P. Falciparum Infection Dynamics and Transmission to Inform Elimination (INDIE-1a)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 907
- 试验地点
- 1
- 主要终点
- Parasite prevalence and density by molecular detection at the end of study cross-sectional survey.
研究概览
简要总结
In the current randomized trial, the investigators will test the ability of two experimental approaches to malaria infection management to reduce malaria transmission potential. Compounds in Saponé, Burkina Faso, will be randomized to 1 of 3 study arms: arm 1 - current standard of care with passively monitored malaria infections; arm 2 - standard of care plus enhanced community case management (CCM), comprising active weekly screening for fever, and detection and treatment of infections in fever positive individuals using conventional rapid diagnostic tests (RDTs); or arm 3 - standard of care and enhanced CCM, plus monthly screening and treatment (MSAT) using RDTs. The study will be conducted over approximately 18 months covering two high transmission seasons and the intervening dry season
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participants should be permanent residents of the compound
- •Participants should be willing to participate in repeated assessments of health and infection status and willing to donate a maximum of 37mL of blood (children <10 years of age) or 52mL of blood (older individuals) during an 18-month period
排除标准
- •Any (chronic) illness that would affect with study participation
- •Pre-existing severe chronic health conditions
- •Current participation in malaria vaccine trials or participation in such trials in the last 2 years
- •History of intolerance to artemether-lumefantrine
结局指标
主要结局
Parasite prevalence and density by molecular detection at the end of study cross-sectional survey.
时间窗: Month 18 (end of second transmission season; January-February 2020)
The primary outcome measure is parasite prevalence in the cross-sectional survey conducted at the end of the transmission season of year 2. If CCM and MSAT result in the early detection of infections, parasite prevalence at the end of the study will be lower in these arms compared to the control arm.
次要结局
- Parasite prevalence and density by molecular detection at the end of year 1 cross-sectional survey.(Month 6 (end of first transmission season; January-February 2019))
- Parasite prevalence and density by molecular detection at the end of dry season cross-sectional survey.(Month 12 (prior to second transmission season; June 2019))
- Gametocyte prevalence and or density in P. falciparum infections at the end of study cross-sectional survey(Month 18 (end of second transmission season; January-February 2020))
- Gametocyte prevalence and or density in P. falciparum infections at the end of year 1 cross-sectional survey(Month 6 (end of first transmission season; January-February 2019))
- Gametocyte prevalence and or density in P. falciparum infections at the end of dry season cross-sectional survey(Month 12 (prior to second transmission season; June 2019))
- Gametocyte prevalence and or density in P. falciparum during all study visits(Throughout study, an average of 18 months)
- The number of incident infections.(Throughout study, an average of 18 months)
- Infectivity to mosquitoes of P. falciparum infections(Throughout study, an average of 18 months)