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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Febrile Illness
• Intervention / Treatment: Other: Observational Study

Detailed 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.

• Study Type: Observational
• Enrollment (Anticipated): 400

Contacts and Locations

• Study Contact: Name: Sounkalo DAO, MD; Phone Number: +223 72 27 49 71; Email: sounkalod@icermali.org
• Study Contact Backup: Name: Oumar GUINDO, PharmD, MPH; Phone Number: +22376410338; Email: oumarmguindo@gmail.com

Study Locations

• Mali
  • Bamako, Mali
    • Recruiting
    • University Clinical Research Center (UCRC) / USTTB

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability 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.

Description

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).

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University Clinical Research Center, Mali
• Collaborators: National Institute of Allergy and Infectious Diseases (NIAID)
• Investigators: Principal Investigator: Sounkalo DAO, MD, University of Science, Techniques and Technologies of Bamako, Mali

Study record dates

Study Major Dates

• Study Start (Actual): June 18, 2020
• Primary Completion (Anticipated): June 18, 2023
• Study Completion (Anticipated): June 18, 2023

Study Registration Dates

• First Submitted: June 7, 2022
• First Submitted That Met QC Criteria: June 28, 2022
• First Posted (Actual): July 1, 2022

Study Record Updates

• Last Update Posted (Actual): July 1, 2022
• Last Update Submitted That Met QC Criteria: June 28, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Keywords: Unknown febrile; emerging or; re-emerging infectious disease
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Infections; Communicable Diseases; Communicable Diseases, Emerging
• Other Study ID Numbers: UCRC-001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No