Clinical Assessment of the Safety and Efficacy of Artemisia Annua Infusion Preparation for the Treatment of Asymptomatic Plasmodium Falciparum Infection in Semi-immune Adults in Gabon
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Number of participants in whom the parasitaemia was cleared
研究概览
简要总结
The goal of this clinical trial is to determine whether Artemisia annua dried leaves, used as an infusion, can treat individuals with malaria parasites but no symptoms. The main question it aims to answer is:
Can Artemisia annua infusion be used to treat malaria?
Researchers will compare those receiving Artemisia annua infusion with those receiving an infusion of Centaurii herba (which has no effect on malaria parasites) to see whether all individuals treated with Artemisia annua infusion are cured, which should not be the case for those receiving Centaurii herba infusion.
Participants will
- drink Artemisia annua infusion over seven days (three days at our research centre and four days at their home
- visit the research centre once a week for three weeks after treatment for one month for safety reasons
详细描述
For safety reasons, participants will be followed up daily for malaria-like symptoms and parasite counts until the end of treatment. Indeed, if they are not free of parasites after seven days of treatment, they will receive rescue treatment, which is the WHO-recommended malaria treatment.
Similarly, if the number of parasites in their blood increases or they develop malaria-like symptoms during treatment, they will receive rescue treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: 18 to 45 years
- •Absence of fever (body temperature <37.5ºC axillary or <38.0°C oral, rectal or tympanic temperature)
- •Asymptomatic P. falciparum infection with parasitemia between 500 and 2,000 asexual P. falciparum parasites per μl of blood
- •Have been living in an endemic area for at least 5 years.
- •Written informed consent from the participant
- •Residence in the vicinity of the study centre
- •Willingness to comply with the follow-up schedule
排除标准
- •History of fever over the last 72 hours
- •Non-Plasmodium falciparum infection
- •Intake of any antimalarial drug or antibiotic with antimalarial activity within the previous 28 days and/or after half-life time
- •Presence of signs and symptoms related by the medical doctor to malaria
- •Known history or evidence of clinically significant medical disorders
- •Severe malnutrition
- •Haemoglobin concentration <7 g/dL
- •Known hypersensitivity and contraindications to any study medication
- •Pregnancy or lactation
- •Participation in other interventional studies
研究组 & 干预措施
Control arm
干预措施: Centaurii herba (Drug)
Artemisia arm
干预措施: Artemisia Annua Leaf (Drug)
结局指标
主要结局
Number of participants in whom the parasitaemia was cleared
时间窗: On day 7 from the first day of treatment
No parasites detected in the thick blood smear (microscopic method)
次要结局
- Number of participants cured(From the last day of treatment (day 7) to the end of the follow-up period on day 28)
- Number of adverse events(From the first day of treatment (enrolment) to the end of the treatment period on day 7)