Febrile IllnessFIKI²NCT04760678
Febrile Illness in Kinshasa and Kimpese
An observational study of Febrile Illness, run by Institute of Tropical Medicine, Belgium at 2 sites in Democratic Republic of the Congo.
Trial 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. Read more about this study
- Who is it for?
- Ages 2 months and older
- Conditions the study is for
- Febrile Illness
- What is being tested?
- Observational study
- How many people
- 1,046 participants
- Where
- 2 sitesDemocratic Republic of the Congo
- Study dates
- 1 Mar 2021to 18 Sep 2023
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 months and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- Children less than two months old
- Hospitalization > 48 h in the last 14 days (to exclude nosocomial fevers)
Trial locations and contacts
2 sites in 1 country.
Democratic Republic of the Congo2 sites
IME Kimpese
Kimpese, Bas-Congo Province
Hôpital General de Kinshasa
Kinshasa
About this study
Official title: 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
Read more
- 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.
- Conditions
- Febrile Illness
- Being tested
- Observational study
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observational studyOther
No intervention (observational study in human participants)
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Survival With Symptom Resolution
Proportion of survival with symptom resolution assessed at day 21, of febrile illnesses
Measured: Day 21
CRP Values
CRP values at day 0 (inclusion)
Measured: Day 0
White Blood Cell Count
white blood cell count with differentiation at day 0 (inclusion)
Measured: day 0
Secondary outcomes (27)
Proportion of Survival With Symptom Resolution
Proportion of survival with symptom resolution assessed at day 7, of febrile illnesses
Measured: Day 7
Proportion of Survival Without Symptom Resolution
Proportion of survival without symptom resolution assessed at day 7, of febrile illnesses
Measured: Day 7
Proportion of Death
Proportion of death assessed at day 7, of febrile illnesses
Measured: Day 7
Proportion of Survival With Symptom Resolution
Proportion of survival with symptom resolution assessed at day 14, in febrile illnesses
Measured: Day 14
Proportion of Survival Without Symptom Resolution
Proportion of survival without symptom resolution assessed at day 14, in febrile illnesses
Measured: Day 14
Proportion of Death
Proportion of death assessed at day 14, in febrile ilnesses
Measured: Day 14
Proportion of Survival Without Symptom Resolution
Proportion of survival without symptom resolution assessed at day 21, in febrile illnesses
Measured: Day 21
Proportion of Death
Proportion of death assessed at day 21, in febrile illnesses
Measured: Day 21
Proportion of Participants With Initial Hospitalization
Proportion of participants with initial hospitalization (assessed at Day 21)
Measured: Day 21
Proportion of Participants With Secondary Hospitalization
Proportion of participants with secondary hospitalization assessed at day 21
Measured: Day 21
Length of Hospital Stay (Initial and/or Secondary Hospitalization)
Length of hospital stay (initial and/or secondary hospitalization) assessed at day 21
Measured: Day 21
Number of Secondary Visits
Number of secondary visits (assessed at Day 21).
Measured: Day 21
Patient Outcomes
Association of CRP values and white blood cell counts with patient outcomes
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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
Measured: Day 21
Frequency of Malaria
Frequency of malaria as detected by rapid test (HRP II antigen) at day 21 in febrile illnesses
Measured: Day 21
Frequency of Malaria
Frequency of malaria as detected by rapid test (pLDH antigen) at day 21 in febrile illnesses
Measured: Day 21
Frequency of Malaria
Frequency of malaria as detected by thick smear positivity at day 21 in febrile illnesses
Measured: Day 21
Frequency of Malaria
Frequency of malaria type Plasmodium falciparum as detected by thick smear at day 21
Measured: Day 21
Parasitemia of Malaria
Parasitemia as detected by thick smear at day 21 in febrile illnesses
Measured: Day 21
Frequency of Malaria
Frequency of malaria type Plasmodium malariae as detected by thick smear at day 21
Measured: Day 21
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2021
- Study start1 Mar 2021
- Primary completion18 Sep 2023
- Study completion18 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Febrile IllnessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,046 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institute of Tropical Medicine, Belgium
- Sponsor type
- University, hospital or other
- Collaborators
- Institut National de Recherche Biomedicale (INRB)
- Responsible party
- Sponsor
- Investigators
- Emmanuel Bottieau, MD, Principal investigator, Institute of Tropical Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04760678
- Sponsor's protocol ID
- FIKI²
- Acronym
- FIKI²
- Status last verified
- Feb 2025
- First submitted
- 12 Feb 2021
- Last updated
- 6 Mar 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Hauner A, Lusala SM, Roge S, Van Reet N, Cnops L, Da Luz RI, Van Esbroeck M, Kapandji M, Kuamfumu MM, Kiabanzawoko O, Phanzu DM, Verle P, Ahuka-Mundeke S, Arien KK. Development and validation of a sample-to-result real time multiplex RT-PCR test for human African trypanosomiasis and arboviral febrile illnesses in the Democratic Republic of the Congo. BMC Infect Dis. 2026 Feb 5;26(1):513. doi: 10.1186/s12879-026-12550-0.
