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.
調査の概要
研究の種類
入学 (推定)
段階
- フェーズ 4
連絡先と場所
研究場所
-
-
-
London、イギリス、WC1E 7HT
- London School of Hygiene & Tropical Medicine
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コンタクト：
- Robert T Jones, PhD
- 電話番号：+447745845880
- メール：robert.jones@lshtm.ac.uk
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主任研究者：
- Anna Last, PhD
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-
参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：基礎科学
- 割り当て：なし
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：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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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Musca sorbens larvae surviving to adulthood
時間枠：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
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Concentration of ivermectin in faeces
時間枠：Days 1, 2, 3, 4, 5, 10 and 30 post treatment
|
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
時間枠：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
時間枠：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
時間枠：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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協力者と研究者
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
キーワード
追加の関連 MeSH 用語
その他の研究ID番号
- 32885
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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