Permethrin-treated Baby-wraps for the Prevention of Malaria in Children
IGHID 12128 - Getting Malaria "Off the Backs" of Women and Children in Western Uganda
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Mbarara, Uganda, PO Box 1410
- Mbarara University of Science and Technology (MUST)
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Intervention Arm : Arm that received 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).
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0.5% permethrin soaked baby wraps (lesus)
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Sham Comparator: Control Arm: Arm that received none permethrin-treated 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.
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Water soaked baby wraps (lesus)
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Incidence of clinical malaria in child
Time Frame: 7 days after onset of symptoms
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The presence of typical symptoms (e.g., fever, lethargy) and a positive malaria Rapid Diagnostic Test (RDT) during observation
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7 days after onset of symptoms
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Change in child's hemoglobin level
Time Frame: (Week 0), Week 12, and Week 24 visits
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Change in child's hemoglobin as measured by HemoCue® device
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(Week 0), Week 12, and Week 24 visits
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Change in child's growth parameters
Time Frame: (Week 0), Week 12, and Week 24 visits
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Change in child's height and weight (e.g., weight and height will be combined to report BMI in kg/m^2).
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(Week 0), Week 12, and Week 24 visits
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Change in child's nutritional status
Time Frame: (Week 0), Week 12, and Week 24 visits using MUAC tape
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Change in child's mid-upper arm circumference (MUAC)
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(Week 0), Week 12, and Week 24 visits using MUAC tape
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Prevalence of asymptomatic parasitemia
Time Frame: Every two weeks
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Presence of malaria parasites on bi-weekly dried blood spot (DBS) as determined by quantitative polymerase chain reaction(qPCR).
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Every two weeks
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Malaria hospitalization
Time Frame: 14 days after onset of symptoms
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Child admitted to inpatient ward for treatment of malaria
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14 days after onset of symptoms
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Incidence of clinical malaria in mother
Time Frame: 7 days after onset of symptoms
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The presence of typical symptoms (e.g., fever, lethargy) and a positive malaria RDT during observation
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7 days after onset of symptoms
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Change in mother's hemoglobin level
Time Frame: (Week 0), Week 12, and Week 24 visits
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Change in child's hemoglobin as measured by HemoCue® device
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(Week 0), Week 12, and Week 24 visits
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Adverse reaction to permethrin treatment
Time Frame: 7 days after onset
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Self-reported history on bi-weekly questionnaire and confirmation by clinical staff.
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7 days after onset
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Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Ross Boyce, MD, MSc, University of North Carolina, Chapel Hill
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 21-2569
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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