Malaria (Plasmodium Falciparum)NCT07773350
Insecticide-Treated Baby Wraps for the Prevention of Malaria
A study testing Permethrin-treated lesu, Etofenprox-treated lesu and Untreated lesu in people with Malaria (Plasmodium Falciparum) and Malaria Incidence, run by University of North Carolina, Chapel Hill at 1 site in Uganda.
Trial summary
The objective is to test the protective effect of permethrin-treated and etofenprox-treated lesus against malaria in young children Read more about this study
- Who is it for?
- Ages 2 months to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Malaria (Plasmodium Falciparum), Malaria Incidence
- What is being tested?
- Permethrin-treated lesu, Etofenprox-treated lesu and Untreated lesu
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,296 participants
- Where
- 1 siteUganda
- Study dates
- 1 Jan 2027to 1 Jan 2031
- Phase
- Interventional
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 2 months to 99 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Mother is at least 18 years old
- Mother has access to a working phone with a known number
- Mother is the parent or legal guardian of a singleton (i.e., not a twin) infant 2-4 months of age
- Has the ability to travel to a designated study site for visits and evaluation
- Mother/Infant pair presents to their 10-week immunization visit at one of the designated study sites
Who cannot join
- Participation in another study of malaria prevention
- Known allergic reaction to permethrin or etofenprox
- Infant has a known HIV diagnosis (or exposure) or sickle cell disease that would be an indication for malaria prophylaxis
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Uganda1 site
Mbarara University of Science and Technology
Mbarara
Edgar Mulogo, PhD, MPH, 256-48540-20332
Edgar Mulogo, PhD, MPH
About this study
Official title: Factory-Treated, Long-Lasting Insecticide-Treated Baby Wraps for the Prevention of Malaria: A Phase III Clinical Trial
The objective is to test the protective effect of permethrin-treated and etofenprox-treated lesus against malaria in young children
Read the detailed description
The proposed study is a double-blind, randomized control trial of permethrin-treated and etofenprox-treated lesus to prevent P. falciparum malaria in children 2-4 months of age conducted at three sites in rural 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 1,296 mother-infant pairs with 144 pairs in each group. The investigators will follow participants longitudinally for three years. 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 attend scheduled clinic visits every two months for routine surveillance of adverse effects and to test for asymptomatic infection. Re-treatment and sham re-treatment of lesus will occur after 1 year of participation. Participants will be asked to return the lesus after 2 years of participation.
- Conditions
- Malaria (Plasmodium Falciparum), Malaria Incidence
- Being tested
- Permethrin-treated lesu, Etofenprox-treated lesu, Untreated lesu
- Keywords
- Lesu, Malaria, Permethrin, Etofenprox
- Medical subject headings
- Malaria, Falciparum, Malaria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Permethrin-treated lesuOther
Patterned cotton-blend fabric will be obtained and treated with permethrin at Perimeter Insect Guard. After treatment, the material will be cut into 2 x 1 meter swathes
Etofenprox-treated lesuOther
Patterned cotton-blend fabric will be obtained and treated with etofenprox at Perimeter Insect Guard. After treatment, the material will be cut into 2 x 1 meter swathes
Untreated lesuOther
Untreated fabric of identical appearance (i.e., color and pattern) will be similarly cut and packaged for use
| Study group | Role | What they receive |
|---|---|---|
| Receives permethrin-treated lesu | Experimental | Receives permethrin-treated lesu for 2 years Receives: Other: Permethrin-treated lesu |
| Receives etofenprox-treated lesu | Experimental | Receives etofenprox-treated lesu for 2 years Receives: Other: Etofenprox-treated lesu |
| Receives non-treated lesu | Sham comparator | Receives the non-treated lesu for 2 years 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 children between the etofenprox and control arms
Incidence of participants experiencing acute febrile illness AND positive malaria rapid diagnostic test (RDT) at a scheduled or unscheduled study visit.
Measured: From enrollment through Month 24
Incidence of clinical malaria in children between the permethrin and control arms
Incidence of participants experiencing acute febrile illness AND positive malaria RDT at a scheduled or unscheduled study visit.
