An observational study in Malaria, Falciparum, Plasmodium Falciparum and Artemisinins, sponsored by Centre Hospitalier de Saint-Denis. Recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-13.
Sponsored by Centre Hospitalier de Saint-Denis · Observational
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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.
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.
456 studies on the registry are indexed under Malaria, Falciparum; 38 are open to participants now.
This study's planned enrollment of 1,000 is above the median of 579 across 64 observational studies indexed under Malaria, Falciparum.
Browse Malaria, Falciparum studies →Centre Hospitalier de Saint-Denis is the lead sponsor of 46 studies on the registry; 20 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
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Exclusion Criteria
Measure: Frequency of ACT monotherapy use in patients with severe Plasmodium falciparum malaria
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)
Time frame: At diagnosis / initial treatment (Baseline)
Measure: Treatment success with ACT compared with intravenous artesunate
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.
Time frame: Day 3, Day 7 and Day 28 after treatment initiation.
Measure: 28-day mortality
All-cause mortality within 28 days after diagnosis/hospitalization for severe Plasmodium falciparum malaria.
Time frame: Day 28
Plan to share: No — 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.
Started Jul 2026 (actual). Primary completion is estimated for Jan 2027, 5 months after the start.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Centre Hospitalier de Saint-Denis