NCT05441800

Brief Summary

This is a prospective observational study to include participants with a spectrum of emerging or unknown pathogens with the objective to determine etiology and clinical characteristics of those diseases.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
400

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2020

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 18, 2020

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

June 7, 2022

Completed
24 days until next milestone

First Posted

Study publicly available on registry

July 1, 2022

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 18, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 18, 2023

Completed
Last Updated

July 1, 2022

Status Verified

June 1, 2022

Enrollment Period

3 years

First QC Date

June 7, 2022

Last Update Submit

June 28, 2022

Conditions

Keywords

Unknown febrileemerging orre-emerging infectious disease

Outcome Measures

Primary Outcomes (1)

  • Identify the etiologies and immediate outcomes of emerging and re-emerging diseases in Mali.

    To identify the etiologies (e.g. lassa fever, measles, covid-19, zika, Ebola virus disease) of unexplained febrile illnesses in adults and children in Mali measured by the proportion of cases identified who are children, or who are adults.

    In 3 years

Interventions

observational study to include participants with a spectrum of emerging or unknown pathogens with the objective to determine etiology and clinical characteristics of those diseases

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Subjects enrolled in this study will be identified by the National Epidemiological Monitoring Committee, the Department of Infectious and Tropical Diseases, or other services of the level-3 hospitals in the context of public health emergency or epidemic. Participants will be suspected of having a febrile illness due to an infectious pathogen that has not been formally identified by existing diagnostic strategies or standard of care testing.

You may not qualify if:

  • \- Participants may be excluded from enrolling in the study if they have any known medical disorders or other circumstances which, in the opinion of the investigator, might make participation unsafe or difficult (e.g. inability to obtain necessary samples, mental illness).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Clinical Research Center (UCRC) / USTTB

Bamako, Mali

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples, Other samples

MeSH Terms

Conditions

Communicable Diseases, Emerging

Interventions

Observation

Condition Hierarchy (Ancestors)

Communicable DiseasesInfectionsDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

MethodsInvestigative Techniques

Study Officials

  • Sounkalo DAO, MD

    University of Science, Techniques and Technologies of Bamako, Mali

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Oumar GUINDO, PharmD, MPH

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Month
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 7, 2022

First Posted

July 1, 2022

Study Start

June 18, 2020

Primary Completion

June 18, 2023

Study Completion

June 18, 2023

Last Updated

July 1, 2022

Record last verified: 2022-06

Locations