Evaluate Triple-Drug Therapy With Diethylcarbamize (DEC), Albendazole (ALB) and Ivermectin (IVM) That Could Accelerate LF Elimination Outside of Africa
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 182
- 试验地点
- 1
- 主要终点
- Percentage of subjects with total clearance of in Wuchereria bancrofti (Wb) microfilaria (mf)
研究概览
简要总结
This study will determine if a combination of 3 drugs used to treat the infection that cause lymphatic filariasis (LF) due to Wuchereria bancrofti infection are more effective in killing or sterilizing the adult worms compared to just 2 of the 3 drugs that usually given to treat this infection. The three drugs used together are called albendazole (ALB), ivermectin (IVM) and diethylcarbamazine (DEC). The usual treatment in Papua New Guinea (PNG) for lymphatic filariasis are DEC and ALB. A combination of these 3 drugs has not been previously used to treat LF.
详细描述
This study will determine whether a single dose of the triple drug regimen of DEC/Iver/Alb is non-inferior to annual treatments with DEC/Alb in inducing sustained clearance of Mf in LF infected subjects (>50 Mf/ml) at 36 months post-treatment. This study also tests the hypothesis that single dose of triple drug is super in sustained clearance of microfilariae compared to single dose of DEC/ALB.
There will be 3 treatment arms as follows:
- The comparator (standard treatment) DEC 6 mg/kg + Alb 400 mg administered annually (at 0, 12, and 24 months).
- DEC 6 mg/kg + Alb 400 mg given once
- DEC 6 mg/kg + Alb 400 mg + Iver 200 µg/kg administered once only at the beginning of the RCT (0 month).
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Men and women 18-65 years
- •>50 mf/ml in finger stick blood samples
- •Willing to give informed consent
排除标准
- •Prior treatment for LF within last 5 years
- •Pregnant (do pregnancy test)
- •Hemoglobin < 7 g/dl
- •permanent disability, serious medical illness that prevents or impedes study participation and/or comprehension
- •AST/ALT and creatinine > 1.5 upper limit of normal.
- •Urine dipstick with glucose ≥ 2+ and/or protein ≥ 2+
研究组 & 干预措施
standard treatment
Diethylcarbamazine 6 mg/kg + Albendazole 400 mg administered annually (at 0, 12, and 24 months).
干预措施: Diethylcarbamazine (Drug)
standard treatment
Diethylcarbamazine 6 mg/kg + Albendazole 400 mg administered annually (at 0, 12, and 24 months).
干预措施: Albendazole (Drug)
DEC 6 mg/kg + Alb 400 mg x 1
Diethylcarbamazine 6 mg/kg + Albendazole 400 mg given once
干预措施: Diethylcarbamazine (Drug)
DEC 6 mg/kg + Alb 400 mg x 1
Diethylcarbamazine 6 mg/kg + Albendazole 400 mg given once
干预措施: Albendazole (Drug)
DEC + ALB + IVM
Diethylcarbamazine 6 mg/kg + Albendazole 400 mg + Ivermectin 200 µg/kg administered once only at the beginning of the RCT (0 month)
干预措施: Diethylcarbamazine (Drug)
DEC + ALB + IVM
Diethylcarbamazine 6 mg/kg + Albendazole 400 mg + Ivermectin 200 µg/kg administered once only at the beginning of the RCT (0 month)
干预措施: Albendazole (Drug)
DEC + ALB + IVM
Diethylcarbamazine 6 mg/kg + Albendazole 400 mg + Ivermectin 200 µg/kg administered once only at the beginning of the RCT (0 month)
干预措施: Ivermectin (Drug)
结局指标
主要结局
Percentage of subjects with total clearance of in Wuchereria bancrofti (Wb) microfilaria (mf)
时间窗: at 36 months
次要结局
- Percent of subjects who become circulating antigen negative at 24 months and 36 months after the beginning of the study(24 months and 36 months)
- Percentage of subjects with total clearance of Mf at 24 months.(24 months)
- Percent reduction in W. bancrofti antigen levels compared to baseline measured at 24 and 36 months(24 months and 36 months)
研究者
Christopher L. King, MD, PhD
Professor/PI
University Hospitals Cleveland Medical Center