Trial Outcomes & Findings for Febrile Illness in Kinshasa and Kimpese (NCT NCT04760678)

Results Overview

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

Recruitment status

COMPLETED

Target enrollment

1046 participants

Primary outcome timeframe

Day 21

Results posted on

2025-03-06

Participant Flow

Participant milestones

Participant milestones
Measure	All Participants all adults and children presenting to emergency departments or outpatient clinic with community-acquired febrile illness (HGKinshasa children, HGRKimpese adults, HGR Kimpese children)
Overall Study STARTED	1046
Overall Study COMPLETED	984
Overall Study NOT COMPLETED	62

Reasons for withdrawal

Reasons for withdrawal
Measure	All Participants all adults and children presenting to emergency departments or outpatient clinic with community-acquired febrile illness (HGKinshasa children, HGRKimpese adults, HGR Kimpese children)
Overall Study Death	13
Overall Study Lost to Follow-up	48
Overall Study Withdrawal by Subject	1

Baseline Characteristics

Febrile Illness in Kinshasa and Kimpese

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Participants n=997 Participants all adults and children presenting to emergency departments or outpatient clinic with community-acquired febrile illness (HGKinshasa children, HGRKimpese adults, HGR Kimpese children)
Age, Continuous	5 years n=5 Participants
Sex: Female, Male Female	467 Participants n=5 Participants
Sex: Female, Male Male	530 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	997 Participants n=5 Participants
Education None	2 Participants n=5 Participants
Education Child going to school	468 Participants n=5 Participants
Education Missing	413 Participants n=5 Participants
Education primary	1 Participants n=5 Participants
Education secondary	58 Participants n=5 Participants
Education superior	50 Participants n=5 Participants
Education unknown	5 Participants n=5 Participants
Temperature	37.8 degrees celcius n=5 Participants
Height	118 cm n=5 Participants
Weight	19 kg n=5 Participants
Brachial Perimeter	15 cm n=5 Participants
Diastolic blood pressure	70 mm Hg n=5 Participants
Syst. Blood pressure	108 mm Hg n=5 Participants
Heart rate	108 BPM n=5 Participants
Breathing rate	28 breaths per minute n=5 Participants
SpO2	98 % n=5 Participants
Previous consultation both	7 Participants n=5 Participants
Previous consultation formal system	72 Participants n=5 Participants
Previous consultation informal system	11 Participants n=5 Participants
Previous consultation neither	907 Participants n=5 Participants
Previous treatment yes	875 Participants n=5 Participants
Previous treatment no	113 Participants n=5 Participants
Previous treatment unknown	9 Participants n=5 Participants
Antimalarial no	843 Participants n=5 Participants
Antimalarial yes	154 Participants n=5 Participants
Antibiotic no	873 Participants n=5 Participants
Antibiotic yes	124 Participants n=5 Participants
Fever duration	3 days n=5 Participants

PRIMARY outcome

Timeframe: Day 21

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

Outcome measures

Outcome measures
Measure	All Participants n=977 Participants all adults and children presenting to emergency departments or outpatient clinic with community-acquired febrile illness (HGKinshasa children, HGRKimpese adults, HGR Kimpese children)
Proportion of Survival With Symptom Resolution	96.9 percentage of participants Interval 95.6 to 97.8

PRIMARY outcome

Timeframe: Day 0

CRP values at day 0 (inclusion)

Outcome measures

Outcome measures
Measure	All Participants n=997 Participants all adults and children presenting to emergency departments or outpatient clinic with community-acquired febrile illness (HGKinshasa children, HGRKimpese adults, HGR Kimpese children)
CRP Values	20 mg/L Interval 6.0 to 77.25

PRIMARY outcome

Timeframe: day 0

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

Outcome measures

Outcome measures
Measure	All Participants n=997 Participants all adults and children presenting to emergency departments or outpatient clinic with community-acquired febrile illness (HGKinshasa children, HGRKimpese adults, HGR Kimpese children)
White Blood Cell Count	7 10^9 cells/L Interval 5.1 to 9.7

SECONDARY outcome

Timeframe: Day 7

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

Outcome measures

Outcome measures
Measure	All Participants n=970 Participants all adults and children presenting to emergency departments or outpatient clinic with community-acquired febrile illness (HGKinshasa children, HGRKimpese adults, HGR Kimpese children)
Proportion of Survival With Symptom Resolution	93.9 percentage of participants Interval 92.2 to 95.3

SECONDARY outcome

Timeframe: Day 7

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

Outcome measures

Outcome measures
Measure	All Participants n=970 Participants all adults and children presenting to emergency departments or outpatient clinic with community-acquired febrile illness (HGKinshasa children, HGRKimpese adults, HGR Kimpese children)
Proportion of Survival Without Symptom Resolution	5.2 percentage of participants Interval 3.9 to 6.7

