A Multi-site Cohort Observational Study for Molecular Assessment of Artemisinin Resistance Falciparum Malaria in Myanmar
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 550
- 试验地点
- 1
- 主要终点
- Proportion of adequate clinical and parasitological response (ACPR)
研究概览
简要总结
Efficacy and safety of the artemisinin combination therapy (ACT) in uncomplicated falciparum malaria patients in Myanmar and artemisinin molecular markers analysis
详细描述
The investigators assessed the efficacy and safety of the ACT in uncomplicated falciparum malaria in different sentinel sites in Myanmar. The recruited patients were follow-up until day 28 or day-42 based on the ACTs. Day-0 samples were analysed for artemisinin molecular markers, (K13 kelch propeller, Pfmdr2, Pffd and Pfarps10).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 3 Months 至 69 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Plasmodium falciparum mono infection by microscopy
- •Presence of axillary equal to or more than 37.5 degrees centigrade or history of fever during the past 24 hours
- •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
排除标准
- •Presence of signs of severe falciparum malaria according to the definitions of World Health Organisation (WHO)
- •Mixed or mono-infection with another Plasmodium species detected by microscopy
- •Presence of severe malnutrition (defined as a child whose growth standard is below 3 z-score, has symmetrical oedema involving at least the feet or has a mid-upper arm circumference below 110 mm)
- •Presence of febrile conditions due to diseases other than malaria (e.g. measles, acute lower respiratory tract infection, severe diarrhoea with dehydration) or other known underlying chronic or severe diseases (e.g. cardiac, renal and hepatic diseases, Human Immune Deficiency Virus (HIV)/Acquired Immune Deficiency Syndrom (AIDS)
- •Regular medication, which may interfere with antimalarial pharmacokinetics
- •History of hypersensitivity reactions or contraindications to any of the medicine(s) being tested or used as alternative treatment(s)
- •A positive pregnancy test or breastfeeding
- •Unable to or unwilling to take a pregnancy test or contraceptives
研究组 & 干预措施
Kawthaung Site
The efficacy and safety of the ACT in different sentinel sites will be assessed. The administrated anti-malarial were same and all will be administrated under direct observation. The dosage will be calculated by weight of the patients. Kawthaung is one of the sentinel site and located at the Southern Myanmar.
干预措施: First line antimalarial in Myanmar (artemether-lumefrantrine, dihydroartemisinin-piperaquine, and artesunate-mefloquine) (Drug)
Myawaddy Site
The efficacy and safety of the ACT in different sentinel sites will be assessed. The administrated anti-malarial were same and all will be administrated under direct observation. The dosage will be calculated by weight of the patients. Myawaddy is one of the sentinel site and located at the northern part of the Southern Myanmar.
干预措施: First line antimalarial in Myanmar (artemether-lumefrantrine, dihydroartemisinin-piperaquine, and artesunate-mefloquine) (Drug)
Thanbyuzayat Site
The efficacy and safety of the ACT in different sentinel sites will be assessed. The administrated anti-malarial were same and all will be administrated under direct observation. The dosage will be calculated by weight of the patients. Thanbyuzayat is one of the sentinel site and located at the northern part of the Southern Myanmar.
干预措施: First line antimalarial in Myanmar (artemether-lumefrantrine, dihydroartemisinin-piperaquine, and artesunate-mefloquine) (Drug)
Shwegyin Site
The efficacy and safety of the ACT in different sentinel sites will be assessed. The administrated anti-malarial were same and all will be administrated under direct observation. The dosage will be calculated by weight of the patients. Shwegyin is one of the sentinel site and located at the southern part of the central Myanmar.
干预措施: First line antimalarial in Myanmar (artemether-lumefrantrine, dihydroartemisinin-piperaquine, and artesunate-mefloquine) (Drug)
Magway Site
The efficacy and safety of the ACT in different sentinel sites will be assessed. The administrated anti-malarial were same and all will be administrated under direct observation. The dosage will be calculated by weight of the patients. Magway is one of the sentinel site and located at the middle part of the central Myanmar.
干预措施: First line antimalarial in Myanmar (artemether-lumefrantrine, dihydroartemisinin-piperaquine, and artesunate-mefloquine) (Drug)
Rakhine Site
The efficacy and safety of the ACT in different sentinel sites will be assessed. The administrated anti-malarial were same and all will be administrated under direct observation. The dosage will be calculated by weight of the patients. Rakhine is one of the sentinel site and located at the western Myanmar.
干预措施: First line antimalarial in Myanmar (artemether-lumefrantrine, dihydroartemisinin-piperaquine, and artesunate-mefloquine) (Drug)
结局指标
主要结局
Proportion of adequate clinical and parasitological response (ACPR)
时间窗: day 28 or day 42 after initial dose of ACT
For artesunate-mefloquine or dihydroartemisinin-piperaquine, 42 days follow-ups and for artemether-lumefrantrine combinations, 28 days followe-ups
次要结局
- Proportion of the day-3 parasite positivity after ACT by microscopy(3rd day after initial dose of ACT)
- Treatment failure rate(anytime within observation period (28/42 days after treatment with one of ACTs))
- Mutant rate(Day-0 samples)
研究者
Myat Htut Nyunt
Research Scientist
Department of Medical Research, Lower Myanmar