Permethrin-treated Baby-wraps for the Prevention of Malaria in Children

Not Applicable

Active, not recruiting

• Conditions: P. Falciparum; Malaria
• Interventions: Other: Untreated lesu; Other: Permethrin-treated lesu

• Registration Number: NCT05391230
• Lead Sponsor: University of North Carolina, Chapel Hill

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.

Study Timeline

• Study First Submitted: 2022-05-20
• Study First Submitted QC: 2022-05-24
• Study First Posted: 2022-05-25
• Study Start: 2022-06-03
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-22
• Last Update Posted: 2024-05-23
• Primary Completion: 2024-10
• Study Completion: 2025-06

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 400

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control Arm: Arm that received none permethrin-treated lesu	Untreated lesu	The lesus of participants in the control group will undergo sham treatment and re-treatment in which the cloth is soaked in water for a period of time similar to that of the intervention group. Participants and clinical staff (but not administrative staff) will be blinded to group assignments.
Intervention Arm : Arm that received permethrin-treated lesu	Permethrin-treated lesu	Intervention Arm is the group that receives permethrin-treated lesu for use. The lesus of participants in the intervention group will be treated and subsequently retreated each month with 0.5% permethrin (Sawyer Products, Safety Harbor, FL).

Primary Outcome Measures

Name	Time	Method
Incidence of clinical malaria in child	7 days after onset of symptoms	The presence of typical symptoms (e.g., fever, lethargy) and a positive malaria Rapid Diagnostic Test (RDT) during observation

Secondary Outcome Measures

Name	Time	Method
Malaria hospitalization	14 days after onset of symptoms	Child admitted to inpatient ward for treatment of malaria
Incidence of clinical malaria in mother	7 days after onset of symptoms	The presence of typical symptoms (e.g., fever, lethargy) and a positive malaria RDT during observation
Change in child's growth parameters	(Week 0), Week 12, and Week 24 visits	Change in child's height and weight (e.g., weight and height will be combined to report BMI in kg/m\^2).
Change in mother's hemoglobin level	(Week 0), Week 12, and Week 24 visits	Change in child's hemoglobin as measured by HemoCue® device
Change in child's hemoglobin level	(Week 0), Week 12, and Week 24 visits	Change in child's hemoglobin as measured by HemoCue® device
Change in child's nutritional status	(Week 0), Week 12, and Week 24 visits using MUAC tape	Change in child's mid-upper arm circumference (MUAC)
Prevalence of asymptomatic parasitemia	Every two weeks	Presence of malaria parasites on bi-weekly dried blood spot (DBS) as determined by quantitative polymerase chain reaction(qPCR).
Adverse reaction to permethrin treatment	7 days after onset	Self-reported history on bi-weekly questionnaire and confirmation by clinical staff.

Trial Locations

Locations (1)

Mbarara University of Science and Technology (MUST); 🇺🇬 Mbarara, Uganda