Efficacy of Dried Leaf Artemisia (DLA) Versus Coartem (ACT): A Randomized Controlled Clinical Trial for Comparing DLA vs. ACT to Treat Malaria
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Change in gametocyte reduction/elimination
研究概览
简要总结
The overall goal is to validate efficacy and potential superiority of dried leaf Artemisia annua (DLA) vs. artemisinin combination therapy (ACT) to cure malaria and to demonstrate elimination of the transmission stage (gametocytes) of the disease. This is a 3 arm trial in Democratic Republic of Congo covering 600 total adult and pediatric patients. Final validation of infection from dried blood samples will be done at WPI.
详细描述
A clinical trial in DR Congo to validate that oral consumption of dried leaf tablets of the plant Artemisia annua can cure malaria and prevent its transmission.
PI: Pamela Weathers, Ph.D. & Prof. of Biology and Biotechnology, Lead Institution: Worcester Polytechnic Institute, 100 Institute Rd, Worcester, MA 01609
Background:
The plant Artemisia annua produces artemisinin, which is currently extracted and purified from the plant and used to produce the current standard of antimalarial care, artemisinin combination therapy (ACT). While some human trials have been done using dried leaf Artemisia (DLA) to treat malaria, none has been extensive enough to provide evidence convincing to the key regulatory bodies, e.g. WHO. There is animal and human evidence suggesting that DLA not only is highly efficacious at low doses, but also treats ACT-resistant malaria and may inhibit development of the gametocytes, which is the blood parasite stage that enables retransmission to the next mosquito host. ACTs have not shown full efficacy in quelling transmission. Furthermore, ACT drug resistance is now confirmed in Southeast Asia and may be emerging in Africa. Thus, this study is unique, timely and needed because:
- DLA has not been studied yet in a larger human trial.
- DLA has not been compared in a human trial to the current ACT antimalarial therapy.
- DLA shows promise at inhibiting the gametocyte transmission stage of malaria and would thereby break the cycle of malaria.
- Investigators have a full supply chain in place to grow, produce and package DLA tablets in a GMP facility and have distribution channels ready to deliver the drug to pharmacies in Eastern Africa.
- Investigators' therapeutic approach is less costly than ACT and is under the control of Africans; therapeutics by and for Africans.
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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Positive RDT for malaria and
- •Positive blood smear for malaria.
排除标准
- •All pregnant mothers less than 12 weeks gestational age.
- •Children weighing less than 5 kg.
- •Patients who have taken any antimalarial immediately prior to study admission.
- •All patients with any form of severe malaria.
研究组 & 干预措施
ACT
Standard Artemisinin Combination Therapy (ACT) being used as currently approved antimalarial therapy at WHO and manufacturer recommended dosage. The specific ACT used is artemether-lumefantrine (Coartem). Form is scored tablets that each contain 20 mg artemether and 120 mg lumefantrine.
Tablets per dose, are given BID for 3 days as shown below:
Coartem tablets/dose by bodyweight; tablets/day morning and evening for total of 6 doses over 3 days
Body weight (kg) and Tablets: 5 to <15 kg, 1 tab; 15 to <25 kg, 2 tabs; 25 to <35 kg, 3 tabs; 35 kg and over, 4 tabs.
干预措施: ACT (Drug)
DLA1
Dried leaf Artemisia annua (DLA) from 0.25-1 g total/day, BID. DLA is given as 500 mg tablets according to body weight (see below) for 5 days.
DLA tablets/dose by bodyweight; tablets/day, morning and evening, for total of 10 doses over 5 days.
Body weight (kg) and tablets/dose:
For DLA1x: 5 to < 15 kg, 1/4 tab; 15-30 kg, 1/2 tab; 1/2>30 kg, 1 tab.
干预措施: DLA1 (Drug)
DLA2
Dried leaf Artemisia annua (DLA) from 0.5-2 g total/day, BID. DLA is given as 500 mg tablets according to body weight (see below) for 5 days.
DLA tablets/dose by bodyweight; tablets/day, morning and evening, for total of 10 doses over 5 days.
Body weight (kg) and tablets/dose:
For DLA2x: 5 to < 15 kg, 1/2 tab; 15-30 kg, 1 tab; >30 kg, 2 tabs.
干预措施: DLA2 (Drug)
结局指标
主要结局
Change in gametocyte reduction/elimination
时间窗: Day 28 for both microscopic and qPCR measurements.
Use microscopy and qPCR to compare change in gametocyte carriage among the 3 treatment arms.
Change in parasitemia elimination
时间窗: Day 28 for each patient.
Use microscopy to measure and compare parasitemia elimination in the blood of patients among the 3 treatment arms.
次要结局
- Reduced side effects by DLA vs. ACT among the 3 arms(Through 28 days for each patient.)
研究者
Pamela Weathers
Professor of Biology and Biotechnology
Worcester Polytechnic Institute