Loiasis Cross-reactive Antigenemia and Treatment-related Adverse Events
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 41
- 试验地点
- 1
- 主要终点
- Cross-reactive Antigenemia
研究概览
简要总结
This study seeks to determine which Loa loa antigens are released into circulation when infected individuals are treated with ivermectin.
详细描述
A cohort of up to 50 participants with Loa loa microfilarial levels between 5,000 and 18,000 per ml/blood will be treated with ivermectin in an inpatient setting. Participants will be monitored for treatment-related adverse events for seven days post-treatment, and will have blood drawn on days 0, 1, 2, 3, and 7 post-treatment to assess for microfilarial load, cytokine, and antigen levels.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Loa loa blood microfilariae of between 5,000 - 18,000 per mL
排除标准
- •known allergy to ivermectin; severe comorbidities
研究组 & 干预措施
Ivermectin
All eligible participants received a single dose (150 ug/kg) ivermectin by mouth
干预措施: Ivermectin (Drug)
结局指标
主要结局
Cross-reactive Antigenemia
时间窗: 7 days
N of participants with detectable Loa loa antigens in sera that cross-react with diagnostic tests for lymphatic filariasis (Filariasis Test Strip) on either day 1, 2, 3, or 7 post-treatment
次要结局
未报告次要终点