Malaria, P. Falciparum
Conditions
Keywords
Permethrin, Plasmodium Falciparum Infection, Insecticide, Malaria
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.
Interventions
0.5% permethrin soaked baby wraps (lesus)
OTHERUntreated lesu
Water soaked baby wraps (lesus)
Sponsors
Doris Duke Charitable Foundation
University of North Carolina, Chapel Hill
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Caregiver)
Masking description
Double
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.
Eligibility
Sex/Gender
ALL
Age
6 Months to 99 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 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). |
| Change in child's hemoglobin level | (Week 0), Week 12, and Week 24 visits | Change in child's hemoglobin as measured by HemoCue® device |
| 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 mother's hemoglobin level | (Week 0), Week 12, and Week 24 visits | Change in child's hemoglobin as measured by HemoCue® device |
| Adverse reaction to permethrin treatment | 7 days after onset | Self-reported history on bi-weekly questionnaire and confirmation by clinical staff. |
| Malaria hospitalization | 14 days after onset of symptoms | Child admitted to inpatient ward for treatment of malaria |
Countries
Uganda
Outcome results
None listed