An interventional study of Factory-treated lesu and Soaked lesu in Malaria (Plasmodium Falciparum) and Malaria Incidence, sponsored by University of North Carolina, Chapel Hill. Not yet recruiting at 1 site in Uganda. Open to participants aged 3 Months to 99 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-29.
Sponsored by University of North Carolina, Chapel Hill · Not applicable, Interventional, and Prevention
The objective is to test the protective effect of permethrin-treated lesus against malaria in young children in refugee settings
The proposed study is a randomized, double-blind trial of factory-treated, long-lasting permethrin vs. soaked permethrin vs. sham-treated (control) wraps for the prevention of malaria in young children among newly arrived refugees. 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 675 mother-infant pairs with 225 pairs in each group. The investigators will follow participants longitudinally for 6 months. Participants will be instructed and incentivized to present to one of the study clinics when a fever develops, where they will be evaluated, tested, and treated, if positive, for malaria. Participants will also be followed monthly for routine surveillance.
455 studies on the registry are indexed under Malaria, Falciparum; 37 are open to participants now.
This study's planned enrollment of 1,350 is above the median of 126 across 376 interventional studies indexed under Malaria, Falciparum.
Browse Malaria, Falciparum studies →University of North Carolina, Chapel Hill is the lead sponsor of 1,372 studies on the registry; 133 are open to participants now.
Of its 161 completed or terminated interventional studies of FDA-regulated products, 139 (86%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Receives factory-treated (0.52%) permethrin-treated wrap for 6 months
Other: Factory-treated lesu
Receives soaked (1%) permethrin-treated wrap for 6 months
Other: Soaked lesu
Receives the untreated lesu for 6 months
Other: Untreated lesu
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
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
Untreated fabric of identical appearance (i.e., color and pattern) will be similarly cut and packaged for use
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
Time frame: From enrollment to Month 6
Incidence of hospitalizations due to malaria
Incidence of admissions from clinic after a positive malaria RDT
Time frame: From enrollment to Month 6
Incidence of hospitalizations due to any cause
Incidence of admissions from clinic after a positive malaria RDT
Time frame: From enrollment to Month 6
Number of deaths due to any cause
Incidence of admissions from clinic after a positive malaria RDT
Time frame: From enrollment to Month 6
Number of deaths due to malaria
Incidence of admissions from clinic after a positive malaria RDT
Time frame: From enrollment to Month 6
Incidence of non-malarial febrile episodes in children
Incidence of participants experiencing acute febrile illness and negative malaria RDT at a scheduled or unscheduled study visit.
Time frame: From enrollment to Month 6
Wrap attrition
The number of wraps lost or damaged and requiring replacement.
Time frame: From enrollment to Month 6
Off-target use of wraps
Self-reported use for other purposes or use with other household members
Time frame: From enrollment to Month 6
Incidence of malaria among mothers or other children (age < 5) in the household
Acute febrile illness defined as fever (temperature ≥38.0 Celsius) or fever reported in past 24 hours AND positive malaria rapid diagnostic test (RDT) at scheduled or unscheduled study clinic visit
Time frame: From enrollment to Month 6
Perception of intervention
The median scores of the first 4 Likert-scale questions on the interview (e.g. Overall Experience). Higher scores indicate a more positive perception.
Time frame: Month 6
Number of adverse reactions to wraps
Counts of the top 5 most common adverse reactions reported by participants on questionnaires and assessed by clinic staff.
Time frame: From enrollment to Month 6
Number of participants with care-seeking events attributable to the wrap
Number of participants with care-seeking events attributable to the wrap.
