IGHID 12128 - Getting Malaria "Off the Backs" of Women and Children in Western Uganda
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 400
- 试验地点
- 2
- 主要终点
- Incidence of clinical malaria in child
研究概览
简要总结
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.
详细描述
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.
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)
盲法说明
Double
入排标准
- 年龄范围
- 6 Months 至 99 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Incidence of clinical malaria in child
时间窗: 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
次要结局
- Malaria hospitalization(14 days after onset of symptoms)
- Incidence of clinical malaria in mother(7 days after onset of symptoms)
- Change in child's growth parameters((Week 0), Week 12, and Week 24 visits)
- Change in mother's hemoglobin level((Week 0), Week 12, and Week 24 visits)
- Change in child's hemoglobin level((Week 0), Week 12, and Week 24 visits)
- Change in child's nutritional status((Week 0), Week 12, and Week 24 visits using MUAC tape)
- Prevalence of asymptomatic parasitemia(Every two weeks)
- Adverse reaction to permethrin treatment(7 days after onset)