Febrile Illness in Guinea

Recruiting

• Conditions: Febrile Illness

• Registration Number: NCT06122259
• Lead Sponsor: Centre National de Formation et de Recherche en Sante Rurale

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-03-27
• Status Verified: 2023-11
• Study First Submitted: 2023-11-01
• Study First Submitted QC: 2023-11-07
• Last Update Submitted: 2023-11-07
• Study First Posted: 2023-11-08
• Last Update Posted: 2023-11-08
• Primary Completion: 2026-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 2500

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Pattern of symptoms and laboratory results at presentation and during follow-up	Day 0 and day 21	Proportion will be estimated
Immediate or secondary hospital admissions and of secondary/unscheduled visits	Day 0 and day 21	Proportion will be estimated
Pattern and duration of antibiotic use (and other treatments)	Day 0	Proportion and mean or median will be estimated
Participants alive (with or without symptoms) or dead at day 21.	Day 21	Survival or mortality rate will be estimated
Syndromic and/or etiologic diagnoses as established at day 21	Day 0	Proportion will be estimated

Secondary Outcome Measures

Name	Time	Method
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	Day 0	Proportions will be estimated
Association of seasonal, geographical, demographic, clinical and first-line laboratory variables (malaria RDT and smear, biochemistry) with presenting syndromes/main etiologies	Day 0	OR or RR will be estimated as appropriate
Confirmed arboviral pathogens and identification of epidemiological/clinical/laboratory predictors	Day 0	Proportions will be estimated
White blood cells and C-reactive protein levels at baseline and association with syndromic/etiologic diagnoses and with patient outcome at day 21	Day 0	Mean or median level will be estimated

Trial Locations

Locations (1)

Centre National de Formation et de Recherche en Santé Rurale; 🇬🇳 Maférinya, Forécariah, Guinea