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Very Severe Malaria Treated by Intravenous Artesunate

Very Severe Malaria Treated by Intravenous Artesunate: Epidemiology, Management, Outcome and Prognostic

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04516317
Acronym
Palustar
Enrollment
578
Registered
2020-08-18
Start date
2020-08-10
Completion date
2022-03-22
Last updated
2022-03-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Severe Malaria

Keywords

Severe Malaria, Artesunate, Critical Care, Quinine

Brief summary

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.

Detailed description

See Brief Summary

Interventions

OTHERNone (Observational study Group intravenous artesunate)

Retrospective descriptive study of Group intravenous artesunate

OTHERNone (Observational study Group intravenous quinine)

Retrospective descriptive study of Group intravenous quinine

Sponsors

Dr Fabrice BRUNEEL
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* More than 18 year-old at the time of inclusion AND * Hospitalization in the ICU AND * For severe imported malaria (Plasmodium falciparum) AND * Very Severe Malaria episode defined during the 72 first hours as : * Neurological failure: Glasgow Coma Scale score\<11 or repeated convulsions and/or * Shock: Systolic Blood Pressure\<80 mmHg despite adequate fluid loading or need for vasoactive drugs and/or * Respiratory distress: Mechanical Ventilation or Non Invasive Ventilation ; or if spontaneous breathing: arterial pO2\<60 mmHg or pulse oxymetry\<92% in room air ; or Respiratory Rate\>32/min and/or * Acidosis: plasma bicarbonate \<15 mmol/l, or pH\<7,35 and/or * Hyperlactatemia \> 5 mmol/l and/or * Death during hospitalization for VSM

Exclusion criteria

* Less than 18 year-old at the time of inclusion OR * Opposition to participate in the present study

Design outcomes

Primary

MeasureTime frameDescription
Mortality rate in the Group intravenous artesunateAt hospital discharge, an average of 1 monthMortality reported as a mortality rate (%)

Secondary

MeasureTime frameDescription
Mortality rates in the Group artesunate and Group quinineAt hospital discharge, an average of 1 monthMortality reported as a mortality rate (%)

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026