Efficacy of Three Different Bi-treated Long Lasting Insecticidal Nets and Deployment Strategy for Control of Malaria Transmitted by Pyrethroid Resistant Vectors: A Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 4,200
- 试验地点
- 1
- 主要终点
- Malaria infection prevalence in children 6 months to 14 years
研究概览
简要总结
The massive scale-up of Long Lasting Insecticidal Nets (LLIN) has led to a major reduction in malaria burden (up to 50%) in many sub-Saharan African countries. This progress is threatened by the wide scale selection of insecticide resistant malaria vectors. New types of LLIN combining a mixture of two insecticides or an insecticide and a synergist have been developed to control resistant mosquitoes.
The efficacy of three bi-treated LLIN are compared to a standard LLIN in a four-arm, single blinded, cluster-randomized trial in Misungwi district, Tanzania. The arms are; 1/ Royal Guard, a net combining pyriproxyfen (PPF), which is known to disrupt female reproduction and fertility of eggs, and the pyrethroid alpha-cypermethrin, 2/Interceptor G2, LLIN incorporating a mixture of two adulticides with different modes of action; chlorfenapyr and a pyrethroid (alpha-cypermethrin), and 3/ Olyset Plus an LLIN which incorporates a synergist, piperonyl butoxide (PBO), to enhance the potency of pyrethroid insecticides, and 4/ The control arm: Interceptor treated a standard LLIN treated with alpha-cypermethrin.
The primary outcome of the trial will be cross-sectional community prevalence of malaria infection (by RDT) in children aged 6 months to 14 years at 12 and 24 months post-intervention.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 6 Months 至 14 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •At least one child between 6 months to 14 years old having permanent residence in selected household
- •Having an adult caregiver willing to provide written consent for the household and clinical survey
排除标准
- •Dwelling not found or vacant during the survey
- •No adult caregiver capable to give informed consent
- •Children severely ill
研究组 & 干预措施
Piperonyl butoxide LLIN
Olyset® Plus (Sumitomo Chemicals) is a LLIN combining Piperonyl butoxide (400mg/m2) and the repellent pyrethroid permethrin (800 mg/m2) incorporated into the polyethylene fibres. This LLIN will be distributed to all the households in 21 clusters on a 1 LLIN per two household residents basis.
干预措施: Piperonyl butoxide LLIN (Other)
Pyriproxyfen LLIN
Royal Guard® (Disease Control Technologies, LLC) is a Long Lasting Insecticidal Net made of polyethylene incorporating a mixture of 225 mg/m2 pyriproxyfen and 261mg/m2 alpha-cypermethrin. This LLIN will be distributed to all the households in 21 clusters on a 1 LLIN per two household residents basis.
干预措施: pyriproxyfen LLIN (Other)
Chlorfenapyr LLIN
Interceptor® G2 (BASF corporation) is a LLIN made of polyester coated with a wash-resistant formulation of 200 mg/m2 chlorfenapyr and 100 mg/m2 alpha-cypermethrin. This LLIN will be distributed to all the households in 21 clusters on a 1 LLIN per two household residents basis.
干预措施: Chlorfenapyr LLIN (Other)
Standard LLIN
Interceptor® (BASF Corporation) is a single pyrethroid-treated LLIN with alpha-cypermethrin (coated onto filaments) at a target dose of 200 mg/m2 of polyester fabric. This LLIN will be distributed to all the households in 21 clusters on a 1 LLIN per two household residents basis.
干预措施: Standard LLIN (Other)
结局指标
主要结局
Malaria infection prevalence in children 6 months to 14 years
时间窗: 24 months post intervention
Malaria prevalence will be assessed using Malaria Rapid Diagnostic test (CareStart Malaria histidine-rich protein 2 (HRP2)/plasmodium lactate dehydrogenase (pLDH) Combo, DiaSys, UK)
次要结局
- Insecticide content in Long Lasting Insecticidal Net (LLIN)(at 0, 12, 24, 30, 36 months post intervention)
- Mortality in Anopheles after one hour exposure to every study LLIN(at 0, 6, 12, 18, 24, 30, 36 months post intervention)
- Malaria infection prevalence in children 6 months to 14 years(36 months post intervention)
- Cost & DALYs of each type of bi-treated LLIN(Three years post intervention)
- LLIN usage(at 6, 12, 18, 24, 30, 36 months post intervention)
- Incidence of malaria cases in children 6 months to 10 years(Two years post intervention follow up)
- Prevalence of anaemia in children under 5 years old(12, 18, 24, 30, 36 months post intervention)
- Indoor Anopheles density(Three years post intervention follow up)
- Sporozoite rate(Three years post intervention follow up)
- Malaria infection prevalence in children 6 months to 14 years(12 months post intervention)
- Malaria infection prevalence in children 6 months to 14 years(18 months post intervention)
- Malaria infection prevalence in children 6 months to 14 years(30 months post intervention)