Last reviewed · How we verify
NCT04516317: Palustar
Very Severe Malaria Treated by Intravenous Artesunate
trial testing None (Observational study Group intravenous artesunate) in Severe Malaria in 578 participants. Completed in 22 March 2022.
15 March 2022
Quick facts
| Lead sponsor | Dr Fabrice BRUNEEL |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 578 |
| Start date | 10 August 2020 |
| Primary completion | 15 March 2022 |
| Estimated completion | 22 March 2022 |
| Sites | 1 location across France |
Drugs / interventions tested
- None (Observational study Group intravenous artesunate)
- None (Observational study Group intravenous quinine)
Conditions studied
- Severe Malaria — all drugs for Severe Malaria →
Sponsor
Dr Fabrice BRUNEEL
Who can join
18 and older, any sex, with Severe Malaria. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
In endemic areas, Plasmodium falciparum malaria exacts a huge public health toll, causing close to half a million deaths each year. In non-endemic industrialized areas, imported malaria may develop. In France, around 5000 imported cases occured annually, including 10-15% of severe malaria. The criteria for defining severe malaria in endemic areas are established by the World Health Organization (WHO), and have been adjusted for severe imported malaria. In France, in order to optimize management, severe imported malaria is separated into two groups: very severe malaria (VSM) and less severe malaria (LSM). Briefly VSM included coma and/or shock and/or respiratory failure and/or acidosis and/or hyperlactatemia and/or death during hospitalization. In France, severe imported malaria is treated with intravenous artesunate. Little is known about the management of imported VSM in the ICU with intravenous artesunate. In a French national multicentric retrospective frame, the main objective of the present study is to describe in detail: epidemiology, management, outcome and prognostic of very severe imported malaria treated with intravenous artesunate during the period 2011-2019. The second objective is to retrospectively compare two groups : VSM treated with intravenous artesunate in the ICU during 2011-2019 versus VSM treated with intravenous quinine in the ICU during 2000-2010.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT04516317
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Severe Malaria
Currently open trials in the same condition.
- NCT06624631 — PDMC Implementation Trial in Kenya · Phase 4 · recruiting
- NCT06601712 — Post-discharge Malaria Chemoprevention Implementation Trial in Benin · Phase 4 · recruiting
- NCT05711485 — Platelet-Directed Whole Blood Transfusion Strategy for Malaria · NA · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04516317 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Dr Fabrice BRUNEEL
- Last refreshed: 24 March 2022
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04516317.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing