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| Name | Class |
|---|---|
| National Institute of Allergy and Infectious Diseases (NIAID) | NIH |
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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.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Observational Study | Other | 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 |
| 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 |
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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:
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).
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sounkalo DAO, MD | Contact | +223 72 27 49 71 | sounkalod@icermali.org | |
| Oumar GUINDO, PharmD, MPH | Contact | +22376410338 | oumarmguindo@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Sounkalo DAO, MD | University of Science, Techniques and Technologies of Bamako, Mali | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Clinical Research Center (UCRC) / USTTB | Recruiting | Bamako | Mali |
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| ID | Term |
|---|---|
| D021821 | Communicable Diseases, Emerging |
| ID | Term |
|---|---|
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D019370 | Observation |
| ID | Term |
|---|---|
| D008722 | Methods |
| D008919 | Investigative Techniques |
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Blood samples, Other samples
| D013568 |
| Pathological Conditions, Signs and Symptoms |