NCT01603251已完成1 期
A Double Blind Randomized Controlled Trial of Artemether-Lumefantrine Alone and in Combination With Ivermectin to Reduce Post-Treatment Malaria Transmission
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Safety
研究概览
简要总结
The purpose of this study is to determine the safety and impact of ivermectin, administered as single or repeated dose, in combination with artemether-lumefantrine in reducing the proportion of mosquitoes that survive and become infected after feeding on a blood meal from a malaria-infected individual.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 15 Years 至 25 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •asymptomatically infected individuals with any P. falciparum parasite density
排除标准
- •age < 15 years or > 25 years
- •malaria parasite density ≥ 10,000 parasites/µL
- •clinical symptoms indicating severe malaria
- •axillary temperature ≥ 37.5°C
- •Body Mass Index (BMI) below 18 or above 32 kg/m2
- •haemoglobin concentration below 11 g/dL
- •taken ivermectin in the last three months
- •Loa loa as assessed by questionnaire, clinical examination and parasitological assessments
- •for women: pregnancy or lactation
- •known hypersensitivity to AL or IVM
- •history and/or symptoms indicating chronic illness
- •current use of tuberculosis or anti-retroviral medication
- •unable to give written informed consent
- •unwillingness to participate in two membrane feeding assays
- •travel history to Angola, Cameroon, Chad, Central African Republic, Congo, DR Congo, Equatorial Guinea, Ethiopia, Gabon, Nigeria and Sudan. If a potential participant has ever visited one or more of these countries, he or she will not be eligible for enrolment.
- •history of cardiovascular disease.
- •taking drugs that are known to influence cardiac function and to prolong QTc interval, such as class IA and III: neuroleptics, antidepressant agents, certain antibiotics including some agents of the following classes - macrolides, fluoroquinolones, imidazole, and triazole antifungal agents, certain non-sedating antihistaminics (terfenadine, astemizole) and cisapride.
- •known disturbances of electrolyte balance, e.g. hypokalaemia or hypomagnesaemia.
- •taking drugs which may be metabolized by cytochrome enzyme CYP2D6 (e.g., flecainide, metoprolol, imipramine, amitriptyline, clomipramine).
研究组 & 干预措施
Artemether-Lumefantrine
Active Comparator
干预措施: Artemether-lumefantrine combination (Drug)
Artemether-Lumefantrine + single dose Ivermectin
Experimental
干预措施: Artemether-lumefantrine combination + single dose Ivermectin (Drug)
Artemether-Lumefantrine + repeated dose Ivermectin
Experimental
干预措施: Artemether-lumefantrine combination + repeated dose Ivermectin (Drug)
结局指标
主要结局
Safety
时间窗: 8 days
The number of adverse events; number of participants with abnormal haemoglobin, biochemistry or full blood count values
次要结局
- Mosquitocidal activity(feeding experiments performed up to 8 days after enrolment; survival of mosquitoes determined up to day 10 after feeding)
研究者
研究点 (1)
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