Febrile Illness in Guinea (MuSIFe)

November 7, 2023 updated by: Karifa Kourouma, Centre National de Formation et de Recherche en Sante Rurale

Multidisciplinary Surveillance and Investigation of 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.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

2500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Guinea
    • Forécariah
      • Maférinya, Forécariah, Guinea, 2649
        • Recruiting
        • Centre National de Formation et de Recherche en Santé Rurale
        • Contact:
        • Contact:
        • Principal Investigator:
          • Karifa Kourouma, MD, MSc
        • Sub-Investigator:
          • Alexandre Delamou, MD, MPH, PhD
        • Sub-Investigator:
          • Abdoul Habib Beavogui, MD, MSc, PhD
        • Sub-Investigator:
          • Emmanuel Bottieau, MD, MSc, PhD
        • Sub-Investigator:
          • Isabel Brosius, MD, MSC
        • Sub-Investigator:
          • Steven Declercq, MD, MPH
        • Sub-Investigator:
          • Koen Vercauteren, PharmaD, MSc, PhD
        • Sub-Investigator:
          • Eugene Bangwen, MPH
        • Sub-Investigator:
          • Laurens Liesenborghs, MD, MSc, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Day 0
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
Day 0
Confirmed arboviral pathogens and identification of epidemiological/clinical/laboratory predictors
Time Frame: Day 0
Proportions will be estimated
Day 0
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
Day 0

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre National de Formation et de Recherche en Sante Rurale

Collaborators

Institute of Tropical Medicine, Belgium

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 27, 2023

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

November 1, 2023

First Submitted That Met QC Criteria

November 7, 2023

First Posted (Estimated)

November 8, 2023

Study Record Updates

Last Update Posted (Estimated)

November 8, 2023

Last Update Submitted That Met QC Criteria

November 7, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB/RR/AC/041_1616/22_ITM
  • 139/CNERS/23 (Other Identifier: Comité National d'Ethique pour la Recherche en Santé, Guinea)
  • IRB/RR/AC/041_1616/22 (Other Identifier: Institutional Review Board of the Institute of Tropical Medicine, Antwerp, Belgium)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

This is under development and will be filled when finalized.

IPD Sharing Time Frame

Yet to be finalized.

IPD Sharing Access Criteria

Yet to be finalized. However, investigators are opened to collaborate on that data that will be generated.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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