PubMed 41645098
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Aspects, Severity, Management and Outcome of Febrile Illnesses in the Democratic Republic Congo (DRC).
- ClinicalTrials.gov ID
- NCT04760678
- Acronym / sponsor ID
- FIKI² / FIKI²
- Conditions
- Febrile Illness
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,046 participants (actual)
- Lead sponsor
- Institute of Tropical Medicine, BelgiumUniversity, hospital or other
- Collaborators
- Institut National de Recherche Biomedicale (INRB)
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 18 Sep 2023 (actual)
- Study completion
- 18 Sep 2023 (actual)
- First posted
- 18 Feb 2021 (actual)
- Results
- Posted 6 Mar 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 2 months and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- Ongoing and objectified fever at presentation, or documented at home or other health center within 24 hours prior to presentation, defined by:
- 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.
Key exclusion criteria (2 listed)
- Children less than two months old
- Hospitalization > 48 h in the last 14 days (to exclude nosocomial fevers)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Observational studyNo intervention (observational study in human participants) | Other | – |
Primary outcome
Proportion of Survival With Symptom Resolution
Time frame: Day 21
Proportion of survival with symptom resolution assessed at day 21, of febrile illnesses
CRP Values
Time frame: Day 0
CRP values at day 0 (inclusion)
White Blood Cell Count
Time frame: day 0
white blood cell count with differentiation at day 0 (inclusion)
27 secondary outcomes
Proportion of Survival With Symptom Resolution
Time frame: Day 7
Proportion of Survival Without Symptom Resolution
Time frame: Day 7
Proportion of Death
Time frame: Day 7
Proportion of Survival With Symptom Resolution
Time frame: Day 14
Proportion of Survival Without Symptom Resolution
Time frame: Day 14
Proportion of Death
Time frame: Day 14
Proportion of Survival Without Symptom Resolution
Time frame: Day 21
Proportion of Death
Time frame: Day 21
Proportion of Participants With Initial Hospitalization
Time frame: Day 21
Proportion of Participants With Secondary Hospitalization
Time frame: Day 21
Length of Hospital Stay (Initial and/or Secondary Hospitalization)
Time frame: Day 21
Number of Secondary Visits
Time frame: Day 21
Patient Outcomes
Time frame: Day 21
Severity of Illness
Time frame: Day 0
Severity of Illness
Time frame: Day 0
Severity of Illness
Time frame: day 7
Severity of Illness
Time frame: Day 7
Severity of Illness
Time frame: Day 14
Severity of Illness
Time frame: Day 14
Severity of Illness
Time frame: Day 21
Severity of Illness
Time frame: Day 21
Frequency of Malaria
Time frame: Day 21
Frequency of Malaria
Time frame: Day 21
Frequency of Malaria
Time frame: Day 21
Frequency of Malaria
Time frame: Day 21
Parasitemia of Malaria
Time frame: Day 21
Frequency of Malaria
Time frame: Day 21
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 41645098Hauner A, Lusala SM, Roge S, Van Reet N, Cnops L, Da Luz RI, Van Esbroeck M, Kapandji M, Kuamfumu MM, Kiabanzawoko O, Phanzu DM, Verle P, Ahuka-Mundeke S, Arien KK. Development and validation of a sample-to-result real time multiplex RT-PCR test for human African trypanosomiasis and arboviral febrile illnesses in the Democratic Republic of the Congo. BMC Infect Dis. 2026 Feb 5;26(1):513. doi: 10.1186/s12879-026-12550-0.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Emmanuel Bottieau, MD principal investigator
Institute of Tropical Medicine
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Febrile Illness, run by Institute of Tropical Medicine, Belgium at 2 sites in Democratic Republic of the Congo.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Democratic Republic of the Congo. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Mar 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of Survival With Symptom Resolution (time frame: Day 21). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04760678, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2025.