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临床试验/NCT07773350
NCT07773350尚未招募不适用

Factory-Treated, Long-Lasting Insecticide-Treated Baby Wraps for the Prevention of Malaria: A Phase III Clinical Trial

University of North Carolina, Chapel Hill1 个研究点 分布在 1 个国家目标入组 1,296 人开始时间: 2027年1月1日最近更新:
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适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
1,296
试验地点
1
主要终点
Incidence of clinical malaria in children between the etofenprox and control arms
研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The objective is to test the protective effect of permethrin-treated and etofenprox-treated lesus against malaria in young children

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Double (Participant, Care Provider)

入排标准

年龄范围
2 Months 至 99 Years（Child, Adult, Older Adult）
性别
All
接受健康志愿者
是

入选标准

  • •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

排除标准

  • •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

研究组 & 干预措施

Receives permethrin-treated lesu

Experimental

Receives permethrin-treated lesu for 2 years

干预措施: Permethrin-treated lesu (Other)

Receives etofenprox-treated lesu

Experimental

Receives etofenprox-treated lesu for 2 years

干预措施: Etofenprox-treated lesu (Other)

Receives non-treated lesu

Sham Comparator

Receives the non-treated lesu for 2 years

干预措施: Untreated lesu (Other)

结局指标

主要结局

Incidence of clinical malaria in children between the etofenprox and control arms

时间窗: From enrollment through Month 24

Incidence of participants experiencing acute febrile illness AND positive malaria rapid diagnostic test (RDT) at a scheduled or unscheduled study visit.

Incidence of clinical malaria in children between the permethrin and control arms

时间窗: From enrollment through Month 24

Incidence of participants experiencing acute febrile illness AND positive malaria RDT at a scheduled or unscheduled study visit.

次要结局

  • Incidence of non-malarial febrile episodes in children between the etofenprox and control arms(From enrollment through Month 24)
  • Wrap attrition(From enrollment through Month 24)
  • Incidence of rebound clinical malaria in children between the permethrin and control arms(From Month 24 through Month 36)
  • Incidence of rebound clinical malaria in children between the etofenprox and control arms(From Month 24 through Month 36)
  • Number of adverse reactions to wraps between the permethrin and control arms(From enrollment through Month 24)
  • Number of adverse reactions to wraps between the etofenprox and control arms(From enrollment through Month 24)
  • Number of participants with care-seeking events attributable to the permethrin wrap versus the control(From enrollment through Month 24)
  • Number of participants with care-seeking events attributable to the etofenprox wrap versus the control(From enrollment through Month 24)
  • Number of participants with hospitalizations attributable to the permethrin wrap versus the control(From enrollment through Month 24)
  • Number of participants with hospitalizations attributable to the etofenprox wrap versus the control(From enrollment through Month 24)
  • Number of participants with death attributable to the permethrin wrap versus the control(From enrollment through Month 24)
  • Number of participants with death attributable to the etofenprox wrap versus the control(From enrollment through Month 24)
  • Change in child's height-for-weight between the permethrin and control arms(From enrollment through Month 24)
  • Change in child's height-for-weight between the etofenprox and control arms(From enrollment through Month 24)
  • Change in child's height-for-age between the permethrin and control arms(From enrollment through Month 24)
  • Change in child's height-for-age between the etofenprox and control arms(From enrollment through Month 24)
  • Change in child's weight-for-age between the permethrin and control arms(From enrollment through Month 24)
  • Change in child's weight-for-age between the etofenprox and control arms(From enrollment through Month 24)
  • Change in child's acute malnutrition between the permethrin and control arms(From enrollment through Month 24)
  • Change in child's acute malnutrition between the etofenprox and control arms(From enrollment through Month 24)
  • Change in child's score on the Mullen Scales of Early Learning between the permethrin and control arms(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(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(Enrollment, Year 1, Year 2, Year 3)
  • Incidence of clinical malaria in children between the permethrin and control arms per site(From enrollment through Month 24)
  • Incidence of clinical malaria in children between the etofenprox and control arms per site(From enrollment through Month 24)
  • Incidence of hospitalizations due to malaria between the permethrin and control arms(From enrollment to Month 36)
  • Incidence of hospitalizations due to malaria between the etofenprox and control arms(From enrollment to Month 36)
  • Number of deaths from any cause between the permethrin and control arms during wrap use(From enrollment to Month 24)
  • Number of deaths from any cause between the etofenprox and control arms during wrap use(From enrollment to Month 24)
  • Number of deaths from any cause between the permethrin and control arms after wrap use has been discontinued(From Month 24 to Month 36)
  • Number of deaths from any cause between the etofenprox and control arms after wrap use has been discontinued(From Month 24 to Month 36)
  • Number of deaths from malaria between the permethrin and control arms during wrap use(From enrollment to Month 24)
  • Number of deaths from malaria between the etofenprox and control arms during wrap use(From enrollment to Month 24)
  • Number of deaths from malaria between the permethrin and control arms after wrap use has been discontinued(From Month 24 to Month 36)
  • Number of deaths from malaria between the etofenprox and control arms after wrap use has been discontinued(From Month 24 to Month 36)
  • Difference between the permethrin and control arms in change from baseline of childrens' hemoglobin levels(At baseline, 12 Months, and 24 Months)
  • Difference between the etofenprox and control arms in change from baseline of childrens' hemoglobin levels(At baseline, 12 Months, and 24 Months)
  • Incidence of non-malarial febrile episodes in children between the permethrin and control arms(From enrollment through Month 24)
  • Change in child's percentile on the Developmental Profile 4: Adaptive Behavior Scale between the permethrin and control arms(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(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(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(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(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(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(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(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(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(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(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(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(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(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(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(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(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(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(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(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(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(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(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(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(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(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(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(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(Enrollment, Year 1, Year 2, Year 3)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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