Measured: From enrollment through Month 24
Secondary outcomes (67)
Incidence of clinical malaria in children between the permethrin and control arms per site
Incidence of participants experiencing acute febrile illness AND positive malaria RDT at a scheduled or unscheduled study visit.
Measured: From enrollment through Month 24
Incidence of clinical malaria in children between the etofenprox and control arms per site
Incidence of participants experiencing acute febrile illness AND positive malaria RDT at a scheduled or unscheduled study visit.
Measured: From enrollment through Month 24
Incidence of hospitalizations due to malaria between the permethrin and control arms
Incidence of admissions from clinic after a positive malaria RDT.
Measured: From enrollment to Month 36
Incidence of hospitalizations due to malaria between the etofenprox and control arms
Incidence of admissions from clinic after a positive malaria RDT.
Measured: From enrollment to Month 36
Number of deaths from any cause between the permethrin and control arms during wrap use
Number of deaths documented, regardless of cause.
Measured: From enrollment to Month 24
Number of deaths from any cause between the etofenprox and control arms during wrap use
Number of deaths documented, regardless of cause.
Measured: From enrollment to Month 24
Number of deaths from any cause between the permethrin and control arms after wrap use has been discontinued
Number of deaths documented, regardless of cause.
Measured: From Month 24 to Month 36
Number of deaths from any cause between the etofenprox and control arms after wrap use has been discontinued
Number of deaths documented, regardless of cause.
Measured: From Month 24 to Month 36
Number of deaths from malaria between the permethrin and control arms during wrap use
Number of deaths documented during hospitalization.
Measured: From enrollment to Month 24
Number of deaths from malaria between the etofenprox and control arms during wrap use
Number of deaths documented during hospitalization.
Measured: From enrollment to Month 24
Number of deaths from malaria between the permethrin and control arms after wrap use has been discontinued
Number of deaths documented during hospitalization.
Measured: From Month 24 to Month 36
Number of deaths from malaria between the etofenprox and control arms after wrap use has been discontinued
Number of deaths documented during hospitalization.
Measured: From Month 24 to Month 36
Difference between the permethrin and control arms in change from baseline of childrens' hemoglobin levels
Hemoglobin measured using a Hemocue device.
Measured: At baseline, 12 Months, and 24 Months
Difference between the etofenprox and control arms in change from baseline of childrens' hemoglobin levels
Hemoglobin measured using a Hemocue device.
Measured: At baseline, 12 Months, and 24 Months
Incidence of non-malarial febrile episodes in children between the permethrin and control arms
Incidence of participants experiencing acute febrile illness and negative malaria RDT at a scheduled or unscheduled study visit.
Measured: From enrollment through Month 24
Incidence of non-malarial febrile episodes in children between the etofenprox and control arms
Incidence of participants experiencing acute febrile illness and negative malaria RDT at a scheduled or unscheduled study visit.
Measured: From enrollment through Month 24
Wrap attrition
The number of wraps lost or damaged and requiring replacement.
Measured: From enrollment through Month 24
Incidence of rebound clinical malaria in children between the permethrin and control arms
Incidence of participants experiencing acute febrile illness AND positive malaria RDT at a scheduled or unscheduled study visit after wrap discontinuation.
Measured: From Month 24 through Month 36
Incidence of rebound clinical malaria in children between the etofenprox and control arms
Incidence of participants experiencing acute febrile illness AND positive malaria RDT at a scheduled or unscheduled study visit after wrap discontinuation.
Measured: From Month 24 through Month 36
Number of adverse reactions to wraps between the permethrin and control arms
Counts of the top 5 most common adverse reactions reported by participants on questionnaires and assessed by clinic staff.
Measured: From enrollment through Month 24
Number of adverse reactions to wraps between the etofenprox and control arms
Counts of the top 5 most common adverse reactions reported by participants on questionnaires and assessed by clinic staff.
Measured: From enrollment through Month 24
Number of participants with care-seeking events attributable to the permethrin wrap versus the control
Number of participants with care-seeking events attributable to the permethrin wrap versus the control wrap.
