ACTRN12621001085864招募中4 期
Therapeutic efficacy surveillance of malaria treatment and drug resistance monitoring in Gia Lai and Phu Yen provinces of Central Vietnam
Australian Defence Force Malaria and Infectious Disease Institute0 个研究点目标入组 210 人开始时间: 2021年8月17日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 210
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomised trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 5 Years 至 60 Years(—)
- 性别
- All
入选标准
- •People infected with uncomplicated mono-infections of P. falciparum and uncomplicated mono-infections of P. vivax;
- •Malaria parasite density of P. falciparum (= 500 to < 100,000 parasites/µL);
- •Malaria parasite density of P. vivax (= 250 parasites/µL);
- •Children (=5 years and =20 kg to <18 years old) and adults (=18 to <60 years old) infected with P. falciparum, children (=5 to <18 years old) and adults (=18 to <60 years old) infected with P. vivax malaria;
- •Gender: Males and females;
- •Working or residing at the study commune;
- •Able to provide information and capillary finger prick blood samples;
- •Written informed consent given to participate in the study by the adult or in case of children up to <18 years old (Assent form for children aged 12 to <18 years old) with parent or guardian permission;
- •Normal G6PD enzyme activity levels (>70%) of the site median value for G6PD normals for participants to be treated with primaquine for the radical cure of P. vivax malaria.
排除标准
- •People not infected with malaria infections;
- •Children (<5 years old and <20 kg)infected with P. falciparum and less than 5 years of age infected with P. vivax malaria;
- •Unwilling to provide consent, information, and capillary finger prick blood sample;
- •Inability to communicate well with the study staff (poor mental development or evidence of psychiatric disorder);
- •People with P. vivax malaria who have G6PD deficient enzyme activity;
- •Pregnant or lactating females;
- •Any condition that in the judgment of the IMPE-QN/MIPM doctor would make participation in the study unsafe for the potential participant.
研究者
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