Status:
COMPLETED
Permethrin-treated Baby-wraps for the Prevention of Malaria in Children
Lead Sponsor:
University of North Carolina, Chapel Hill
Collaborating Sponsors:
Doris Duke Charitable Foundation
Conditions:
Malaria
P. Falciparum
Eligibility:
All Genders
6-99 years
Phase:
NA
Brief Summary
The scientific objective of this study is to test the protective effect of permethrin-treated lesus against P. falciparum malaria in infants and young children.
Detailed Description
General Study Design: The proposed study is a double-blind, randomized control trial of permethrin-treated lesus to prevent P. falciparum malaria in children 6-24 months of age conducted at two sites ...
Eligibility Criteria
Inclusion
- Provide signed and dated informed consent form (ICF)
- Willing to comply with all study procedures and be available for the duration of the study
- Female of any age with a child 6 to 18 months of age at the time of enrollment
- Resident of village located in Bugoye, Maliba, or Mubuku sub-counties. Recruitment will initially focus on residents of villages within 2 km of study clinics in order to facilitate attendance, but we will not restrict enrollment to residents of these villages.
Exclusion
- Mother or child taking any malaria chemoprevention regimen, including individuals living with HIV or exposed children who are taking cotrimoxazole that may modify risk of malaria
- Child with known sickle cell disease
- Known allergic reactions to components of the study product(s)
- Treatment with another investigational drug or other intervention
- Anything that would place the individual at increased risk or preclude the individual's full compliance with or completion of the study.
Key Trial Info
Start Date :
June 3 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 30 2024
Estimated Enrollment :
400 Patients enrolled
Trial Details
Trial ID
NCT05391230
Start Date
June 3 2022
End Date
November 30 2024
Last Update
July 14 2025
Active Locations (1)
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1
Mbarara University of Science and Technology (MUST)
Mbarara, Uganda, PO Box 1410