Epidemiology and Clinical Characteristics of Emerging and Re-emerging Infectious Diseases With Epidemic Potential in Mali

Febrile Illness Clinical Trial

— ECERID  

Official title:

Epidemiology and Clinical Characteristics of Emerging and Re-emerging Infectious Diseases

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05441800
• Other study ID #: UCRC-001
• Status: Recruiting
• Start date: June 18, 2020
• Est. completion date: June 18, 2023

Study information

• Verified date: June 2022
• Source: University Clinical Research Center, Mali
• Contact: Sounkalo DAO, MD
• Phone: +223 72 27 49 71
• Email: sounkalod[@]icermali.org
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Description:

Infectious diseases remain one of the leading causes of death worldwide despite innovations in medical research and the availability of new treatments. Emerging diseases include outbreaks of previously unknown diseases or known diseases where the incidence in humans has significantly increased in the past two decades. Detailed studies on emerging and re-emerging infectious agents to better understand pathogens' biology and host pathogenesis are mostly lacking. This study protocol is to prepare for a rapid coordinated clinical investigation of acute infections of emerging and re-emerging infectious agents in Mali. In collaboration with the Mali Ministry of Health and Public Hygiene, we will conduct an 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. Patients with suspected emerging or re-emerging infectious diseases within 15 km of Point G Hospital in Bamako will be invited to participate in this study.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: June 18, 2023
• Est. primary completion date: June 18, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Participants referred or managed by the National Disease Surveillance Committee, primary healthcare facilities, level-3 hospitals, or other facilities Adults and children of any age

Unexplained fever (temperature greater than or equal to 38°C), recorded or reported, within 24 to 48 hours, regardless duration with at least one of the following signs or symptoms:

• Unexplained bleeding

• One or more generic symptoms (headache, tiredness, myalgia, arthralgia, diarrhea, anorexia, weight loss, rash)

• Jaundice

• One or more respiratory symptoms (cough, dyspnea, pharyngitis, rhinorrhea)

• Guillain-Barré syndrome

• Newborns with microcephaly or other brain defects

• Agree to have samples collected and stored for further studies

Exclusion criteria

• 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).

Related Conditions & MeSH terms

• Communicable Diseases
• Communicable Diseases, Emerging
• Febrile Illness
• Infections

Intervention

Other:
• Observational Study
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

Locations

Country	Name	City	State
Mali	University Clinical Research Center (UCRC) / USTTB	Bamako

Sponsors (2)

Lead Sponsor	Collaborator
University Clinical Research Center, Mali	National Institute of Allergy and Infectious Diseases (NIAID)

Country where clinical trial is conducted

Mali, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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