Clinical trial NCT05391230: Permethrin-treated Baby-wraps for the Prevention of Malaria in Children
Official title: IGHID 12128 - Getting Malaria "Off the Backs" of Women and Children in Western Uganda
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Malaria
P. Falciparum
Keywords: Permethrin
Plasmodium Falciparum Infection
Insecticide
Malaria
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: Doris Duke Charitable Foundation
First posted: 2022-05-25
Enrollment: 400
Sex: ALL
Minimum age (years): 6
Maximum age (years): 99
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a double-blind, randomized controlled trial of permethrin-treated lesus to prevent P. falciparum malaria in children 6-18 months of age. Study enrollment conducted at two sites in rural western Uganda. Participants will be randomized to one of two arms: permethrin-treated (intervention) or untreated (control) lesus. Participating mother-infant pairs will receive a new Long-lasting Insecticidal Net and two permethrin-treated or untreated lesus at enrollment. Total sample size will be 400 mother-infant pairs with 200 pairs in each arm. Participants will be followed longitudinally for six months, instructed and incentivized to present to one of the two study clinics when a fever develops, where they will be evaluated, tested, and treated, if positive, for malaria. Participants will attend scheduled clinic visits every two weeks for routine surveillance of adverse effects and tested for asymptomatic infection. Re-treatment and sham re-treatment of lesus will occur monthly.
Primary purpose: PREVENTION

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 in rural western Uganda. Participating mother-infant pairs will receive a new bed net and two permethrin-treated or untreated lesus at enrollment. The total sample size will be 400 mother-infant pairs with 200 pairs in each group. The investigators will follow participants longitudinally for six months. Participants will be instructed and incentivized to present to one of the two study clinics when a fever develops, where they will be evaluated, tested, and treated, if positive, for malaria. Participants will also attend scheduled clinic visits every two weeks for routine surveillance of adverse effects and to test for asymptomatic infection. Re-treatment and sham re-treatment of lesus will occur each month.

Outcome Measures: The primary outcome measure is the incidence rate ratio of clinical (i.e., symptomatic) P. falciparum malaria in infants and children 6 - 24 months of age. Differences in malaria infection between treatment groups will be estimated with the incidence rate ratio, defined as the ratio of the number of clinical malaria episodes per 100 person-weeks at risk in the intervention group relative to the control group. This measure was chosen as it represents the most patient-centered measure of malaria burden, reflecting not only the potential negative health consequences, but also opportunity costs associated with care seeking and treatment.

Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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.

Primary outcomes:
measure: Incidence of clinical malaria in child
timeFrame: 7 days after onset of symptoms
Secondary outcomes:
measure: Change in child's hemoglobin level
timeFrame: (Week 0), Week 12, and Week 24 visits
measure: Change in child's growth parameters
timeFrame: (Week 0), Week 12, and Week 24 visits
measure: Change in child's nutritional status
timeFrame: (Week 0), Week 12, and Week 24 visits using MUAC tape
measure: Prevalence of asymptomatic parasitemia
timeFrame: Every two weeks
measure: Malaria hospitalization
timeFrame: 14 days after onset of symptoms
measure: Incidence of clinical malaria in mother
timeFrame: 7 days after onset of symptoms
measure: Change in mother's hemoglobin level
timeFrame: (Week 0), Week 12, and Week 24 visits
measure: Adverse reaction to permethrin treatment
timeFrame: 7 days after onset
Other outcomes:
Locations:
city: Mbarara
country: Uganda
facility: Mbarara University of Science and Technology (MUST)
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Ross Royce, MD, Msc
role: PRINCIPAL_INVESTIGATOR
References: