Clinical trial NCT05441800: Epidemiology and Clinical Characteristics of Emerging and Re-emerging Infectious Diseases With Epidemic Potential in Mali
Official title: Epidemiology and Clinical Characteristics of Emerging and Re-emerging Infectious Diseases
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Febrile Illness
Keywords: Unknown febrile
emerging or
re-emerging infectious disease
Lead sponsor: University Clinical Research Center, Mali
Sponsor class: OTHER
Collaborators: name: National Institute of Allergy and Infectious Diseases (NIAID)
First posted: 2022-07-01
Enrollment: 400
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility criteria: 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).

Primary outcomes:
measure: Identify the etiologies and immediate outcomes of emerging and re-emerging diseases in Mali.
timeFrame: In 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Bamako
country: Mali
facility: University Clinical Research Center (UCRC) / USTTB
Study officials:
affiliation: University of Science, Techniques and Technologies of Bamako, Mali
name: Sounkalo DAO, MD
role: PRINCIPAL_INVESTIGATOR
References: