MalariaNCT05391230
Permethrin-treated Baby-wraps for the Prevention of Malaria in Children
A study testing Permethrin-treated lesu and Untreated lesu in people with Malaria and P. Falciparum, run by University of North Carolina, Chapel Hill at 1 site in Uganda.
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. Read more about this study
- Who is it for?
- Ages 6 months to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Malaria, P. Falciparum
- What is being tested?
- Permethrin-treated lesu and Untreated lesu
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 400 participants
- Where
- 1 siteUganda
- Study dates
- 3 Jun 2022to 30 Nov 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 months to 99 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Uganda1 site
Mbarara University of Science and Technology (MUST)
Mbarara, PO Box 1410
About this study
Official title: IGHID 12128 - Getting Malaria "Off the Backs" of Women and Children in Western Uganda
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.
Read the 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
- Being tested
- Permethrin-treated lesu, Untreated lesu
- Keywords
- Permethrin, Plasmodium Falciparum Infection, Insecticide, Malaria
- Medical subject headings
- Malaria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Permethrin-treated lesuOther
0.5% permethrin soaked baby wraps (lesus)
Untreated lesuOther
Water soaked baby wraps (lesus)
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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. Receives: Other: Untreated lesu |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 7 days after onset of symptoms
Secondary outcomes (8)
Change in child's hemoglobin level
Change in child's hemoglobin as measured by HemoCue® device
Measured: (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).
Measured: (Week 0), Week 12, and Week 24 visits
Change in child's nutritional status
Change in child's mid-upper arm circumference (MUAC)
Measured: (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).
Measured: Every two weeks
Malaria hospitalization
Child admitted to inpatient ward for treatment of malaria
Measured: 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
Measured: 7 days after onset of symptoms
Change in mother's hemoglobin level
Change in child's hemoglobin as measured by HemoCue® device
Measured: (Week 0), Week 12, and Week 24 visits
Adverse reaction to permethrin treatment
Self-reported history on bi-weekly questionnaire and confirmation by clinical staff.
Measured: 7 days after onset
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2022
- Study start3 Jun 2022
- Primary completion19 Oct 2024
- Study completion30 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for MalariaStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- Doris Duke Charitable Foundation
- Responsible party
- Sponsor
- Investigators
- Ross Boyce, MD, Msc, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05391230
- Sponsor's protocol ID
- 21-2569
- Status last verified
- Jul 2025
- First submitted
- 20 May 2022
- Last updated
- 14 Jul 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.
Publications
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.
PubMed 40991921Boyce 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.
PubMed 37104305
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- IGHID 12128 - Getting Malaria "Off the Backs" of Women and Children in Western Uganda
- ClinicalTrials.gov ID
- NCT05391230
- Acronym / sponsor ID
- 21-2569
- Conditions
- Malaria, P. Falciparum
- Keywords
- Permethrin, Plasmodium Falciparum Infection, Insecticide, Malaria
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- Doris Duke Charitable Foundation
- Study start
- 3 Jun 2022 (actual)
- Primary completion
- 19 Oct 2024 (actual)
- Study completion
- 30 Nov 2024 (actual)
- First posted
- 25 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Intervention Arm : Arm that received permethrin-treated lesu | Experimental | Other: Permethrin-treated lesuIntervention 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). |
| Control Arm: Arm that received none permethrin-treated lesu | Sham comparator | Other: Untreated lesuThe 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. |
Who may qualify
- Ages
- 6 months to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Permethrin-treated lesu0.5% permethrin soaked baby wraps (lesus) | Other | Intervention Arm : Arm that received permethrin-treated lesu |
| Untreated lesuWater soaked baby wraps (lesus) | Other | Control Arm: Arm that received none permethrin-treated lesu |
Primary outcome
Incidence of clinical malaria in child
Time frame: 7 days after onset of symptoms
The presence of typical symptoms (e.g., fever, lethargy) and a positive malaria Rapid Diagnostic Test (RDT) during observation
8 secondary outcomes
Change in child's hemoglobin level
Time frame: (Week 0), Week 12, and Week 24 visits
Change in child's growth parameters
Time frame: (Week 0), Week 12, and Week 24 visits
Change in child's nutritional status
Time frame: (Week 0), Week 12, and Week 24 visits using MUAC tape
Prevalence of asymptomatic parasitemia
Time frame: Every two weeks
Malaria hospitalization
Time frame: 14 days after onset of symptoms
Incidence of clinical malaria in mother
Time frame: 7 days after onset of symptoms
Change in mother's hemoglobin level
Time frame: (Week 0), Week 12, and Week 24 visits
Adverse reaction to permethrin treatment
Time frame: 7 days after onset
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2025.
- Derived from this study: PubMed 40991921Boyce 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.
- Derived from this study: PubMed 37104305Boyce 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.
- Permethrin-treated baby wraps for the prevention of malaria: results of a randomized controlled pilot study in rural UgandaLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ross Boyce, MD, Msc principal investigator
University of North Carolina, Chapel Hill
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Permethrin-treated lesu and Untreated lesu in people with Malaria and P. Falciparum, run by University of North Carolina, Chapel Hill at 1 site in Uganda.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Uganda. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of clinical malaria in child (time frame: 7 days after onset of symptoms). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05391230, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2025.