Time frame: From enrollment to Month 6
Number of participants with hospitalizations attributable to the wrap
Number of participants with hospitalizations attributable to the wrap
Time frame: From enrollment to Month 6
Number of participants with death attributable to the wrap
Number of participants with death attributable to the wrap
Time frame: From enrollment to Month 6
Change in child's height-for-weight
Change in Z-score for height-for-weight. A height-for-weight Z-score indicates how a child's height compares with a reference population of children of the same weight. A score of 0 represents the reference average; positive values indicate above-average height-for-weight, and negative values indicate below-average height-for-weight. Z = 0: Average height-for-weight in the reference population Z = +1: One standard deviation above the reference average Z = -1: One standard deviation below the reference average Z = -2: Substantially below the reference average
Time frame: Enrollment, Month 3, Month 6
Change in child's height-for-age
Change in Z-score for height-for-age. A height-for-age Z-score indicates how a child's height compares with a reference population of children of the same age. A score of 0 represents the reference average; positive values indicate above-average height-for-age, and negative values indicate below-average height-for-age. Z = 0: Average height-for-age in the reference population Z = +1: One standard deviation above the reference average Z = -1: One standard deviation below the reference average Z = -2: Substantially below the reference average
Time frame: Enrollment, Month 3, Month 6
Change in child's weight-for-age
Change in Z-score for weight-for-age. Change in Z-score for weight-for-age. A weight-for-age Z-score indicates how a child's weight compares with a reference population of children of the same age. A score of 0 represents the reference average; positive values indicate above-average weight-for-age, and negative values indicate below-average weight-for-age. Z = 0: Average weight-for-age in the reference population Z = +1: One standard deviation above the reference average Z = -1: One standard deviation below the reference average Z = -2: Substantially below the reference average
Time frame: Enrollment, Month 3, Month 6
Change in child's acute malnutrition
Change in Mid-upper arm circumference (MUAC).
Time frame: From enrollment to Month 6
Change in child's median score on the Mullen Scales of Early Learning
Change in median composite scores on the Mullen Scales of Early Learning. The Early Learning Composite from the Mullen Scales of Early Learning (MSEL) will be used to measure developmental functioning. The Early Learning Composite (ELC) is a standardized composite score derived from the 5 subtests measured on the MSEL. It has a mean of 100 and a standard deviation of 15. Higher scores indicate stronger performance.
Time frame: From enrollment to Month 6
Change in child's mean score on the Mullen Scales of Early Learning
Change in mean composite scores on the Mullen Scales of Early Learning. The Early Learning Composite from the Mullen Scales of Early Learning (MSEL) will be used to measure developmental functioning. The Early Learning Composite (ELC) is a standardized composite score derived from the 5 subtests measured on the MSEL. It has a mean of 100 and a standard deviation of 15. Higher scores indicate stronger performance.
Time frame: From enrollment to Month 6
Change in child's percentile on the Developmental Profile 4: Physical Scale
Performance on the Physical subscale of the Developmental Profile 4, which includes items measuring gross- and fine-motor skills, coordination, strength, stamina, and flexibility. Expressed as a percentile from 0 to 100%, where a score of 50% indicates that the child performs equal to their same age peers, a score above 50% indicates they perform better than their same age peers, and a score below 50% indicates they perform worse than their same age peers.
Time frame: From enrollment to Month 6
Change in child's percentile on the Developmental Profile 4: Adaptive Behavior Scale
Performance on the Adaptive Behavior subscale of the Developmental Profile 4, which includes items measuring age-appropriate independent functioning. Expressed as a percentile from 0 to 100%, where a score of 50% indicates that the child performs equal to their same age peers, a score above 50% indicates they perform better than their same age peers, and a score below 50% indicates they perform worse than their same age peers.
Time frame: From enrollment to Month 6
Change in child's percentile on the Developmental Profile 4: Social-Emotional Scale
Performance on the Social-Emotional subscale of the Developmental Profile 4, which includes items measuring skills related to interpersonal behavior and demonstration of social and emotional competence. Expressed as a percentile from 0 to 100%, where a score of 50% indicates that the child performs equal to their same age peers, a score above 50% indicates they perform better than their same age peers, and a score below 50% indicates they perform worse than their same age peers.
Time frame: From enrollment to Month 6
Change in child's percentile on the Developmental Profile 4: Cognitive Scale
Performance on the Cognitive subscale of the Developmental Profile 4, which includes items measuring perception, concept development, number relations, reasoning, memory, classification, time concepts, and related mental acuity tasks. Expressed as a percentile from 0 to 100%, where a score of 50% indicates that the child performs equal to their same age peers, a score above 50% indicates they perform better than their same age peers, and a score below 50% indicates they perform worse than their same age peers
Time frame: From enrollment to Month 6
Change in child's percentile on the Developmental Profile 4: Communication Scale
Performance on the Communication subscale of the Developmental Profile 4, which reflects the ability to understand spoken and written language as well as to use both verbal and nonverbal skills to communicate. Expressed as a percentile from 0 to 100%, where a score of 50% indicates that the child performs equal to their same age peers, a score above 50% indicates they perform better than their same age peers, and a score below 50% indicates they perform worse than their same age peers.
