Host and Parasites Factors Contributing to Risk of Plasmodium Re-infection and Morbidity in Elementary School Children in Maprik, East Sepik Province
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 524
- 试验地点
- 1
- 主要终点
- Time to first or only Plasmodium vivax infection by light microscopy and PCR
研究概览
简要总结
This study specifically seeks to quantify the contribution of relapes to the burden of P. vivax infections and disease by determining on the effect of radical pre-erythrocytic and erythrocytic clearance on subsequent rates of Plasmodium spp. infection and disease in children aged 5-10 years in a treatment to re-infection study design. In order the clear liver-stage/blood-stages G6PD-normal children were randomised to receive Chloroquine (3 days, standard dose) and Coartem (3 days, standard dose) plus either i) primaquine (20 days, 0.5mg/kg) or ii) placebo (20days). These drugs were administered over a period of 4 weeks.
In addition to this epidemiological data, the study will assess the natural acquisition of cellular and humoral immune responses to P. falciparum and P. vivax, thus assisting in the determination of correlates of clinical immunity to P. falciparum and P. vivax in PNG children aged 5-10 years.
These data will not only be essential for development of future vaccines against P. vivax and P falciparum but provide invaluable insight into the contribution of long-lasting liver-stages to the force of infection with P. vivax that will contribute towards designing more rational approaches to the treatment of P. vivax both in the context of case management and future attempts at elimination.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 5 Years 至 10 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •aged 5-10 years (±3 months)
- •permanent residents of the area
- •absence of history of hypersensitivity reactions to the drugs
排除标准
- •chronic illness
- •severe malnutrition (weight-for-age nutritional Z score [WAZ] <60th percentile)
- •severe anemia (Hb <5 g/dL),
- •G-6-PD deficiency (<60% G-6-PD activity)
- •permanent disability, which prevents or impedes study participation. Any 1 or more of the criteria is sufficient to exclude study participation.
研究组 & 干预措施
Primaquine
Primaquine, 0.5mg/kg/day, 20 days directly observed treatment Chloroquine, 25mg/kg total dose, divided over 3 days directly observed treatment Artemether-Lumefantrine, 3 days BD
干预措施: Primaquine (Drug)
Primaquine
Primaquine, 0.5mg/kg/day, 20 days directly observed treatment Chloroquine, 25mg/kg total dose, divided over 3 days directly observed treatment Artemether-Lumefantrine, 3 days BD
干预措施: Chloroquine (Drug)
Primaquine
Primaquine, 0.5mg/kg/day, 20 days directly observed treatment Chloroquine, 25mg/kg total dose, divided over 3 days directly observed treatment Artemether-Lumefantrine, 3 days BD
干预措施: Artemether Lumefantrine (Drug)
Placebo
Placebo, 20 days directly observed treatment Chloroquine, mg/kg, 3 days directly observed treatment Artemether-Lumefantrine, 3 days BD
干预措施: Placebo (Drug)
Placebo
Placebo, 20 days directly observed treatment Chloroquine, mg/kg, 3 days directly observed treatment Artemether-Lumefantrine, 3 days BD
干预措施: Chloroquine (Drug)
Placebo
Placebo, 20 days directly observed treatment Chloroquine, mg/kg, 3 days directly observed treatment Artemether-Lumefantrine, 3 days BD
干预措施: Artemether Lumefantrine (Drug)
结局指标
主要结局
Time to first or only Plasmodium vivax infection by light microscopy and PCR
时间窗: 8 months post-baseline
Time to first or only clinical P. vivax episode
时间窗: 8 months post-baseline
次要结局
- Time to first or only P. falciparum infection by light microscopy and PCR(8 months post-baseline)
- Time to first or only P. ovale infection by light microscopy and PCR(8 months post-baseline)
- Time to first or only P. malariae infection by light microscopy and PCR(8 months post-baseline)