Malaria Clinical Trial
Official title:
Community Dynamics of Malaria Transmission in Humans and Mosquitoes at the Area of Sabou, Burkina Faso
Verified date | August 1, 2023 |
Source | National Institutes of Health Clinical Center (CC) |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Active, not recruiting |
Enrollment | 608 |
Est. completion date | December 30, 2024 |
Est. primary completion date | December 30, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 6 Months and older |
Eligibility | - 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 last 2 years |
Country | Name | City | State |
---|---|---|---|
Burkina Faso | CMAMK | Sabou | |
Burkina Faso | GRAS | Sabou |
Lead Sponsor | Collaborator |
---|---|
National Institute of Allergy and Infectious Diseases (NIAID) |
Burkina Faso,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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) | Monthly rates of blood smear positive individuals by age over the course of one year | one year |
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