PACTR201906665550709尚未招募未知
Safety and efficacy of combination therapy with ivermectin, diethylcarbamazine, and albendazole (IDA) for individuals with onchocerciasis
适应症
试验速览
- 阶段
- 未知
- 状态
- 尚未招募
- 入组人数
- 300
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 19 Year(s) 至 44 Year(s)（—）
- 性别
- All
入选标准
- •1.Men and women 16 – 70 years (at the time of enrollment; ±2 years) of age previously enrolled in the Part 1 study and residing in the area of the study.
- •2.Participants must have at least 1 palpable subcutaneous nodule (onchocercoma).
- •3.Participants with baseline skin Mf counts = 3Mf/mg at the time of enrollment into the Part 1 study (Part I, see above).
排除标准
- •1.Pregnant and breastfeeding mothers within 1 month of giving birth
- •2.Severe eye disease at baseline including uveitis, severe glaucoma, , severe keratitis, and/or cataracts that interfere with visualization of the posterior segment of the eye as well as the list of ocular diseases as outlined below Individuals who are excluded with significant ocular disease will be referred to appropriate ophthalmological care in a health facility (the district hospital) or the any other health facility in Ghana, where affected subjects will obtain appropriate care (University hospital or private ophthalmologist). All ocular disease exclusion criteria apply to either eye. Bilateral disease is not necessary to exclude a participant. A participant will be excluded if any of the criteria are met for one eye.
- •a.-j. Ocular exclusion criteria listed in full in the protocol (not possible to list here due to word limit).
- •3.Significant comorbidities such as renal insufficiency, liver failure, or any other acute or chronic illness identified by study clinicians and investigators that interferes with the participant’s ability to go to school or work or perform routine household chores.
- •4.Prior allergic / hypersensitivity reactions or intolerance to IVM, albendazole, or DEC.
- •5.Treatment with IVM outside of the study after the pre-treatment clearing dose provided in the Part I study.
- •6.>5 motile Mf in the anterior chamber in either eye at the time of enrollment (six months after pre-treatment with IVM).
- •7.Any Mf identified in the posterior segment of the eye at the time of enrollment (six months after pre-treatment with IVM).
- •8.Any other condition identified by study clinicians or investigators that may preclude participation in the study.
研究者
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