Insecticide-Treated Baby Wraps for the Prevention of Malaria
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age2-99
SponsorUniversity of North Carolina, Chapel Hill
About this trial
The objective is to test the protective effect of permethrin-treated and etofenprox-treated lesus against malaria in young children
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Mother is at least 18 years old
Mother has access to a working phone with a known number
Mother is the parent or legal guardian of a singleton (i.e., not a twin) infant 2-4 months of age
Has the ability to travel to a designated study site for visits and evaluation
Disqualifiers
Participation in another study of malaria prevention
Known allergic reaction to permethrin or etofenprox
Infant has a known HIV diagnosis (or exposure) or sickle cell disease that would be an indication for malaria prophylaxis
Trial design
Design model
Parallel
Treatments tested in this trial
Permethrin-treated lesu
Other interventionPatterned cotton-blend fabric will be obtained and treated with permethrin at Perimeter Insect Guard. After treatment, the material will be cut into 2 x 1 meter swathes
Etofenprox-treated lesu
Other interventionPatterned cotton-blend fabric will be obtained and treated with etofenprox at Perimeter Insect Guard. After treatment, the material will be cut into 2 x 1 meter swathes
Untreated lesu
Other interventionUntreated fabric of identical appearance (i.e., color and pattern) will be similarly cut and packaged for use
Treatment groups
1,296 Participants
are divided into 3 treatment groupsGroup A: Receives permethrin-treated lesuExperimental treatment 1 intervention
Group B: Receives etofenprox-treated lesuExperimental treatment 1 intervention
Group C: Receives non-treated lesuSham comparator 1 intervention
Trial outcomes
Primary outcomes
1
Incidence of clinical malaria in children between the etofenprox and control arms
Incidence of participants experiencing acute febrile illness AND positive malaria rapid diagnostic test (RDT) at a scheduled or unscheduled study visit.
Time frame
From enrollment through Month 242
Incidence of clinical malaria in children between the permethrin and control arms
Incidence of participants experiencing acute febrile illness AND positive malaria RDT at a scheduled or unscheduled study visit.
Time frame
From enrollment through Month 24Secondary outcomes
1
Incidence of clinical malaria in children between the permethrin and control arms per site
Incidence of participants experiencing acute febrile illness AND positive malaria RDT at a scheduled or unscheduled study visit.
Time frame
From enrollment through Month 242
Incidence of clinical malaria in children between the etofenprox and control arms per site
Incidence of participants experiencing acute febrile illness AND positive malaria RDT at a scheduled or unscheduled study visit.
Time frame
From enrollment through Month 243
Incidence of hospitalizations due to malaria between the permethrin and control arms
Incidence of admissions from clinic after a positive malaria RDT.
Time frame
From enrollment to Month 364
Incidence of hospitalizations due to malaria between the etofenprox and control arms
Incidence of admissions from clinic after a positive malaria RDT.
Time frame
From enrollment to Month 36Sponsors and contacts
Click on the lead sponsor to view all of their trials.
University of North Carolina, Chapel Hill
Lead sponsor
North Carolina State University
Collaborator
Mbarara University of Science and Technology
Collaborator
Source ClinicalTrials.gov
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