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治験 NCT07145736 (EKAIO)（対象：オンコセルカ症、回虫感染症、Trichuris Trichiura; Infection、鉤虫感染症、疥癬）は募集中です。詳細は治験レーダーのタイル表示と AI 発見ツールで確認するか、ここで質問してください。 | ||
フィルター基準に一致する試験が1件見つかりました
タイル表示
Moxidectin Versus Ivermectin as Mass Drug Administration for the Control of Onchocerciasis and Other Neglected Tropical Diseases (EKAIO) 第IV相・フェーズ4 52,000
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治験番号 NCT07145736 (EKAIO) は オンコセルカ症、回虫感染症、Trichuris Trichiura; Infection、鉤虫感染症、疥癬 に関する その他 の研究で、第IV相・フェーズ4 介入研究 臨床試験 です。現在は 募集中 で、2025年8月4日 から開始しています。52,000 名の参加者 の募集が計画されています。この試験は Kirby Institute によって主導され、2029年6月30日 に完了予定です。ClinicalTrials.gov からの最新更新日は 2025年11月21日 です。
概要
This clinical trial compares two treatments - ivermectin and moxidectin - to learn which is better at reducing the proportion of people with onchocerciasis (river blindness) when given through mass drug administration (MDA) in Angola. Both drugs are approved by the United States Food and Drug Administration (FDA) to treat this disease. The study also explores how these treatments affect other infections common in the...もっと見る
公式タイトル
Moxidectin Versus Ivermectin as Mass Drug Administration for the Control of Onchocerciasis and Other Neglected Tropical Diseases: A Cluster-randomised Trial
疾患名
オンコセルカ症回虫感染症Trichuris Trichiura; Infection鉤虫感染症疥癬その他の研究識別子
- EKAIO
- KirbyI
NCT番号
開始日
2025-08-04
最終更新日
2025-11-21
終了予定日
2029-06-30
目標参加者数
52,000
試験の種類
介入研究
治験の相・段階
第IV相・フェーズ4
状況
募集中
主目的
その他
割付方法
無作為化
介入モデル
並行割当
盲検化
単盲検
群（アーム）／介入
| 参加グループ/群 | 介入/治療法 |
|---|---|
実験的Moxidectin Single oral dose of moxidectin treatment 8 mg (4 tablets of 2 mg of moxidectin), once per year | Moxidectin 2 mg tablets |
実薬対照薬Ivermectin Single oral dose of ivermectin treatment with approximately 150 µg/kg determined based on height (between 1 and 4 tablets of 3 mg of ivermectin), once per year | Ivermectin 3 mg tablets |
主要評価項目
副次評価項目
| 評価指標 | 指標の説明 | 時間枠 |
|---|---|---|
Prevalence of Onchocerca volvulus microfilariae | Prevalence of O. volvulus microfilariae at 36 months in skin snips, the marker most likely to show change in the shorter term as demonstrated by the therapeutic trials | 36 months after the first intervention |
| 評価指標 | 指標の説明 | 時間枠 |
|---|---|---|
Prevalence of O. volvulus microfilaria/mg skin | 12, 24 and 36 months after the first intervention | |
Microfilariae density (mean, median) | 12, 24 and 36 months after the first intervention | |
Prevalence of nodules | 12, 24 and 36 months after the first intervention | |
Prevalence of onchocerciasis skin disease | 12, 24 and 36 months after the first intervention | |
Proportion of black flies with infective O. volvulus larvae | Infection assessed based on all 3 are markers recommended by WHO to define population-level elimination | 12, 24 and 36 months after the first intervention |
Prevalence of anti-Ov-16 | 12, 24 and 36 months after the first intervention | |
Prevalence of Ascaris lumbricoides | Measured through qPCR | 12, 24 and 36 months after the first intervention |
Intensity of Ascaris lumbricoides infection | Measured through qPCR | 12, 24 and 36 months after the first intervention |
Prevalence of Trichuris trichiura | Measured through qPCR | 12, 24 and 36 months after the first intervention |
Intensity of Trichuris trichiura infection | Measured through qPCR | Baseline and 12, 24 and 36 months after the first intervention |
Prevalence of hookworm | Measured through qPCR | 12, 24 and 36 months after the first intervention |
Intensity of hookworm infection | Measured through qPCR | 12, 24 and 36 months after the first intervention |
Prevalence of Strongyloides stercoralis | Measured through qPCR | 12, 24 and 36 months after the first intervention |
Intensity of Strongyloides stercoralis infection | Measured through qPCR | 12, 24 and 36 months after the first intervention |
Prevalence of scabies/impetigo | 12, 24 and 36 months after the first intervention |
参加アシスタント
適格基準
対象年齢
小児, 成人, 高齢者
試験の最低年齢
5 Years
対象性別
全て
健康なボランティアを受け入れる
はい
- Male or female children and adults
- Residents in the villages selected for MDA treatment
- Arm 1 (ivermectin): children under the age of 5 and/or under 90 cm of height
- Arm 2 (moxidectin): children under the age of 12 years (who will receive ivermectin if they are at least 90 cm in height/5 years of age and above).
- Arm 1 (ivermectin): Women breast-feeding babies under 45 days of age
- Arm 2 (moxidectin): All breastfeeding women (who will be offered ivermectin if their infants is at least 45 days old)
- Know allergy to ivermectin or moxidectin
- Attending other clinical trials during the study
- Pregnant
- Arm 2 (moxidectin): Women planning to become pregnant in the 3 months post-treatment
- Refusal to receive one or both study drugs, i.e. participants in villages allocated to receive moxidectin who refuse to receive moxidectin will be given the option to receive ivermectin; if they refuse to receive both drugs they will be excluded from the MDA altogether
- Has an illness that makes them too sick or weak to get out of bed
- Currently hospitalized
Kirby Institute試験中央連絡先
連絡先: Susana V Nery, PhD, +61467076047, [email protected]
連絡先: Marta S Palmeirim, PhD, +351916563622, [email protected]
1 1カ国の場所
Bíe Province
Villages in Andulo and Nharea Municipalities, Andulo, Bíe Province, Angola
Marta Palmeirim, PhD, 連絡先, +351 916 563 622, [email protected]
募集中