secondary Hospitalization)

    Time frame: Day 21

    Length of hospital stay (initial and/or secondary hospitalization) assessed at day 21

  12. Number of Secondary Visits

    Time frame: Day 21

    Number of secondary visits (assessed at Day 21).

  13. Patient Outcomes

    Time frame: Day 21

    Association of CRP values and white blood cell counts with patient outcomes

  14. Severity of Illness

    Time frame: Day 0

    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.

  15. Severity of Illness

    Time frame: Day 0

    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

  16. Severity of Illness

    Time frame: day 7

    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.

  17. Severity of Illness

    Time frame: Day 7

    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

  18. Severity of Illness

    Time frame: Day 14

    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.

  19. Severity of Illness

    Time frame: Day 14

    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

  20. Severity of Illness

    Time frame: Day 21

    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.

  21. Severity of Illness

    Time frame: 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

    • point: Moderate risk; consider monitoring and reassessment
    • or 3 points: High risk; prompt evaluation and intervention recommended

  22. Frequency of Malaria

    Time frame: Day 21

    Frequency of malaria as detected by rapid test (HRP II antigen) at day 21 in febrile illnesses

  23. Frequency of Malaria

    Time frame: Day 21

    Frequency of malaria as detected by rapid test (pLDH antigen) at day 21 in febrile illnesses

  24. Frequency of Malaria

    Time frame: Day 21

    Frequency of malaria as detected by thick smear positivity at day 21 in febrile illnesses

  25. Frequency of Malaria

    Time frame: Day 21

    Frequency of malaria type Plasmodium falciparum as detected by thick smear at day 21

  26. Parasitemia of Malaria

    Time frame: Day 21

    Parasitemia as detected by thick smear at day 21 in febrile illnesses

  27. Frequency of Malaria

    Time frame: Day 21

    Frequency of malaria type Plasmodium malariae as detected by thick smear at day 21

Sponsors and collaborators

Lead sponsor

Institute of Tropical Medicine, Belgium

Other

Collaborators

  • Institut National de Recherche Biomédicale. Kinshasa, République Démocratique du Congo

Registry information

Official study title

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

Acronym: FIKI²

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Feb 18, 2021
Registry last updated
Mar 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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