Prevalence and Incidence of Lassa Virus Infection in Southern Mali

NCT03783143 | Completed

• 2 other identifiers: 99991902919-I-N029
• Study Type: observational
• Target: 8,524
• Locations: 1 country
• Sites: 1

Brief Summary

Background: The disease Lassa fever mostly affects people in Western Africa. It is very similar to other diseases that cause fever, like malaria and yellow fever. People get Lassa fever from mice infected with Lassa virus. It can also be spread from body fluids of people with the disease. Researchers want to learn more about this virus in Mali so they can develop better tools to diagnose and prevent it. Objective: To find out how many people in certain areas of southern Mali have ever had Lassa fever and count how many people get the disease every year. Eligibility: People ages 6 months to 99 years who live in certain areas of Mali Design: Women who are could become pregnant will have a urine pregnancy test at each visit. Participants will be asked questions about their age, if they have ever had a fever, and if they have ever seen mice in or around their home. This will take about 20 minutes. Participants will give a blood sample using a needle in a vein in the arm. Young children will give it by pricking a finger or heel with a needle. Patients with a fever illness will have a medical history and physical exam. They will give blood and nasal swabs 3 times over 21 days. Participants may be asked to come back 1 time each year for up to 3 more years to take another sample of blood and answer more questions.

Conditions

Lassa Virus Infection

Keywords

Febrile; Human; Lassa Fever; Seroconversion; Natural History

Outcome Measures

Primary Outcomes (2)

• Determine the prevalence and

  Determine the prevalence and annual incidence of seroconversion to LASV infection in the general population around each study site in the LASV-endemic area of southern Mali

  At time of study start

• Determine the incidence of LF in febrile patients attending health centers in southern Mali

  Determine the incidence of LF in febrile patients attending health centers in southern Mali over 3 years.

  Over 3 years

Secondary Outcomes (1)

• Determine the biological, clinical, and virologic parameters of LASV-Soromba infection in study participants with LF.

  At time of study start.

Study Arms (2)

Clinical Cohort

This study population will consist of patient volunteers that visit one of our clinical sites with an undiagnosed febrile illness.

Cross-sectional Cohort

This study population will consist of patient volunteers that visit one of our clinical sites with an undiagnosed febrile illness.

Eligibility Criteria

• Age: 6 Months - 110 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Individuals will be randomly identified from village census lists, and a member of the study team will contact the individual by phone or in person about potential participation in the study. In accordance with cultural practices, the individual s entire household will be invited to participate

You may qualify if:

• Age greater than or equal to 6 months to 99 years.
• Resident of one of the study sites for at least 3 months.
• Able to provide informed consent.
• Agrees to allow storage of samples for future research.
• \. No plans to relocate before the study end date.
• Has fever (temperature greater than or equal to 38 degree celcius), or has had antecedent of fever for at least 2 consecutive days at the time of screening.
• One or more of the following:
• Excluded typhoid fever and and has at least 1 of the following symptoms: chest pain, sore throat, headache, muscle pain,vomiting, and diarrhea.
• Shows bleeding or facial edema.
• Does not respond to anti-malarials or antibiotics after 2 days of treatment.
• Had contact with a confirmed LF case within the last 3 weeks.

You may not qualify if:

• Any condition that, in the opinion of the investigator, contraindicates participation in this study, including conditions that could hinder compliance or that could place participants or study staff at increased risk.
• Pregnancy.
• \. Signs or symptoms of fever-associated conditions other than LF, such as urinary tract infection, or any other infection that may cause fever.
• Co-enrollment guidelines: Participants may be co-enrolled in other studies; however, study staff should be notified of co-enrollment

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead

Study Sites (1)

Icer/Mrtc/Fmos/Usttb

Bamako, Mali

Location

MeSH Terms

Conditions

Lassa Fever; Fever; HIV Seropositivity

Condition Hierarchy (Ancestors)

Arenaviridae Infections; RNA Virus Infections; Virus Diseases; Infections; Hemorrhagic Fevers, Viral; Body Temperature Changes; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; HIV Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Heinrich U Feldmann, M.D.

  National Institute of Allergy and Infectious Diseases (NIAID)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 19, 2018
• First Posted: December 20, 2018
• Study Start: December 4, 2020
• Primary Completion: July 25, 2024
• Study Completion: July 25, 2024
• Last Updated: August 1, 2025

Record last verified: 2025-07-17

Data Sharing

• IPD Sharing: Will not share

Locations

MA (1)