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

University of North Carolina, Chapel Hill400 enrolled

Overview

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.

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

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

400

Conditions

Malaria P. Falciparum

Interventions

Permethrin-treated lesuOTHER

0.5% permethrin soaked baby wraps (lesus)

Untreated lesuOTHER

Water soaked baby wraps (lesus)

Eligibility

Sex: ALLMin age: 6 MonthsMax age: 99 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Mbarara University of Science and Technology (MUST)

Mbarara, Uganda

Outcomes

Primary Outcomes

Incidence of clinical malaria in child

The presence of typical symptoms (e.g., fever, lethargy) and a positive malaria Rapid Diagnostic Test (RDT) during observation

Time frame: 7 days after onset of symptoms

Secondary Outcomes

Change in child's hemoglobin level

Change in child's hemoglobin as measured by HemoCue® device

Time frame: (Week 0), Week 12, and Week 24 visits

Change in child's growth parameters

Change in child's height and weight (e.g., weight and height will be combined to report BMI in kg/m\^2).

Time frame: (Week 0), Week 12, and Week 24 visits

Change in child's nutritional status

Change in child's mid-upper arm circumference (MUAC)

Time frame: (Week 0), Week 12, and Week 24 visits using MUAC tape

Prevalence of asymptomatic parasitemia

Presence of malaria parasites on bi-weekly dried blood spot (DBS) as determined by quantitative polymerase chain reaction(qPCR).

Time frame: Every two weeks

Malaria hospitalization

Child admitted to inpatient ward for treatment of malaria

Time frame: 14 days after onset of symptoms

Incidence of clinical malaria in mother

The presence of typical symptoms (e.g., fever, lethargy) and a positive malaria RDT during observation

Time frame: 7 days after onset of symptoms

Data from ClinicalTrials.gov

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