Comparison of Ivermectin Alone With Albendazole (ALB) Plus Ivermectin (IVM) in Their Efficacy Against Onchocerciasis in the Volta Region, Ghana.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 375
- 试验地点
- 1
- 主要终点
- parasitologic efficacy
研究概览
简要总结
We will examine whether a combination of Ivermectim (IVM) plus Albendazole (ALB) compared to IVM alone given annually, which is the current standard for mass drug administration (MDA), is more effective in sterilizing adult worms. We will also address whether IVM plus ALB given twice per year is superior to IVM given once per year or twice per year.
详细描述
We hypothesize that more effective combinations of dose schedules of existing antifilarial drugs for MDA against onchocerciasis could shorten the number of years needed to interrupt onchocerciasis transmission and eliminate this infectious disease in areas that previously had high disease rates. Improved treatments should also make it feasible to extend MDA into areas that are currently not being helped. These changes have the potential to completely change the game to make global elimination of onchocerciasis a feasible goal.
Participants will be randomized into 5 treatment arms with 75 subjects in each arm for a total of 375 and followed for 36 months after the initial treatment. The primary endpoint will be the percent fertile adult female worms in nodules removed 36 months after the initiation of treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women 18-60 years residing along the Kpassa in the Nkwanta North District of the Volta Region in Ghana
- •Two or more assessable onchocercal nodules
- •Skin microfilaria density ≥5mf/mg.
排除标准
- •Prior treatment with the antifilarial and/or anti-nematodal drugs diethylcarbamazine, suramin, ivermectin, albendazole, levamisole or >1week of treatment with doxycycline, within 12 months before planned test article administration.
- •Pregnant or breastfeeding women.
- •Low probability of residency in the area (based on subject's assessment) over the next 36 months.
- •Permanent disability, serious medical illnesses such as a stroke, advanced heart disease, uncontrolled diabetes, emphysema, etc. that prevents or impedes study participation and/or comprehension
- •Weight of <40kg suggesting malnourishment
- •Hemoglobin levels <7 gm/dL
- •aspartate aminotransferase, alanine aminotransferase, creatinine > 1.5 upper limit of normal.
- •Significant glycosuria or proteinuria (2+ or 3+ protein or glucose).
- •Known or suspected allergy to albendazole or ivermectin or other compounds related to these classes of medication.
研究组 & 干预措施
Annual Ivermectin
Ivermectin 200 µg/kg body weight given orally at 0, 12 and 24 months
干预措施: IVM (Drug)
Biannual IVM 200 µg/kg plus ALB 800 mg
IVM 200 µg/kg plus ALB 800 mg (regardless of weight) given at 0, 6, 12, 18, and 24 months.
干预措施: IVM plus ALB (Drug)
Annual IVM 200 µg/kg plus ALB 800 mg
IVM 200 µg/kg plus ALB 800 mg given at 0, 12 and 24 months; vitamin pills at given at 6 and 18 months.
干预措施: IVM plus ALB (Drug)
Biannual IVM 200 µg/kg
IVM 200 µg/kg given 0, 6, 12, 18, and 24 months.
干预措施: IVM (Drug)
IVM 200 µg/kg plus ALB 400 mg
IVM 200 µg/kg plus ALB 400 mg given at 0, 6, 12, 18, and 24 months.
干预措施: IVM plus ALB (Drug)
结局指标
主要结局
parasitologic efficacy
时间窗: 36 months
To compare the parasitologic efficacy, as measured by percent fertile adult female worms in nodules at 36 months after administration of annual doses of oral ivermectin alone versus ivermectin plus albendazole given annually or biannually in the treatment of subjects infected with Onchocerca volvolus
次要结局
- additional measures of parasitologic efficacy(0, 6, 12, 18, 24 and 36 months)
- compare the percentage living versus dead female worms(36 months)
- assess different treatment regimens on Soil Transmitted Helminth infections(0, 6, 12, 18, 24 and 36 months)
- determine if IVM plus ALB enhances immunological reactions(0, 6, 12, 18, 24 and 36 months)
- determine if the host immune response facilitates killing or sterilizing adult worms and microfilariae(0, 6, 12, 18, 24 and 36 months)
- compare the number of nodules with intact microfilaria(36 months)
研究者
Christopher L. King, MD, PhD
Principal Investigator
University Hospitals Cleveland Medical Center