SECONDARY outcome

Timeframe: Day 7

Proportion of death assessed at day 7, of febrile illnesses

Outcome measures

Outcome measures
Measure	All Participants n=970 Participants all adults and children presenting to emergency departments or outpatient clinic with community-acquired febrile illness (HGKinshasa children, HGRKimpese adults, HGR Kimpese children)
Proportion of Death	0.9 percentage of participants Interval 0.5 to 1.8

SECONDARY outcome

Timeframe: Day 14

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

Outcome measures

Outcome measures
Measure	All Participants n=977 Participants all adults and children presenting to emergency departments or outpatient clinic with community-acquired febrile illness (HGKinshasa children, HGRKimpese adults, HGR Kimpese children)
Proportion of Survival With Symptom Resolution	95.7 percentage of participants Interval 94.2 to 96.8

SECONDARY outcome

Timeframe: Day 14

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

Outcome measures

Outcome measures
Measure	All Participants n=977 Participants all adults and children presenting to emergency departments or outpatient clinic with community-acquired febrile illness (HGKinshasa children, HGRKimpese adults, HGR Kimpese children)
Proportion of Survival Without Symptom Resolution	3.2 percentage of participants Interval 2.2 to 4.5

SECONDARY outcome

Timeframe: Day 14

Proportion of death assessed at day 14, in febrile ilnesses

Outcome measures

Outcome measures
Measure	All Participants n=977 Participants all adults and children presenting to emergency departments or outpatient clinic with community-acquired febrile illness (HGKinshasa children, HGRKimpese adults, HGR Kimpese children)
Proportion of Death	1.1 percentage of participants Interval 0.6 to 2.0

SECONDARY outcome

Timeframe: Day 21

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

Outcome measures

Outcome measures
Measure	All Participants n=997 Participants all adults and children presenting to emergency departments or outpatient clinic with community-acquired febrile illness (HGKinshasa children, HGRKimpese adults, HGR Kimpese children)
Proportion of Survival Without Symptom Resolution	1.8 percentage of participants Interval 1.1 to 2.8

SECONDARY outcome

Timeframe: Day 21

Proportion of death assessed at day 21, in febrile illnesses

Outcome measures

Outcome measures
Measure	All Participants n=997 Participants all adults and children presenting to emergency departments or outpatient clinic with community-acquired febrile illness (HGKinshasa children, HGRKimpese adults, HGR Kimpese children)
Proportion of Death	1.3 percentage of participants Interval 0.8 to 2.2

SECONDARY outcome

Timeframe: Day 21

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

Outcome measures

Outcome measures
Measure	All Participants n=997 Participants all adults and children presenting to emergency departments or outpatient clinic with community-acquired febrile illness (HGKinshasa children, HGRKimpese adults, HGR Kimpese children)
Proportion of Participants With Initial Hospitalization	13.3 percentage of participants Interval 11.4 to 15.6

SECONDARY outcome

Timeframe: Day 21

Proportion of participants with secondary hospitalization assessed at day 21

Outcome measures

Outcome measures
Measure	All Participants n=997 Participants all adults and children presenting to emergency departments or outpatient clinic with community-acquired febrile illness (HGKinshasa children, HGRKimpese adults, HGR Kimpese children)
Proportion of Participants With Secondary Hospitalization	1.1 percentage of participants Interval 0.6 to 2.0

SECONDARY outcome

Timeframe: Day 21

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

Outcome measures

Outcome measures
Measure	All Participants n=997 Participants all adults and children presenting to emergency departments or outpatient clinic with community-acquired febrile illness (HGKinshasa children, HGRKimpese adults, HGR Kimpese children)
Length of Hospital Stay (Initial and/or Secondary Hospitalization)	5 days Interval 3.0 to 8.0

SECONDARY outcome

Timeframe: Day 21

Number of secondary visits (assessed at Day 21).

Outcome measures

Outcome measures
Measure	All Participants n=997 Participants all adults and children presenting to emergency departments or outpatient clinic with community-acquired febrile illness (HGKinshasa children, HGRKimpese adults, HGR Kimpese children)
Number of Secondary Visits	4 visits Interval 4.0 to 4.0

SECONDARY outcome

Timeframe: Day 21

Population: overal number of pts analyzed = number resolved + number non resolved

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

Outcome measures

Outcome measures
Measure	All Participants n=984 Participants all adults and children presenting to emergency departments or outpatient clinic with community-acquired febrile illness (HGKinshasa children, HGRKimpese adults, HGR Kimpese children)
Patient Outcomes CRP clinical outcome Resolution	19 mg/L Interval 6.0 to 72.0
Patient Outcomes CRP clinical outcome Non-resolution	71 mg/L Interval 13.0 to 87.5

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	All Participants n=121 Participants all adults and children presenting to emergency departments or outpatient clinic with community-acquired febrile illness (HGKinshasa children, HGRKimpese adults, HGR Kimpese children)
Severity of Illness	2 score on a scale Interval 1.0 to 4.0

