Effectiveness and Safety of Artemether + Lumefantrine and Dihydroartemisinin + Piperaquine for Treating Malaria
Effectiveness and Safety of Artemether + Lumefantrine and Dihydroartemisinin + Piperaquine for the Treatment of Uncomplicated Malaria in Guinea-Bissau
Objective: to measure the effectiveness and safety of (artemether-lumefantrine) AL and (dihydroartemisinin-piperaquine) DP in patients (> 6 months) suffering from uncomplicated P. falciparum malaria.
Patients coming to Bandim Health Center will, if accepting, be randomised to study-arm. Medication will be provided and first dose given. Patients will be followed-up on day 7, 14, 28, and 42 with clinical evaluation, malaria film and filter-paper blood-sample for polumerase chain reaction (PCR) on re-appearing parasites. On day 21 and 35 a telephone-interview will be performed.
Primary out-come: adequate clinical and parasitological response rate on day 42. Secondary out-comes: safety, re-infection vs recrudescence, and haemoglobin on day 42.
調査の概要
状態
詳細な説明
To objective of the study:
- To measure the efficacy and safety of AL and DP in children for treating uncomplicated P. falciparum malaria.
- To determine the capacity of each drug combination to protect against re-infection.
- To differentiate recrudescence from re-infections using PCR based methods
- To determine haemoglobin values on days 0 and 42
- To determine genetic polymorphisms in P. falciparum causing reparasitaemia. Study design This will be an open label, randomized, non inferiority trial conducted at the Bandim Health Centre, Guinea-Bissau. Patients with uncomplicated malaria who meet study inclusion criteria will be enrolled, randomised to treatment with either AL or DP. Medication will be provided and first dose given at the health centre.
Efficacy and safety evaluation Treatment outcomes will be early treatment failure, late clinical failure, late parasitological failure or adequate clinical and parasitological response as defined by the WHO. All will be asked routinely about previous symptoms and about symptoms that have emerged since the previous follow up visit. All adverse events will be recorded in the case record forms.
100µL of blood will be collected on Whatman 3MM filter-paper using a capillary tube on day 0, 7, 14, 28,and 42 and whenever re-parasitaemia is detected. Filter-papers will be dried and then placed inside separate sealed plastic bags.
In order to differentiate recrudescence from a re-infection genotyping using sequential analysis of pf-glurp, pfmsp1 and pfmsp2 will be done. Drug concentrations will be assessed on the week prior to re-parasitaemia. Haemoglobin concentration will be determined on day 0, 3 and 42 using a haemocueTM.
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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Bissau Codex
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Bissau、Bissau Codex、ギニアビサウ
- Bandim Health Centre
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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 detected by microscopy.
- Parasitemia of 1.000-200.000/µl asexual forms.
- Axillary temperature ≥37.5 ˚C or a history of fever within 24 hours.
- Ability to swallow oral medication.
- Ability and willingness to comply with the study protocol for the duration of the study and to comply with the study visit schedule.
- Informed consent
Exclusion Criteria:
- Signs or symptoms of severe malaria
- Presence of general danger signs in children under 5
- Presence of severe malnutrition.
- Any evidence of chronic disease or acute infection other than malaria.
- Regular medication which may interfere with antimalarial pharmacokinetics.
- History of hypersensitivity reactions or contraindications to AL, DP or quinine.
- Domicile outside the study area.
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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実験的:dihydroartemisinin-piperaquine
First dose will be given supervised. The rest will be provided and the parents should take it at home. Dihydroartemisinin-piperaquine dosing as recommended by manufacturer |
Dihydroartemisinin-piperaquine is given as recommended by manufacturer and compared to the Artemether-lumefantrine group.
他の名前:
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アクティブコンパレータ:artemether-lumefantrine
First dose will be given supervised. The rest will be provided and the patients should take it at home. Artemether-lumefantrine dosing as recommended by manufacturer |
Artemether-Lumefantrine is given as recommended by manufacturer
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 |
---|---|---|
Adequate clinical and parasitological response rate at day 42
時間枠:Day 42
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Cumulative percentages of children having successful treatment on day 42.
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Day 42
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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 |
---|---|---|
re-infection vs recrudescence
時間枠:Day 42
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Cumulative re-infection and recrudescence rates
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Day 42
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Haemoglobin level
時間枠:Day 42
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Haemoglobin measured on day 42
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Day 42
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協力者と研究者
スポンサー
研究記録日
主要日程の研究
研究開始 (実際)
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 (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
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Dihydroartemisinin-piperaquine 160 mg/20 mg Oral Tabletの臨床試験
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LG Life Sciences完了
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Reata, a wholly owned subsidiary of BiogenAbbVie; Friedreich's Ataxia Research Alliance積極的、募集していない
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Intermountain Health Care, Inc.Merck Sharp & Dohme LLC; Abbott完了
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Laboratorios Silanes S.A. de C.V.募集
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Maastricht University Medical CenterErasmus Medical Center; VieCuri Medical Centreわからない