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

NCT05391230 | Completed

• 1 other identifier: 21-2569
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

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.

Conditions

Malaria; P. Falciparum

Keywords

Permethrin; Plasmodium Falciparum Infection; Insecticide; Malaria

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Change in child's hemoglobin level

  (Week 0), Week 12, and Week 24 visits

• Change in child's growth parameters

  (Week 0), Week 12, and Week 24 visits

• Change in child's nutritional status

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

• Prevalence of asymptomatic parasitemia

  Every two weeks

• Malaria hospitalization

  14 days after onset of symptoms

Study Arms (2)

Intervention Arm : Arm that received permethrin-treated lesu

EXPERIMENTAL

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).

Other: Permethrin-treated lesu

Control Arm: Arm that received none permethrin-treated lesu

SHAM COMPARATOR

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.

Other: Untreated lesu

Interventions

Permethrin-treated lesu OTHER

0.5% permethrin soaked baby wraps (lesus)

Intervention Arm : Arm that received permethrin-treated lesu

Untreated lesu OTHER

Water soaked baby wraps (lesus)

Control Arm: Arm that received none permethrin-treated lesu

Eligibility Criteria

• Age: 6 Months - 99 Years
• Gender Eligibility Details: Female with infants between the ages of 6 months to 18 months at time of enrollment
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• Doris Duke Charitable Foundation: collaborator

Study Sites (1)

Mbarara University of Science and Technology (MUST)

Mbarara, PO Box 1410, Uganda

Location

Related Publications (2)

• Boyce RM, Shook-Sa BE, Ndizeye R, Baguma E, Giandomenico D, Cassidy CA, Eshun S, Siedner MJ, Staedke SG, Ntaro M, Juliano JJ, Reyes R, Mulogo EM. Permethrin-Treated Baby Wraps for the Prevention of Malaria. N Engl J Med. 2025 Oct 9;393(14):1399-1408. doi: 10.1056/NEJMoa2501628. Epub 2025 Sep 24.

  PMID: 40991921 DERIVED

• Boyce RM, Cassidy C, Ndizeye R, Baguma E, Giandomenico D, Shook-Sa BE, Ntaro M, Reyes R, Mulogo EM. Permethrin-treated baby wraps for the prevention of malaria in children: Protocol for a double-blind, randomized placebo-controlled controlled trial in western Uganda. PLoS One. 2023 Apr 27;18(4):e0284322. doi: 10.1371/journal.pone.0284322. eCollection 2023.

  PMID: 37104305 DERIVED

Related Links

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

MeSH Terms

Conditions

Malaria

Condition Hierarchy (Ancestors)

Protozoan Infections; Parasitic Diseases; Infections; Mosquito-Borne Diseases; Vector Borne Diseases

Study Officials

• Ross Boyce, MD, Msc

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: Double
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: May 20, 2022
• First Posted: May 25, 2022
• Study Start: June 3, 2022
• Primary Completion: October 19, 2024
• Study Completion: November 30, 2024
• Last Updated: July 14, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Time Frame: beginning 9 and continuing through 36 months following publication
• Access Criteria: Requesting investigator has approved IRB, IEC, or REB and an executed data use/sharing agreement with UNC.

Locations

UG (1)