Evaluation of the Impact of Oral Ivermectin on Musca Sorbens Flies, Putative Vector of Trachoma (IVERMUSC)
Evaluation of the Impact of Oral Ivermectin (150 Micrograms/kg) on Musca Sorbens, the Putative Vector of Trachoma
Trachoma is caused by repeated Chlamydia trachomatis infection in the eye. Routes of infection include close person-to-person contact and contaminated clothing. In addition, the bazaar fly Musca sorbens has been implicated in transmission. These flies frequently visit the faces of children and have been found positive for C. trachomatis, which may be transferred from the body of the flies or their regurgitated or defecated material.
This study aims to give recruited healthy volunteers a safe dose of oral ivermectin. Their faeces will be collected over subsequent days to determine whether ivermectin excreted from the body results in faecal concentrations that are high enough to prevent emergence of M. sorbens developing in faeces. It will also quantify ivermectin concentrations in tears secretions and faecal samples for up to 30 days post-treatment.
研究概览
研究类型
注册 (估计的)
阶段
- 第四阶段
联系人和位置
学习地点
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London、英国、WC1E 7HT
- London School of Hygiene & Tropical Medicine
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接触：
- Robert T Jones, PhD
- 电话号码：+447745845880
- 邮箱：robert.jones@lshtm.ac.uk
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首席研究员：
- Anna Last, PhD
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参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
描述
Inclusion Criteria:
- Able and willing to give fully informed consent
- Able to understand and comply with the study procedures
- Able to produce a stool on most days
- Consider themselves to be in good general health
- Aged 18 to 65 years
Exclusion Criteria:
- Suspected or known to be sensitive or allergic to ivermectin
- Women who are pregnant, nursing or intending to become pregnant
- Aware of having any neurological disorders or recent history of seizures
- History of travel to a region endemic for Loa loa.
- Currently taking acenocoumarol, warfarin or levimasole
学习计划
研究是如何设计的？
设计细节
- 主要用途：基础科学
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：Ivermectin treatment
Participants to receive safe oral dose of ivermectin
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Oral dose of ivermectin (150 micrograms/kg)
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Musca sorbens larvae surviving to adulthood
大体时间：Days 1, 2, 3, 4, 5, 10 and 30 post treatment
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The difference in the mean number of Musca sorbens larvae surviving to adulthood in faecal samples collected at each post-treatment time point compared to pre-treatment samples.
The treatment effect will be estimated separately at each time point.
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Days 1, 2, 3, 4, 5, 10 and 30 post treatment
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Concentration of ivermectin in faeces
大体时间：Days 1, 2, 3, 4, 5, 10 and 30 post treatment
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The mean concentration of ivermectin in faecal samples (ng/g) and tear samples (ng/mL) at baseline and at each post-treatment time point.
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Days 1, 2, 3, 4, 5, 10 and 30 post treatment
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First oviposition event
大体时间：Days 1, 2, 3, 4, 5, 10 and 30 post treatment
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The time from presentation of each faecal sample to the first oviposition event by Musca sorbens at baseline and each post-treatment time point.
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Days 1, 2, 3, 4, 5, 10 and 30 post treatment
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Behvioural response
大体时间：Days 1, 2, 3, 4, 5, 10 and 30 post treatment
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Observed behavioural response(s) of adult female Musca sorbens when presented with faecal samples at baseline and each post-treatment time point.
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Days 1, 2, 3, 4, 5, 10 and 30 post treatment
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Adult fly survival
大体时间：Each time pointDays 1, 2, 3, 4, 5, 10 and 30 post treatment
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The survival of adult female Musca sorbens when presented with faecal samples collected at baseline and each post-treatment time point, measured as time to death.
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Each time pointDays 1, 2, 3, 4, 5, 10 and 30 post treatment
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合作者和调查者
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
关键字
其他相关的 MeSH 术语
其他研究编号
- 32885
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
IPD 计划说明
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
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