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NCT Number: NCT06122259

Febrile Illness in Guinea

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.

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Key information

Conditions

Febrile Illness

Age range

2 month and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Centre National de Formation et de Recherche en Santé Rurale

Maférinya, Forécariah, 2649, Guinea

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

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

    Time frame: Day 0 and day 21

    Proportion will be estimated

  2. Syndromic and/or etiologic diagnoses as established at day 21

    Time frame: Day 0

    Proportion will be estimated

  3. Pattern and duration of antibiotic use (and other treatments)

    Time frame: Day 0

    Proportion and mean or median will be estimated

  4. Immediate or secondary hospital admissions and of secondary/unscheduled visits

    Time frame: Day 0 and day 21

    Proportion will be estimated

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

    Time frame: Day 21

    Survival or mortality rate will be estimated

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

    Time frame: 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

    Time frame: Day 0

    OR or RR will be estimated as appropriate

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

    Time frame: 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

    Time frame: Day 0

    Proportions will be estimated

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Sponsors and collaborators

Lead sponsor

Centre National de Formation et de Recherche en Sante Rurale

Other Gov

Collaborators

  • Institute of Tropical Medicine, Belgium

Registry information

Official study title

Multidisciplinary Surveillance and Investigation of Febrile Illness in Guinea

Acronym: MuSIFe

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Nov 8, 2023
Registry last updated
Nov 8, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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