Measured: From enrollment through Month 24
Number of participants with care-seeking events attributable to the etofenprox wrap versus the control
Number of participants with care-seeking events attributable to the etofenprox wrap versus the control wrap.
Measured: From enrollment through Month 24
Number of participants with hospitalizations attributable to the permethrin wrap versus the control
Number of participants with hospitalizations attributable to the permethrin wrap versus the control wrap.
Measured: From enrollment through Month 24
Number of participants with hospitalizations attributable to the etofenprox wrap versus the control
Number of participants with hospitalizations attributable to the etofenprox wrap versus the control wrap.
Measured: From enrollment through Month 24
Number of participants with death attributable to the permethrin wrap versus the control
Number of participants with death attributable to the permethrin wrap versus the control wrap.
Measured: From enrollment through Month 24
Number of participants with death attributable to the etofenprox wrap versus the control
Number of participants with death attributable to the etofenprox wrap versus the control wrap.
Measured: From enrollment through Month 24
Change in child's height-for-weight between the permethrin and control arms
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
Measured: From enrollment through Month 24
Change in child's height-for-weight between the etofenprox and control arms
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 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
Measured: From enrollment through Month 24
Change in child's height-for-age between the permethrin and control arms
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
Measured: From enrollment through Month 24
Change in child's height-for-age between the etofenprox and control arms
Change in Z-score for 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
Measured: From enrollment through Month 24
Change in child's weight-for-age between the permethrin and control arms
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
Measured: From enrollment through Month 24
Change in child's weight-for-age between the etofenprox and control arms
Change in Z-score for 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
Measured: From enrollment through Month 24
Change in child's acute malnutrition between the permethrin and control arms
Change in Mid-upper arm circumference (MUAC).
Measured: From enrollment through Month 24
Change in child's acute malnutrition between the etofenprox and control arms
Change in Mid-upper arm circumference (MUAC).
Measured: From enrollment through Month 24
Change in child's score on the Mullen Scales of Early Learning between the permethrin and control arms
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.
Measured: Enrollment, Year 1, Year 2, Year 3
Change in child's score on the Mullen Scales of Early Learning between the etofenprox and control arms
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.
Measured: Enrollment, Year 1, Year 2, Year 3
Change in child's percentile on the Developmental Profile 4: Physical Scale between the permethrin and control arms
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.
Measured: Enrollment, Year 1, Year 2, Year 3
Change in child's percentile on the Developmental Profile 4: Adaptive Behavior Scale between the permethrin and control arms
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.
Measured: Enrollment, Year 1, Year 2, Year 3
Change in child's percentile on the Developmental Profile 4: Social-Emotional Scale between the permethrin and control arms
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.
Measured: Enrollment, Year 1, Year 2, Year 3
Change in child's percentile on the Developmental Profile 4: Cognitive Scale between the permethrin and control arms
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.
Measured: Enrollment, Year 1, Year 2, Year 3
Change in child's percentile on the Developmental Profile 4: Communication Scale between the permethrin and control arms
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.
Measured: Enrollment, Year 1, Year 2, Year 3
Change in child's percentile on the Developmental Profile 4: Physical Scale between the etofenprox and control arms
Performance on the Physical subscale of the Developmental Profile 4. 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.
Measured: Enrollment, Year 1, Year 2, Year 3
Change in child's percentile on the Developmental Profile 4: Adaptive Behavior Scale between the etofenprox and control arms
Performance on the Adaptive Behavior subscale of the Developmental Profile 4. 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.
Measured: Enrollment, Year 1, Year 2, Year 3
Change in child's percentile on the Developmental Profile 4: Social-Emotional Scale between the etofenprox and control arms
Performance on the Social-Emotional subscale of the Developmental Profile 4. 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.
Measured: Enrollment, Year 1, Year 2, Year 3
Change in child's percentile on the Developmental Profile 4: Cognitive Scale between the etofenprox and control arms
Performance on the Cognitive subscale of the Developmental Profile 4. 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.
Measured: Enrollment, Year 1, Year 2, Year 3
Change in child's percentile on the Developmental Profile 4: Communication Scale between the etofenprox and control arms
Performance on the Communication subscale of the Developmental Profile 4. 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.
