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.
Study Overview
Status
Detailed Description
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.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: NOLAN HASSOLD
- Phone Number: 01 42 35 61 07
- Email: nolan.hassold@ch-stdenis.fr
Study Contact Backup
- Name: Marion PARISEY
- Phone Number: 01 42 35 61 40
- Email: marion.parisey@ch-stdenis.fr
Study Locations
-
-
France
-
Saint-Denis, France, France
- Recruiting
- Centre Hospitalier de Saint-Denis
-
Contact:
- Nolan HASSOLD
- Phone Number: 0142356208
- Email: coordination.rechercheclinique@ghtpdfr.fr
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
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.
Description
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.
Study Plan
How is the study designed?
Design Details
- Observational Models: COHORT
- Time Perspectives: RETROSPECTIVE
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Measure: Frequency of ACT monotherapy use in patients with severe Plasmodium falciparum malaria
Time Frame: 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)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Measure: Treatment success with ACT compared with intravenous artesunate
Time Frame: 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
Time Frame: Day 28
|
All-cause mortality within 28 days after diagnosis/hospitalization for severe Plasmodium falciparum malaria. |
Day 28
|
Collaborators and Investigators
Publications and helpful links
General Publications
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 0124_SMIT_PAPERS
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
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.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.