Clinical trial NCT06122259: Febrile Illness in Guinea
Official title: Multidisciplinary Surveillance and Investigation of Febrile Illness in Guinea
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Febrile Illness
Lead sponsor: Centre National de Formation et de Recherche en Sante Rurale
Sponsor class: OTHER_GOV
Collaborators: name: Institute of Tropical Medicine, Belgium
First posted: 2023-11-08
Enrollment: 2500
Sex: ALL
Minimum age (years): 2
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Febrile patients presenting with documented fever (\> 37.5°C, axillary temperature) or reporting fever within the prior 24 hours (≤37.5°C, axillary temperature) at the emergency or outpatient department of the selected health facilities.

Brief summary: To date, the underlying causes of community-acquired fever, particularly non-malarial fever, are insufficiently documented in Guinea. Moreover, diagnostic capacity is limited, leading to inadequate prescription of antibiotics and antimalarials, as well as substantial delay in outbreak recognition. Thus, the investigators undertook a prospective observational multi-centric cohort study of febrile patients presenting at the emergency and outpatient department of selected health centers, districts and regional hospitals in four ecologically distinct sentinel health districts in Guinea.


Eligibility criteria: Inclusion Criteria:

* Age ≥2 months old
* Documented fever (axillary temperature \>37.5°C) at presentation or fever reported within the prior 24 hours
* Availability for follow-up for 21 days
* Willingness and ability of the patient or culturally acceptable representative to give informed consent for participation in the study

Exclusion Criteria:

* History of hospitalization (for \> 48 hours within the last 14 days) at any health facility

Primary outcomes:
measure: Pattern of symptoms and laboratory results at presentation and during follow-up
timeFrame: Day 0 and day 21
measure: Syndromic and/or etiologic diagnoses as established at day 21
timeFrame: Day 0
measure: Pattern and duration of antibiotic use (and other treatments)
timeFrame: Day 0
measure: Immediate or secondary hospital admissions and of secondary/unscheduled visits
timeFrame: Day 0 and day 21
measure: Participants alive (with or without symptoms) or dead at day 21.
timeFrame: Day 21
Secondary outcomes:
measure: White blood cells and C-reactive protein levels at baseline and association with syndromic/etiologic diagnoses and with patient outcome at day 21
timeFrame: Day 0
measure: Association of seasonal, geographical, demographic, clinical and first-line laboratory variables (malaria RDT and smear, biochemistry) with presenting syndromes/main etiologies
timeFrame: Day 0
measure: Confirmed arboviral pathogens and identification of epidemiological/clinical/laboratory predictors
timeFrame: Day 0
measure: Cases fulfilling any of the case definitions of the 20 epidemic-prone infections under surveillance as compared to the final diagnosis and proportion of them timely reported to health authorities
timeFrame: Day 0
Other outcomes:
Locations:
city: Maférinya
country: Guinea
facility: Centre National de Formation et de Recherche en Santé Rurale
state: Forécariah
Study officials:
affiliation: Institute of Tropical Medicine, Antwerp, Belgium
name: Emmanuel Bottieau, MD, MSc, PhD
role: STUDY_DIRECTOR
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