NCT05391230

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 400 (actual)
• Sponsor: University of North Carolina, Chapel Hill · Academic / Other
• Sex: All
• Age: 6 Months – 99 Years
• Healthy volunteers: Accepted

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.

Conditions

• Malaria
• P. Falciparum

Interventions

Type	Name	Description
OTHER	Permethrin-treated lesu	0.5% permethrin soaked baby wraps (lesus)
OTHER	Untreated lesu	Water soaked baby wraps (lesus)

Timeline

• Start date: 2022-06-03
• Primary completion: 2024-10-19
• Completion: 2024-11-30
• First posted: 2022-05-25
• Last updated: 2025-07-14

Locations

1 site across 1 country: Uganda