Clinical trial NCT04760678: Febrile Illness in Kinshasa and Kimpese
Official title: Clinical Aspects, Severity, Management and Outcome of Febrile Illnesses in the Democratic Republic Congo (DRC).
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Febrile Illness
Lead sponsor: Institute of Tropical Medicine, Belgium
Sponsor class: OTHER
Collaborators: name: Institut National de Recherche Biomédicale. Kinshasa, République Démocratique du Congo
First posted: 2021-02-18
Enrollment: 1046
Sex: ALL
Minimum age (years): 2
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

Brief 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. 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.


Eligibility criteria: 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)

Primary outcomes:
measure: Proportion of Survival With Symptom Resolution
timeFrame: Day 21
measure: CRP Values
timeFrame: Day 0
measure: White Blood Cell Count
timeFrame: day 0
Secondary outcomes:
measure: Proportion of Survival With Symptom Resolution
timeFrame: Day 7
measure: Proportion of Survival Without Symptom Resolution
timeFrame: Day 7
measure: Proportion of Death
timeFrame: Day 7
measure: Proportion of Survival With Symptom Resolution
timeFrame: Day 14
measure: Proportion of Survival Without Symptom Resolution
timeFrame: Day 14
measure: Proportion of Death
timeFrame: Day 14
measure: Proportion of Survival Without Symptom Resolution
timeFrame: Day 21
measure: Proportion of Death
timeFrame: Day 21
measure: Proportion of Participants With Initial Hospitalization
timeFrame: Day 21
measure: Proportion of Participants With Secondary Hospitalization
timeFrame: Day 21
measure: Length of Hospital Stay (Initial and/or Secondary Hospitalization)
timeFrame: Day 21
measure: Number of Secondary Visits
timeFrame: Day 21
measure: Patient Outcomes
timeFrame: Day 21
measure: Severity of Illness
timeFrame: Day 0
measure: Severity of Illness
timeFrame: Day 0
measure: Severity of Illness
timeFrame: day 7
measure: Severity of Illness
timeFrame: Day 7
measure: Severity of Illness
timeFrame: Day 14
measure: Severity of Illness
timeFrame: Day 14
measure: Severity of Illness
timeFrame: Day 21
measure: Severity of Illness
timeFrame: Day 21
measure: Frequency of Malaria
timeFrame: Day 21
measure: Frequency of Malaria
timeFrame: Day 21
measure: Frequency of Malaria
timeFrame: Day 21
measure: Frequency of Malaria
timeFrame: Day 21
measure: Parasitemia of Malaria
timeFrame: Day 21
measure: Frequency of Malaria
timeFrame: Day 21
Other outcomes:
Locations:
city: Kimpese
country: Congo, The Democratic Republic of the
facility: IME Kimpese
state: Kongo Central
city: Kinshasa
country: Congo, The Democratic Republic of the
facility: Hôpital General de Kinshasa
Study officials:
affiliation: Institute of Tropical Medicine
name: Emmanuel Bottieau, MD
role: PRINCIPAL_INVESTIGATOR
References: