Artemisia Annua Infusion for the Treatment of Asymptomatic Plasmodium Falciparum Infection (ART-CT001)
Clinical Assessment of the Safety and Efficacy of Artemisia Annua Infusion Preparation for the Treatment of Asymptomatic Plasmodium Falciparum Infection in Semi-immune Adults in Gabon
The goal of this clinical trial is to determine whether Artemisia annua dried leaves, used as an infusion, can treat individuals with malaria parasites but no symptoms. The main question it aims to answer is:
Can Artemisia annua infusion be used to treat malaria?
Researchers will compare those receiving Artemisia annua infusion with those receiving an infusion of Centaurii herba (which has no effect on malaria parasites) to see whether all individuals treated with Artemisia annua infusion are cured, which should not be the case for those receiving Centaurii herba infusion.
Participants will
- drink Artemisia annua infusion over seven days (three days at our research centre and four days at their home
- visit the research centre once a week for three weeks after treatment for one month for safety reasons
調査の概要
詳細な説明
For safety reasons, participants will be followed up daily for malaria-like symptoms and parasite counts until the end of treatment. Indeed, if they are not free of parasites after seven days of treatment, they will receive rescue treatment, which is the WHO-recommended malaria treatment.
Similarly, if the number of parasites in their blood increases or they develop malaria-like symptoms during treatment, they will receive rescue treatment.
研究の種類
入学 (推定)
段階
- フェーズ 1
連絡先と場所
研究連絡先
- 名前：Jean Claude Dejon Agobé, MD
- 電話番号：0024177989191
- メール：jcagobe@cermel.org
研究場所
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Gabon
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Lambaréné、Gabon、ガボン、BP: 242
- Centre de Recherches Médicales de Lambaréné
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コンタクト：
- Jean Claude Dejon Agobé, MD, PhD
- 電話番号：0024177989191
- メール：jcagobe@cermel.org
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コンタクト：
- Christian Chassem Lapue, MD
- 電話番号：0024177989191
- メール：christian.chassem@cermel.org
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主任研究者：
- Jean Claude Dejon Agobé, MD, PhD
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副調査官：
- Christian Chassem Lapue, MD
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-
参加基準
適格基準
就学可能な年齢
- 大人
健康ボランティアの受け入れ
説明
Inclusion Criteria:
- Age: 18 to 45 years
- Absence of fever (body temperature <37.5ºC axillary or <38.0°C oral, rectal or tympanic temperature)
- Asymptomatic P. falciparum infection with parasitemia between 500 and 2,000 asexual P. falciparum parasites per μl of blood
- Have been living in an endemic area for at least 5 years.
- Written informed consent from the participant
- Residence in the vicinity of the study centre
- Willingness to comply with the follow-up schedule
Exclusion Criteria:
- History of fever over the last 72 hours
- Non-Plasmodium falciparum infection
- Intake of any antimalarial drug or antibiotic with antimalarial activity within the previous 28 days and/or after half-life time
- Presence of signs and symptoms related by the medical doctor to malaria
- Known history or evidence of clinically significant medical disorders
- Severe malnutrition
- Haemoglobin concentration <7 g/dL
- Known hypersensitivity and contraindications to any study medication
- Pregnancy or lactation
- Participation in other interventional studies
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：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- 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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プラセボコンパレーター：コントロールアーム
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The research team will prepare one litre of 'Herba Centaurii' infusion every morning, which will be given to the participants in three splits every 8 hours, under the supervision of the research team for seven consecutive days.
他の名前：
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実験的：Artemisia arm
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Dried Artemisia annua leaves will be used to prepare an infusion by adding 5 mg of dried leaves to 1 litre of boiled water.
The mixture will be left to stand for 15 minutes, then stirred and strained before being administered to the participant.
Participants will receive 1 litre of this infusion (prepared each morning) per day for seven consecutive days.
The research team will administer the daily dose in three splits at 8-hour intervals.
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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 |
|---|---|---|
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Number of participants in whom the parasitaemia was cleared
時間枠：On day 7 from the first day of treatment
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No parasites detected in the thick blood smear (microscopic method)
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On day 7 from the first day of treatment
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Number of participants cured
時間枠：From the last day of treatment (day 7) to the end of the follow-up period on day 28
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Defined as the absence of Plasmodium infection (including reinfections) following treatment, as determined by microscopy and adjusted by PCR, in the per-protocol and intention-to-treat populations.
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From the last day of treatment (day 7) to the end of the follow-up period on day 28
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Number of adverse events
時間枠：From the first day of treatment (enrolment) to the end of the treatment period on day 7
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Types, proportions, severity, and causality of adverse events will be recorded as measures of tolerability and safety
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From the first day of treatment (enrolment) to the end of the treatment period on day 7
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協力者と研究者
捜査官
- スタディチェア：Steffen Borrmann, Prof.、Institut für Tropenmedizin, Universitätsklinikum Tübingen, Wilhelmstraße 27, 72074 Tübingen, Germany
- スタディチェア：Ayôla Akim Adegnika, Prof.、Centre de Recherches Médicales de Lambaréné
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
その他の研究ID番号
- SRC-2024-04
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?
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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