Management of Severe Plasmodium Falciparum Malaria With Oral Artemisinin Derivatives (PAPERS)
ACTs could be used as first-line treatment for Plasmodium falciparum malaria without clinical signs of severity but with biological severity criteria.
The study aims to determine the real-world frequency of ACT monotherapy use in cases of P. falciparum malaria with severity criteria, and to compare the treatment success of ACTs with that of artesunate.
調査の概要
詳細な説明
Since 2010, intravenous artesunate has been recommended by the World Health Organization as first-line treatment for severe malaria in adults and children. In France, severe imported malaria represents approximately 10% of imported malaria cases, with Plasmodium falciparum accounting for approximately 85% of cases.
The PAPERS study will retrospectively evaluate clinical practice since 2011 in adult patients diagnosed with Plasmodium falciparum malaria presenting at least one clinico-biological severity criterion.
The main objective is to determine the real-world frequency of ACT monotherapy in patients with severe Plasmodium falciparum malaria.
Secondary objectives are to compare treatment success between ACT and intravenous artesunate, assess non-life-threatening complications, evaluate duration of hospitalization in critical care and conventional wards, and assess Day-28 mortality.
研究の種類
入学 (推定)
連絡先と場所
研究連絡先
- 名前：NOLAN HASSOLD
- 電話番号：01 42 35 61 07
- メール：nolan.hassold@ch-stdenis.fr
研究連絡先のバックアップ
- 名前：Marion PARISEY
- 電話番号：01 42 35 61 40
- メール：marion.parisey@ch-stdenis.fr
研究場所
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France
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Saint-Denis、France、フランス
- 募集
- Centre Hospitalier de Saint-Denis
-
コンタクト：
- Nolan HASSOLD
- 電話番号：0142356208
- メール：coordination.rechercheclinique@ghtpdfr.fr
-
-
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
サンプリング方法
調査対象母集団
The study population will consist of adult patients (aged 18 years and older) diagnosed with Plasmodium falciparum malaria who present at least one clinico-biological severity criterion. Patients under 18 years of age and those who refuse the use of their data for research will be excluded. Participants will be selected from hospital settings where cases of severe malaria are managed, ensuring a real-world representation of patients receiving either ACTs or artesunate.
説明
Inclusion Criteria
- Patients aged 18 years or older.
- Diagnosis of Plasmodium falciparum malaria.
- At least one clinico-biological criterion of severe malaria.
- Hospitalization in a medical intensive care/critical care unit.
- Hospitalization between January 1, 2011 and October 30, 2025.
Exclusion Criteria
- Age <18 years.
- Patient who objects to the use of their data for research.
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
- 観測モデル：COHORT
- 時間の展望：RETROSPECTIVE
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 |
|---|---|---|
|
Measure: Frequency of ACT monotherapy use in patients with severe Plasmodium falciparum malaria
時間枠：At diagnosis / initial treatment (Baseline)
|
Proportion of patients with severe Plasmodium falciparum malaria and at least one clinical or biological severity criterion who received ACT alone as antimalarial treatment at the time of diagnosis (Baseline) |
At diagnosis / initial treatment (Baseline)
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Measure: Treatment success with ACT compared with intravenous artesunate
時間枠：Day 3, Day 7 and Day 28 after treatment initiation.
|
Comparison of parasitological outcomes between patients treated with ACT alone and patients treated with intravenous artesunate. Treatment success will be assessed based on the results of parasitological examinations, recorded as positive or negative, on Days 3, 7, and 28 after treatment initiation. Treatment success will be defined as a negative parasitological examination. |
Day 3, Day 7 and Day 28 after treatment initiation.
|
|
Measure: 28-day mortality
時間枠：Day 28
|
All-cause mortality within 28 days after diagnosis/hospitalization for severe Plasmodium falciparum malaria. |
Day 28
|
協力者と研究者
出版物と役立つリンク
一般刊行物
- Dondorp A, Nosten F, Stepniewska K, Day N, White N; South East Asian Quinine Artesunate Malaria Trial (SEAQUAMAT) group. Artesunate versus quinine for treatment of severe falciparum malaria: a randomised trial. Lancet. 2005 Aug 27-Sep 2;366(9487):717-25. doi: 10.1016/S0140-6736(05)67176-0.
- Bruneel F, Tubach F, Corne P, Megarbane B, Mira JP, Peytel E, Camus C, Schortgen F, Azoulay E, Cohen Y, Georges H, Meybeck A, Hyvernat H, Trouillet JL, Frenoy E, Nicolet L, Roy C, Durand R, Le Bras J, Wolff M; Severe Imported Malaria in Adults (SIMA) Study Group. Severe imported falciparum malaria: a cohort study in 400 critically ill adults. PLoS One. 2010 Oct 8;5(10):e13236. doi: 10.1371/journal.pone.0013236.
- Mornand P, Legros F, Verret C, et al. Paludisme grave d'importation chez l'enfant en France : étude nationale rétrospective de 1996 à 2005. Médecine Tropicale. 2008;68(4):401.
- Bruneel F, Raffetin A, Corne P, Llitjos JF, Mourvillier B, Argaud L, Wolff M, Laurent V, Jaureguiberry S. Management of severe imported malaria in adults. Med Mal Infect. 2020 Mar;50(2):213-225. doi: 10.1016/j.medmal.2018.08.003. Epub 2018 Sep 25.
- HCSP. Place de l'artésunate injectable dans le traitement du paludisme grave de l'adulte et de l'enfant. 2013.
研究記録日
主要日程の研究
研究開始 (実際)
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
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
Individual participant data (IPD) will not be made available to other researchers. The study data will be pseudonymized and stored in a secure database with restricted access. The correspondence file linking study codes to patient identities will not be transmitted to the sponsor.
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
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。