Efficacy of Higher Albendazole and Ivermectin Doses on Wuchereria Bancrofti Microfilarial Clearance in Malawi, Open Label Study
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Number of Participants Achieving Microfilarial Clearance
研究概览
简要总结
Albendazole and ivermectin are currently used in combination for annual mass treatment of lymphatic filariasis in Africa. Although the drugs have been donated, the cost of such programmes is very high and has proven to be a major impediment to the success of programmes in many countries with limited financial resources.
Data from albendazole treatment of other filarial infections and one study comparing single to multi-dose Diethycarbamazine/albendazole in lymphatic filariasis suggest that increased dose and/or frequency of albendazole dosing may be more effective in clearing microfilariae. It is essential to determine whether such higher doses are indeed beneficial since this could have far-reaching effects on the conduct and management of the main mass treatment programmes and also in the management of programmes as they near elimination.
详细描述
The proposed study will enrol up to 120 volunteers with microfilaremic Wuchereria bancrofti infection who would be randomized to receive standard annual treatment (albendazole 400 mg + ivermectin 200 mcg/kg), annual treatment with an increased dose of albendazole (albendazole 800 mg + ivermectin 200400 mcg/kg) or semi-annual treatment with a standard (albendazole 400 mg + ivermectin 200 mcg/kg), or an increased albendazole dose (albendazole 800 mg + ivermectin 200 400 mcg/kg). Microfilarial levels, as well as measures of adult worm burden (circulating antigen) will be followed every six months for two years to determine whether the higher doses, or more frequent regimens are more effective.
The data obtained would be used, in combination with the data from other similar studies being conducted in Mali and in India to advise the Global Programme for the Elimination of Lymphatic Filariasis (GPELF) on improved methods of treatment both for mass treatment and for the management of problem areas within the global programme.
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 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •understand and sign informed consent
- •willing to undergo night blood sampling every 6 months for 2 years
- •Age 18 to 55 years
- •Haemoglobin of equal or above 9g/dl
- •Microfilarial level of equal or above 80mg/dl
排除标准
- •Non- consenting
- •Pregnancy or lactation
- •Treatment with albendazole or ivermectin within the previous 6 months
- •Known allergy to the study drugs
研究组 & 干预措施
albendazole 400mg and ivermectin 200mcg/kg
Annual treatment
干预措施: Albendazole 400mg and ivermectin 200mcg/kg (Drug)
Albendazole 800mg and ivermectin 400mcg/kg
Annual treatment
干预措施: Albendazole and ivermectin (Drug)
Albendazole 400mg and ivermectin 200mcg/kg
albendazole 400mg and ivermectin 200mcg/kg given twice a year
干预措施: Albendazole 400mg and ivermectin 200mcg/kg (Drug)
Albendazole 800mg and ivermectin 400mcg /kg bi-annually
Albendazole 800mg and ivermectin 400mcg/kg given twice a year
干预措施: albendazole 800mg and ivermectin 400mcg/kg bi-annually (Drug)
结局指标
主要结局
Number of Participants Achieving Microfilarial Clearance
时间窗: 12 months
Microfilaria clearance will be assessed in regard to dosage as well as frequency of treatment. Microfilarial clearance is defined by non-detection of microfilaria in the night blood sample.
次要结局
- Number of Participants With Microfilarial Clearance at 24 Months of Follow up(24 months)
研究者
Neil French
Reader In Infectious Disease Epidemiology/Director KPS
London School of Hygiene and Tropical Medicine