Prevalence and Incidence of Lassa Virus Infection in Southern Mali (NCT03783143) | Clinical Trial Compass
CompletedNot Applicable
Prevalence and Incidence of Lassa Virus Infection in Southern Mali
Mali8,524 participantsStarted 2020-12-04
Plain-language 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.
Who can participate
Age range
6 Months – 110 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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.
. 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Determine the prevalence and
Timeframe: At time of study start
2
Determine the incidence of LF in febrile patients attending health centers in southern Mali
Timeframe: Over 3 years
Trial details
NCT IDNCT03783143
SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
. 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.