Trial of Rifampin and Azithromycin for Treatment of Endosymbiotic Bacteria (Wolbachia) in Onchocerca Volvulus in Guatemala
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Eliminating Wolbachia endobacteria present in O. volvulus worms after 9 months
研究概览
简要总结
The purpose of this study is to determine whether rifampin and/or azithromycin are effective in the treatment of river blindness (onchocerciasis).
详细描述
Mass treatment with ivermectin (Mectizan, Merck & Co) is the mainstay of the current efforts to control onchocerciasis, but the drug is not lethal to adult Onchocerca volvulus parasites. Wolbachia, an endosymbiotic bacterium necessary for the fecundity of O. volvulus, can be eradicated with four-six week courses of doxycycline, but this cannot be implemented in current mass drug administration programs. The purpose of this study is to evaluate if a shorter course (five days) with antibiotics that could be used in children and potentially pregnant women would likewise be effective.
Guatemalan patients with onchocercal nodules will be enrolled in an open label trial with four treatment groups: Group A (rifampin 20 mg/kg by mouth [po; maximum 600 mg/day]); B (azithromycin 12 mg/kg po [maximum 500 mg/day]); C (combination of rifampin 20 mg/kg po [maximum 600 mg/day] and azithromycin 12 mg/kg po [maximum 500 mg/day]); D (control group, multivitamin). At the end of the five day treatment course all participants will receive a single dose of ivermectin (150 mcg/kg).
Nodulectomies will be performed 9 months after treatment and the O. volvulus will be analyzed by immunohistochemical staining specific for Wolbachia.
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
- 5 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males and non-pregnant/non lactating females >5 years of age
- •One onchocercal nodule in an anatomical position where it can be easily removed surgically
排除标准
- •Pregnancy (based on urine pregnancy test)
- •Breast-feeding
- •Women taking oral contraceptives
- •Allergy or other adverse reaction to either medication
- •Use of other medications that might interact with rifampin
- •Clinical evidence of liver disease (jaundice, swollen abdomen)
- •Clinical evidence of chronic disease/alcoholism
结局指标
主要结局
Eliminating Wolbachia endobacteria present in O. volvulus worms after 9 months
次要结局
- Elimination of microfilaria in skin snips and histological examination of worms after 9 months