Measured: Enrollment, Year 1, Year 2, Year 3
Change in child's growth score on the Developmental Profile 4: Physical Scale between the permethrin and control arms
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
Measured: Enrollment, Year 1, Year 2, Year 3
Change in child's growth score on the Developmental Profile 4: Physical Scale between the etofenprox and control arms
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
Measured: Enrollment, Year 1, Year 2, Year 3
Change in child's growth score on the Developmental Profile 4: Adaptive Behavior Scale between the permethrin and control arms
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
Measured: Enrollment, Year 1, Year 2, Year 3
Change in child's growth score on the Developmental Profile 4: Adaptive Behavior Scale between the etofenprox and control arms
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
Measured: Enrollment, Year 1, Year 2, Year 3
Change in child's growth score on the Developmental Profile 4: Social-Emotional Scale between the permethrin and control arms
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
Measured: Enrollment, Year 1, Year 2, Year 3
Change in child's growth score on the Developmental Profile 4: Social-Emotional Scale between the etofenprox and control arms
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
Measured: Enrollment, Year 1, Year 2, Year 3
Change in child's growth score on the Developmental Profile 4: Cognitive Scale between the permethrin and control arms
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
Measured: Enrollment, Year 1, Year 2, Year 3
Change in child's growth score on the Developmental Profile 4: Cognitive Scale between the etofenprox and control arms
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
Measured: Enrollment, Year 1, Year 2, Year 3
Change in child's growth score on the Developmental Profile 4: Communication Scale between the permethrin and control arms
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
Measured: Enrollment, Year 1, Year 2, Year 3
Change in child's growth score on the Developmental Profile 4: Communication Scale between the etofenprox and control arms
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
Measured: Enrollment, Year 1, Year 2, Year 3
Change in child's age equivalent on the Developmental Profile 4: Physical Scale between the permethrin and control arms
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.
Measured: Enrollment, Year 1, Year 2, Year 3
Change in child's age equivalent on the Developmental Profile 4: Physical Scale between the etofenprox and control arms
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.
Measured: Enrollment, Year 1, Year 2, Year 3
Change in child's age equivalent on the Developmental Profile 4: Adaptive Behavior Scale between the permethrin and control arms
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.
Measured: Enrollment, Year 1, Year 2, Year 3
Change in child's age equivalent on the Developmental Profile 4: Adaptive Behavior Scale between the etofenprox and control arms
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.
Measured: Enrollment, Year 1, Year 2, Year 3
Change in child's age equivalent on the Developmental Profile 4: Social-Emotional Scale between the permethrin and control arms
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.
Measured: Enrollment, Year 1, Year 2, Year 3
Change in child's age equivalent on the Developmental Profile 4: Social-Emotional Scale between the etofenprox and control arms
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.
Measured: Enrollment, Year 1, Year 2, Year 3
Change in child's age equivalent on the Developmental Profile 4: Cognitive Scale between the permethrin and control arms
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.
Measured: Enrollment, Year 1, Year 2, Year 3
Change in child's age equivalent on the Developmental Profile 4: Cognitive Scale between the etofenprox and control arms
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.
Measured: Enrollment, Year 1, Year 2, Year 3
Change in child's age equivalent on the Developmental Profile 4: Communication Scale between the permethrin and control arms
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.
Measured: Enrollment, Year 1, Year 2, Year 3
Change in child's age equivalent on the Developmental Profile 4: Communication Scale between the etofenprox and control arms
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.
Measured: Enrollment, Year 1, Year 2, Year 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2026
- Study start1 Jan 2027 (estimated)
- Primary completion1 Jan 2030 (estimated)
- Study completion1 Jan 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malaria (Plasmodium Falciparum)Studies of the same condition, open and under way.
- 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
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 1,296 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- North Carolina State University, Mbarara University of Science and Technology
- Responsible party
- Sponsor
- Investigators
- Ross Boyce, MD, MSc, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07773350
- Sponsor's protocol ID
- 26-1754
- Status last verified
- Aug 2026
- First submitted
- 14 Aug 2026
- Last updated
- 19 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.