Time frame: From enrollment to Month 6
Change in child's growth score on the Developmental Profile 4: Physical Scale
Performance on the Physical subscale of the Developmental Profile 4, which is expressed as a a raw score from 40 to 160 that is designed specifically to track progress and monitor developmental change over time, where higher scores indicate better performance
Time frame: From enrollment to Month 6
Change in child's growth score on the Developmental Profile 4: Adaptive Behavior Scale
Performance on the Adaptive Behavior subscale of the Developmental Profile 4, which is expressed as a a raw score from 40 to 160 that is designed specifically to track progress and monitor developmental change over time, where higher scores indicate better performance
Time frame: From enrollment to Month 6
Change in child's growth score on the Developmental Profile 4: Social-Emotional Scale
Performance on the Social-Emotional subscale of the Developmental Profile 4, which is expressed as a a raw score from 40 to 160 that is designed specifically to track progress and monitor developmental change over time, where higher scores indicate better performance
Time frame: From enrollment to Month 6
Change in child's growth score on the Developmental Profile 4: Cognitive Scale
Performance on the Cognitive subscale of the Developmental Profile 4, which is expressed as a a raw score from 40 to 160 that is designed specifically to track progress and monitor developmental change over time, where higher scores indicate better performance
Time frame: From enrollment to Month 6
Change in child's growth score on the Developmental Profile 4: Communication Scale
Performance on the Communication subscale of the Developmental Profile 4, which is expressed as a a raw score from 40 to 160 that is designed specifically to track progress and monitor developmental change over time, where higher scores indicate better performance
Time frame: From enrollment to Month 6
Change in child's age equivalent on the Developmental Profile 4: Physical Scale
Performance on the Physical subscale of the Developmental Profile 4, which translates the child's performance to the age at which an average child achieves those same raw scores. Expressed as a metric in the format X:Y where X equals the number of years old, and Y equals a number between 0 and 11. Values higher than the child's age-equivalence reflects developmental functioning consistent with that of older children
Time frame: From enrollment to Month 6
Change in child's age equivalent on the Developmental Profile 4: Adaptive Behavior Scale
Performance on the Adaptive Behavior subscale of the Developmental Profile 4, which translates the child's performance to the age at which an average child achieves those same raw scores. Expressed as a metric in the format X:Y where X equals the number of years old, and Y equals a number between 0 and 11. Values higher than the child's age-equivalence reflects developmental functioning consistent with that of older children
Time frame: From enrollment to Month 6
Change in child's age equivalent on the Developmental Profile 4: Social-Emotional Scale
Performance on the Social-Emotional subscale of the Developmental Profile 4, which translates the child's performance to the age at which an average child achieves those same raw scores. Expressed as a metric in the format X:Y where X equals the number of years old, and Y equals a number between 0 and 11. Values higher than the child's age-equivalence reflects developmental functioning consistent with that of older children.
Time frame: From enrollment to Month 6
Change in child's age equivalent on the Developmental Profile 4: Cognitive Scale
Performance on the Cognitive subscale of the Developmental Profile 4, which translates the child's performance to the age at which an average child achieves those same raw scores. Expressed as a metric in the format X:Y where X equals the number of years old, and Y equals a number between 0 and 11. Values higher than the child's age-equivalence reflects developmental functioning consistent with that of older children
Time frame: From enrollment to Month 6
Change in child's age equivalent on the Developmental Profile 4: Communication Scale
Performance on the Communication subscale of the Developmental Profile 4, which translates the child's performance to the age at which an average child achieves those same raw scores. Expressed as a metric in the format X:Y where X equals the number of years old, and Y equals a number between 0 and 11. Values higher than the child's age-equivalence reflects developmental functioning consistent with that of older children.
Time frame: From enrollment to Month 6
Plan to share: Yes — Deidentified individual data that supports the results may be shared beginning 9 and continuing for 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.
Time frame: beginning 9 and continuing for 36 months following publication
Access criteria: Investigator has approved IRB, IEC, or REB and an executed data use/sharing agreement with UNC.
No publications or documents are linked to this record.
Start is estimated for Sep 2027; primary completion for Sep 2029, 24 months later.
Of 24 interventional studies with no phase under Malaria, Falciparum, half reached primary completion within 20 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 31. This study's planned 24 months is above that.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
University of North Carolina, Chapel Hill →