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

Malaria Clinical Trial

Official title:

IGHID 12128 - Getting Malaria "Off the Backs" of Women and Children in Western Uganda

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05391230
• Other study ID #: 21-2569
• Status: Recruiting
• Phase: N/A
• Start date: June 3, 2022
• Est. completion date: June 2025

Study information

• Verified date: November 2023
• Source: University of North Carolina, Chapel Hill
• Contact: Ross Royce, MD, Msc
• Phone: +1 (919) 966-2537
• Email: ross_boyce[@]med.unc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: June 2025
• Est. primary completion date: June 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Months to 99 Years

Eligibility

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.

Related Conditions & MeSH terms

• Malaria
• P. Falciparum

Intervention

Other:
• Permethrin-treated lesu
0.5% permethrin soaked baby wraps (lesus)
• Untreated lesu
Water soaked baby wraps (lesus)

Locations

Country	Name	City	State
Uganda	Mbarara University of Science and Technology (MUST)	Mbarara

Sponsors (2)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill	Doris Duke Charitable Foundation

Country where clinical trial is conducted

Uganda, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	7 days after onset of symptoms
Secondary	Change in child's hemoglobin level	Change in child's hemoglobin as measured by HemoCue® device	(Week 0), Week 12, and Week 24 visits
Secondary	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).	(Week 0), Week 12, and Week 24 visits
Secondary	Change in child's nutritional status	Change in child's mid-upper arm circumference (MUAC)	(Week 0), Week 12, and Week 24 visits using MUAC tape
Secondary	Prevalence of asymptomatic parasitemia	Presence of malaria parasites on bi-weekly dried blood spot (DBS) as determined by quantitative polymerase chain reaction(qPCR).	Every two weeks
Secondary	Malaria hospitalization	Child admitted to inpatient ward for treatment of malaria	14 days after onset of symptoms
Secondary	Incidence of clinical malaria in mother	The presence of typical symptoms (e.g., fever, lethargy) and a positive malaria RDT during observation	7 days after onset of symptoms
Secondary	Change in mother's hemoglobin level	Change in child's hemoglobin as measured by HemoCue® device	(Week 0), Week 12, and Week 24 visits
Secondary	Adverse reaction to permethrin treatment	Self-reported history on bi-weekly questionnaire and confirmation by clinical staff.	7 days after onset

External Links

•   Permethrin-treated baby wraps for the prevention of malaria: results of a randomized controlled pilot study in rural Uganda