Trials Sponsors Conditions Drugs Pricing

Conditions

Malaria (Plasmodium Falciparum)Malaria Incidence

Keywords

LesuMalariaPermethrin

Outcome Measures

Primary Outcomes (1)

Incidence of clinical malaria in children
Acute febrile illness defined as fever (temperature ≥38.0 Celsius) or fever reported in past 24 hours AND positive malaria rapid diagnostic test (RDT), confirmed by light microscopy (performed later), at scheduled or unscheduled study clinic visit
From enrollment to Month 6

Secondary Outcomes (34)

Incidence of hospitalizations due to malaria
From enrollment to Month 6
Incidence of hospitalizations due to any cause
From enrollment to Month 6
Number of deaths due to any cause
From enrollment to Month 6
Number of deaths due to malaria
From enrollment to Month 6
Incidence of non-malarial febrile episodes in children
From enrollment to Month 6
+29 more secondary outcomes

Study Arms (3)

Receives factory-treated permethrin lesu

EXPERIMENTAL

Receives factory-treated (0.52%) permethrin-treated wrap for 6 months

Other: Factory-treated lesu

Receives soaked permethrin lesu

EXPERIMENTAL

Receives soaked (1%) permethrin-treated wrap for 6 months

Other: Soaked lesu

Receives untreated lesu

SHAM COMPARATOR

Receives the untreated lesu for 6 months

Other: Untreated lesu

Interventions

Factory-treated lesuOther

Patterned cotton-blend fabric will be obtained and treated with 0.52% permethrin at Perimeter Insect Guard. After treatment, the material will be cut into 2 x 1 meter swathes

Receives factory-treated permethrin lesu

Soaked lesuOther

Wraps will be soaked in 1.0% permethrin solution donated by Sawyer Products (Safety Harbor, FL) in accordance with the manufacturer's instructions and allowed to dry. The material will be cut into 2 x 1 meter swathes

Eligibility Criteria

Age3 Months - 99 Years

Sexall(Gender-based eligibility)

Gender Eligibility DetailsFemale with infants between the ages of 3-18 months at time of enrollment

Healthy VolunteersYes

Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

Mother is at least 18 years old

Sponsors & Collaborators

Mbarara University of Science and Technology
Othercollaborator
University of North Carolina, Chapel Hill
Otherlead

Study Sites (1)

Mbarara University of Science and Technology

Mbarara, Uganda

Edgar Mulogo, PhD, MPHCONTACT256-48540-20332

Edgar Mulogo, PhD, MPHPRINCIPAL INVESTIGATOR

MeSH Terms

Conditions

Malaria, FalciparumMalaria

Condition Hierarchy (Ancestors)

Protozoan InfectionsParasitic DiseasesInfectionsMosquito-Borne DiseasesVector Borne Diseases

Study Officials

Ross Boyce, MD, MSc
University of North Carolina, Chapel Hill
PRINCIPAL INVESTIGATOR

Central Study Contacts

Ross Boyce, MD, MSc

CONTACT

919-966-2537 ross_boyce@med.unc.edu

Study Design

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

Study Record Dates

First Submitted

October 21, 2026

First Posted

October 29, 2026

Study Start

September 1, 2027

Estimated

Planned date reported by the registry; this milestone is not confirmed as achieved.

Primary Completion

September 1, 2029

Permethrin-Treated Baby Wraps for Malaria Prevention in Refugee Settings

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (34)

Study Arms (3)

Receives factory-treated permethrin lesu

Receives soaked permethrin lesu

Receives untreated lesu

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (34)

Study Arms (3)

Receives factory-treated permethrin lesu

Receives soaked permethrin lesu

Receives untreated lesu

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations