Health Trials

Febrile Illness in Guinea

ConditionFebrile Illness
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age2+
SponsorCentre National de Formation et de Recherche en Sante Rurale

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

Primary outcomes

1

Pattern of symptoms and laboratory results at presentation and during follow-up

Proportion will be estimated

Time frame
Day 0 and day 21
2

Syndromic and/or etiologic diagnoses as established at day 21

Proportion will be estimated

Time frame
Day 0
3

Pattern and duration of antibiotic use (and other treatments)

Proportion and mean or median will be estimated

Time frame
Day 0
4

Immediate or secondary hospital admissions and of secondary/unscheduled visits

Proportion will be estimated

Time frame
Day 0 and day 21

Secondary outcomes

1

White blood cells and C-reactive protein levels at baseline and association with syndromic/etiologic diagnoses and with patient outcome at day 21

Mean or median level will be estimated

Time frame
Day 0
2

Association of seasonal, geographical, demographic, clinical and first-line laboratory variables (malaria RDT and smear, biochemistry) with presenting syndromes/main etiologies

OR or RR will be estimated as appropriate

Time frame
Day 0
3

Confirmed arboviral pathogens and identification of epidemiological/clinical/laboratory predictors

Proportions will be estimated

Time frame
Day 0
4

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

Proportions will be estimated

Time frame
Day 0

Other outcomes

Sponsors and contacts

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Centre National de Formation et de Recherche en Sante Rurale

Lead sponsor

Institute of Tropical Medicine, Belgium

Collaborator

Source ClinicalTrials.gov
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