Efficacy of Artemether/Lumefantrine for the Treatment of Uncomplicated Malaria. (ALE)
Efficacy of Artemether/Lumefantrine for the Treatment of Uncomplicated Plasmodium Falciparum Malaria in Children Five Years After Wide Scale Use of the Drug in Tanzania.
調査の概要
詳細な説明
Artemisinin based combination therapies (ACTs) are currently recommended by the World Health Organization (WHO) as first-line treatment for uncomplicated malaria in all malaria endemic countries including Tanzania, that adopted the policy in 2007. ACTs have proven to be highly efficacious in different parts of the world with different malaria endemicity. Artemisinins clear asexual parasites rapidly and they are also potent against P. falciparum gametocytes, hence reducing disease transmission and spread of drug resistance. Nonetheless, a report in Kenya shows an increase in proportion of patients with parasitaemia on day 1. Most recently, resistance against artemisinins has been confirmed in four countries of South-East Asia, and it may spread to Africa.
In order to safeguard ACTs life span, WHO recommends all suspected malaria cases to be confirmed with parasitological diagnosis, followed by prompt treatment with effective antimalarials. It also emphasizes on the need to conduct efficacy studies for the first and second line antimalarial treatments after every two years so as to be able to detect resistance early on its course. Therefore, based on this notion, this study aimed to assess the therapeutic efficacy of Artemether/Lumefantrine among children with uncomplicated falciparum malaria in Bagamoyo district, five years after its wide scale use in Tanzania.
研究の種類
入学 (実際)
段階
- フェーズ 4
連絡先と場所
研究場所
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Dar es Salaam、タンザニア、P.O Box 65001
- Muhimbili University of Health and Allied Sciences
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- Mono-infection with P. falciparum
- Parasitaemia level of 2000 - 200,000/μL
- Absence of danger signs or signs of severe malaria
- Axillary temperature ≥ 37.5°C or history of fever 24 hours prior to coming to the facility
- Absence of other concomitant infections like pneumonia which can cause fever
- No use of antimalarial drug two weeks prior to the study
- Consent to comply to the protocol.
Exclusion Criteria:
- Presence of general danger signs or signs of severe falciparum malaria
- Severe malnutrition
- Febrile condition due to diseases other than malaria, such as measles, acute lower respiratory infection or other known chronic diseases
- Regular medication which might interfere with antimalarial pharmacokinetics
- History of hypersensitivity reactions or contraindications to any medicine being used in the trial.
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：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：Artemether/lumefantrine
In this single-arm study, patients will be treated with Artemether/lumefantrine, and the first, third and fifth doses of the drug will be given under the direct observation of the health workers.
The patients will be followed-up for 42 days, on day 1, 2, 3, 7, 14, 21, 28 and 42 to assess the efficacy of the drug.
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Blood samples will be collected on blood slides and filter papers for asexual parasites assessment both by microscope and molecular genotyping respectively following treatment with artemether-lumefantrine, to assess its efficacy.
他の名前：
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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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Proportion of patients without parasitaemia on day 42.
時間枠：42 Days
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Proportion of patients without parasitaemia or with new infection as corrected by molecular genotyping on day 42 will be used to calculate the efficacy of the trial medicine.
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42 Days
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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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Plasma lumefantrine concentration
時間枠：7 days and 14 days
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Mean plasma lumefantrine concentration among patients on day 7 and day 14 following treatment with artemether/lumefantrine as a predictor of cure rate.
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7 days and 14 days
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その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Proportional of patients without parasitaemia on day 42
時間枠：42 days
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Proportion of patients without parasitaemia on day 42 as purely assessed by molecular genotyping of all collected samples on this day, differentiate between recrudescence and new infection and use it to calculate the efficacy of the trial medicine.
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42 days
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協力者と研究者
スポンサー
捜査官
- スタディディレクター：Andreas Martensson, PhD、Karolinska Institutet
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
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 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
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
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