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 Type
OBSERVATIONAL
Enrollment
1,046
No intervention (observational study in human participants)
IME Kimpese
Kimpese, Bas-Congo Province, Democratic Republic of the Congo
Hôpital General de Kinshasa
Kinshasa, Democratic Republic of the Congo
Proportion of Survival With Symptom Resolution
Proportion of survival with symptom resolution assessed at day 21, of febrile illnesses
Time frame: Day 21
CRP Values
CRP values at day 0 (inclusion)
Time frame: Day 0
White Blood Cell Count
white blood cell count with differentiation at day 0 (inclusion)
Time frame: day 0
Proportion of Survival With Symptom Resolution
Proportion of survival with symptom resolution assessed at day 7, of febrile illnesses
Time frame: Day 7
Proportion of Survival Without Symptom Resolution
Proportion of survival without symptom resolution assessed at day 7, of febrile illnesses
Time frame: Day 7
Proportion of Death
Proportion of death assessed at day 7, of febrile illnesses
Time frame: Day 7
Proportion of Survival With Symptom Resolution
Proportion of survival with symptom resolution assessed at day 14, in febrile illnesses
Time frame: Day 14
Proportion of Survival Without Symptom Resolution
Proportion of survival without symptom resolution assessed at day 14, in febrile illnesses
Time frame: Day 14
Proportion of Death
Proportion of death assessed at day 14, in febrile ilnesses
Time frame: Day 14
Proportion of Survival Without Symptom Resolution
Proportion of survival without symptom resolution assessed at day 21, in febrile illnesses
Time frame: Day 21
Proportion of Death
Proportion of death assessed at day 21, in febrile illnesses
Time frame: Day 21
Proportion of Participants With Initial Hospitalization
Proportion of participants with initial hospitalization (assessed at Day 21)
Time frame: Day 21
Proportion of Participants With Secondary Hospitalization
Proportion of participants with secondary hospitalization assessed at day 21
Time frame: Day 21
Length of Hospital Stay (Initial and/or Secondary Hospitalization)
Length of hospital stay (initial and/or secondary hospitalization) assessed at day 21
Time frame: Day 21
Number of Secondary Visits
Number of secondary visits (assessed at Day 21).
Time frame: Day 21
Patient Outcomes
Association of CRP values and white blood cell counts with patient outcomes
Time frame: 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.
Time frame: 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 1. point: Moderate risk; consider monitoring and reassessment 2. or 3 points: High risk; prompt evaluation and intervention recommended
Time frame: 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.
Time frame: 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 1. point: Moderate risk; consider monitoring and reassessment 2. or 3 points: High risk; prompt evaluation and intervention recommended
Time frame: 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.
Time frame: 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 1. point: Moderate risk; consider monitoring and reassessment 2. or 3 points: High risk; prompt evaluation and intervention recommended
Time frame: 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.
Time frame: 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 1. point: Moderate risk; consider monitoring and reassessment 2. or 3 points: High risk; prompt evaluation and intervention recommended
Time frame: Day 21
Frequency of Malaria
Frequency of malaria as detected by rapid test (HRP II antigen) at day 21 in febrile illnesses
Time frame: Day 21
Frequency of Malaria
Frequency of malaria as detected by rapid test (pLDH antigen) at day 21 in febrile illnesses
Time frame: Day 21
Frequency of Malaria
Frequency of malaria as detected by thick smear positivity at day 21 in febrile illnesses
Time frame: Day 21
Frequency of Malaria
Frequency of malaria type Plasmodium falciparum as detected by thick smear at day 21
Time frame: Day 21
Parasitemia of Malaria
Parasitemia as detected by thick smear at day 21 in febrile illnesses
Time frame: Day 21
Frequency of Malaria
Frequency of malaria type Plasmodium malariae as detected by thick smear at day 21
Time frame: Day 21
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