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.
研究概览
详细说明
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.
研究类型
注册 (估计的)
联系人和位置
学习联系方式
- 姓名：NOLAN HASSOLD
- 电话号码：01 42 35 61 07
- 邮箱：nolan.hassold@ch-stdenis.fr
研究联系人备份
- 姓名：Marion PARISEY
- 电话号码：01 42 35 61 40
- 邮箱：marion.parisey@ch-stdenis.fr
学习地点
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France
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Saint-Denis、France、法国
- 招聘中
- Centre Hospitalier de Saint-Denis
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接触：
- Nolan HASSOLD
- 电话号码：0142356208
- 邮箱：coordination.rechercheclinique@ghtpdfr.fr
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-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
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.
描述
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.
学习计划
研究是如何设计的？
设计细节
- 观测模型：COHORT
- 时间观点：RETROSPECTIVE
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Measure: Frequency of ACT monotherapy use in patients with severe Plasmodium falciparum malaria
大体时间：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)
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Measure: Treatment success with ACT compared with intravenous artesunate
大体时间：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.
|
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Measure: 28-day mortality
大体时间：Day 28
|
All-cause mortality within 28 days after diagnosis/hospitalization for severe Plasmodium falciparum malaria. |
Day 28
|
合作者和调查者
出版物和有用的链接
一般刊物
- 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.
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
IPD 计划说明
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.
药物和器械信息、研究文件
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研究美国 FDA 监管的设备产品
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