SECONDARY outcome

Timeframe: 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 1. point: Moderate risk; consider monitoring and reassessment 2. or 3 points: High risk; prompt evaluation and intervention recommended

Outcome measures

Outcome measures
Measure	All Participants n=121 Participants all adults and children presenting to emergency departments or outpatient clinic with community-acquired febrile illness (HGKinshasa children, HGRKimpese adults, HGR Kimpese children)
Severity of Illness	1 score on a scale Interval 0.0 to 2.0

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	All Participants n=23 Participants all adults and children presenting to emergency departments or outpatient clinic with community-acquired febrile illness (HGKinshasa children, HGRKimpese adults, HGR Kimpese children)
Severity of Illness	0 score on a scale Interval 0.0 to 1.5

SECONDARY outcome

Timeframe: 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 1. point: Moderate risk; consider monitoring and reassessment 2. or 3 points: High risk; prompt evaluation and intervention recommended

Outcome measures

Outcome measures
Measure	All Participants n=23 Participants all adults and children presenting to emergency departments or outpatient clinic with community-acquired febrile illness (HGKinshasa children, HGRKimpese adults, HGR Kimpese children)
Severity of Illness	1 score on a scale Interval 0.0 to 1.0

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	All Participants n=12 Participants all adults and children presenting to emergency departments or outpatient clinic with community-acquired febrile illness (HGKinshasa children, HGRKimpese adults, HGR Kimpese children)
Severity of Illness	1.5 score on a scale Interval 0.0 to 2.25

SECONDARY outcome

Timeframe: 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 1. point: Moderate risk; consider monitoring and reassessment 2. or 3 points: High risk; prompt evaluation and intervention recommended

Outcome measures

Outcome measures
Measure	All Participants n=12 Participants all adults and children presenting to emergency departments or outpatient clinic with community-acquired febrile illness (HGKinshasa children, HGRKimpese adults, HGR Kimpese children)
Severity of Illness	1 score on a scale Interval 0.0 to 1.0

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	All Participants n=17 Participants all adults and children presenting to emergency departments or outpatient clinic with community-acquired febrile illness (HGKinshasa children, HGRKimpese adults, HGR Kimpese children)
Severity of Illness	1 score on a scale Interval 0.0 to 2.0

SECONDARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	All Participants n=17 Participants all adults and children presenting to emergency departments or outpatient clinic with community-acquired febrile illness (HGKinshasa children, HGRKimpese adults, HGR Kimpese children)
Severity of Illness	1 score on a scale Interval 0.0 to 1.0

SECONDARY outcome

Timeframe: Day 21

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

Outcome measures

Outcome measures
Measure	All Participants n=774 Participants all adults and children presenting to emergency departments or outpatient clinic with community-acquired febrile illness (HGKinshasa children, HGRKimpese adults, HGR Kimpese children)
Frequency of Malaria	31.6 percentage of participants Interval 28.3 to 35.0

SECONDARY outcome

Timeframe: Day 21

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

Outcome measures

Outcome measures
Measure	All Participants n=774 Participants all adults and children presenting to emergency departments or outpatient clinic with community-acquired febrile illness (HGKinshasa children, HGRKimpese adults, HGR Kimpese children)
Frequency of Malaria	22.3 percentage of participants Interval 19.5 to 25.4

SECONDARY outcome

Timeframe: Day 21

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

Outcome measures

Outcome measures
Measure	All Participants n=790 Participants all adults and children presenting to emergency departments or outpatient clinic with community-acquired febrile illness (HGKinshasa children, HGRKimpese adults, HGR Kimpese children)
Frequency of Malaria	25.3 percentage of participants Interval 22.3 to 28.6

SECONDARY outcome

Timeframe: Day 21

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

Outcome measures

Outcome measures
Measure	All Participants n=790 Participants all adults and children presenting to emergency departments or outpatient clinic with community-acquired febrile illness (HGKinshasa children, HGRKimpese adults, HGR Kimpese children)
Frequency of Malaria	24.3 percentage of participants Interval 21.4 to 27.5

SECONDARY outcome

Timeframe: Day 21

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

Outcome measures

Outcome measures
Measure	All Participants n=790 Participants all adults and children presenting to emergency departments or outpatient clinic with community-acquired febrile illness (HGKinshasa children, HGRKimpese adults, HGR Kimpese children)
Parasitemia of Malaria	8350 trophozoïtes/microliter Interval 1924.0 to 41892.0

SECONDARY outcome

Timeframe: Day 21

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

Outcome measures

Outcome measures
Measure	All Participants n=790 Participants all adults and children presenting to emergency departments or outpatient clinic with community-acquired febrile illness (HGKinshasa children, HGRKimpese adults, HGR Kimpese children)
Frequency of Malaria	1.1 percentage of participants Interval 0.5 to 2.1

Adverse Events

All Participants

Serious events: 0 serious events

Other events: 0 other events

Deaths: 13 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Carolien Hoof

Insitute of Tropical Medicine

Phone: 0470102562

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place