ACTRN12622001407785尚未招募4 期
Efficacy and safety of pyronaridine-artesunate for the treatment of uncomplicated Plasmodium falciparum malaria in Gia Lai province, Viet Nam in 2022.
适应症
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 42
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
入排标准
- 年龄范围
- 7 Years 至 60 Years（—）
- 性别
- All
入选标准
- •To assess the therapeutic efficacy and safety of artesunate-pyronaridine
- •age between 07 to 60 ages;
- •mono-infection with P. falciparum detected by microscopy;
- •parasitaemia of 500 – 100,000/µl asexual forms;
- •presence of axillary temperature greater than or equal to 37.5 °C or history of fever during the past 24 h;
- •ability to swallow oral medication;
- •ability and willingness to comply with the study protocol for the duration of the study and to comply with the study visit schedule; and
- •informed consent from the patient or from a parent or guardian in the case of children.
- •informed assent from any minor participant aged from 12 to 18 years; and
- •consent for pregnancy testing from female of child-bearing age (defined as age > 12 years and sexually active) and from their parent or guardian if under the age of majority years (18 years old).
- •To assess the therapeutic efficacy and safety of chloroquine
- •age between 02 to 60 ages;
- •mono-infection with P. vivax detected by microscopy;
- •parasitaemia of 250 /µl asexual forms;
- •presence of axillary temperature greater than or equal to 37.5 °C or history of fever during the past 24 h;
- •ability to swallow oral medication;
- •ability and willingness to comply with the study protocol for the duration of the study and to comply with the study visit schedule;
- •informed consent from the patient or from a parent or guardian in the case of children.
- •informed assent from any minor participant aged from 12 to 18 years.
排除标准
- •presence of severe malaria according to the definitions of WHO ;
- •weight under 20 kg with P. falciparum patients;
- •mixed or mono-infection with another Plasmodium species detected by microscopy;
- •presence of febrile conditions due to diseases other than malaria (e.g. measles, acute lower respiratory tract infection, severe diarrhea with dehydration) or other known underlying chronic or severe diseases (e.g. cardiac, renal and hepatic diseases, HIV/AIDS);
- •regular medication, which may interfere with antimalarial pharmacokinetics;
- •a positive pregnancy test or breastfeeding; and
- •unable to or unwilling to take pregnancy test or to use contraception for women of child-bearing age and who are sexually active.
- •history of hypersensitivity reactions or contraindications to the medicine(s) being tested; and
- •Unmarried female age 12 – 18 years old.
研究者
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