Palustar: Very Severe Malaria Treated by Intravenous Artesunate
Study Details
Study Description
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.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Detailed Description
See Brief Summary
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Group intravenous artesunate (around 300 patients) Period 2011-2019 |
Other: None (Observational study Group intravenous artesunate)
Retrospective descriptive study of Group intravenous artesunate
|
Group intravenous quinine (around 300 patients) Period 2000-2010 |
Other: None (Observational study Group intravenous quinine)
Retrospective descriptive study of Group intravenous quinine
|
Outcome Measures
Primary Outcome Measures
- Mortality rate in the Group intravenous artesunate [At hospital discharge, an average of 1 month]
Mortality reported as a mortality rate (%)
Secondary Outcome Measures
- Mortality rates in the Group artesunate and Group quinine [At hospital discharge, an average of 1 month]
Mortality reported as a mortality rate (%)
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Fabrice BRUNEEL | Le Chesnay | Île-de-France | France | 78150 |
Sponsors and Collaborators
- Dr Fabrice BRUNEEL
Investigators
- Principal Investigator: Fabrice BRUNEEL, MD, Versailles Hospital Center
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- P20/18_Palustar