Malaria Transmission in Humans and Mosquitoes at the Area of Sabou, Burkina Faso (NCT04650815) | Clinical Trial Compass
CompletedNot Applicable
Malaria Transmission in Humans and Mosquitoes at the Area of Sabou, Burkina Faso
Burkina Faso608 participantsStarted 2021-06-10
Plain-language summary
Background:
Malaria is a disease that affects many people in Burkina Faso. It is caused by germs that are spread by mosquito bites. A vaccine that blocks the spread of malaria is important to get rid of the disease. To see if a vaccine works, researchers need to find out how many malaria infections are happening in the community.
Objective:
To learn how often people of all ages who live in Sabou, Burkina Faso, get malaria.
Eligibility:
Healthy people ages 6 months to 65 years who reside in Sabou in a household with adults and children.
Design:
Participants will be screened with questions about their health. They will have a physical exam.
Participants will be asked about any malaria symptoms they are having. They will be asked about the use of bed nets. Their vital signs, like blood pressure and temperature, will be measured.
They will have blood taken from their arm with a needle.
Participants who have a fever will have a malaria test. Those who test positive for malaria will be referred to the local health facility for treatment.
Participants will have monthly study visits. Blood will be taken from a finger.
Participants may be invited to take part in 2 mosquito feeding experiments. Mosquitos that do not carry malaria will bite their arm. And a small amount of blood will be fed to mosquitos in a laboratory.
Participants' homes will be examined for mosquitoes. Researchers will remove all mosquitoes they collect. Participants' homes will be sprayed with a chemical to kill mosquitoes and other insects.
Participation will last for 12 months.
Who can participate
Age range
6 Months
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.
* HOUSEHOLD INCLUSION CRITERIA:
In order to be included in the study, households must meet all of the following inclusion criteria:
* Household with at least 3 residents eligible for participation.
* Household with at least one compound member who is below 5 years of age whose parents or caretakers are willing to provide informed consent for the child to participate
* Household with at least one compound member aged 5-15 years whose parents or caretakers are willing to provide informed consent for the child to participate
* Household members willing to accommodate mosquito sampling in their compound, both indoors and outdoors.
SUBJECT INCLUSION CRITERIA:
* 0.5 to 65 years of age
* Known resident within the study area and planning to remain for the duration of the study
* Acceptance and signature of the written informed consent and the assent for children aged 12-19 years who are not otherwise emancipated
SUBJECT EXCLUSION CRITERIA:
* Major congenital defect diagnosed based on medical history and examination
* Behavioral, cognitive, or psychiatric disease that in the opinion of the investigator affects the ability of the subject to understand and cooperate with the study protocol.
* Other condition that, in the opinion of the investigator, would jeopardize the safety or rights of a volunteer participating in the trial or would render the subject unable to comply with the protocol.
* Current participation in malaria vaccine trials or participation in such trials in the la…
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
Measurement of blood smear positive individuals by age over the course of one year. These estimates will be stratified by age brackets of transmission interest (0.5-5, 5-10, 10-18, 19+ years old)
Timeframe: one year
Trial details
NCT IDNCT04650815
SponsorNational Institute of Allergy and Infectious Diseases (NIAID)