MuSIFe: Febrile Illness in Guinea

Sponsor
Centre National de Formation et de Recherche en Sante Rurale (Other)
Overall Status
Recruiting
CT.gov ID
NCT06122259
Collaborator
Institute of Tropical Medicine, Belgium (Other)
2,500
1
45.2
55.3

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational [Patient Registry]
    Anticipated Enrollment :
    2500 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Multidisciplinary Surveillance and Investigation of Febrile Illness in Guinea
    Actual Study Start Date :
    Mar 27, 2023
    Anticipated Primary Completion Date :
    Dec 31, 2026
    Anticipated Study Completion Date :
    Dec 31, 2026

    Outcome Measures

    Primary Outcome Measures

    1. Pattern of symptoms and laboratory results at presentation and during follow-up [Day 0 and day 21]

      Proportion will be estimated

    2. Syndromic and/or etiologic diagnoses as established at day 21 [Day 0]

      Proportion will be estimated

    3. Pattern and duration of antibiotic use (and other treatments) [Day 0]

      Proportion and mean or median will be estimated

    4. Immediate or secondary hospital admissions and of secondary/unscheduled visits [Day 0 and day 21]

      Proportion will be estimated

    5. Participants alive (with or without symptoms) or dead at day 21. [Day 21]

      Survival or mortality rate will be estimated

    Secondary Outcome Measures

    1. 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

    2. 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

    3. Confirmed arboviral pathogens and identification of epidemiological/clinical/laboratory predictors [Day 0]

      Proportions will be estimated

    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 [Day 0]

      Proportions will be estimated

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    2 Months and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Centre National de Formation et de Recherche en Santé Rurale Maférinya Forécariah Guinea 2649

    Sponsors and Collaborators

    • Centre National de Formation et de Recherche en Sante Rurale
    • Institute of Tropical Medicine, Belgium

    Investigators

    • Study Director: Emmanuel Bottieau, MD, MSc, PhD, Institute of Tropical Medicine, Antwerp, Belgium

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Karifa Kourouma, Principal Investigator, Centre National de Formation et de Recherche en Sante Rurale
    ClinicalTrials.gov Identifier:
    NCT06122259
    Other Study ID Numbers:
    • IRB/RR/AC/041_1616/22_ITM
    • 139/CNERS/23
    • IRB/RR/AC/041_1616/22
    First Posted:
    Nov 8, 2023
    Last Update Posted:
    Nov 8, 2023
    Last Verified:
    Nov 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Nov 8, 2023