Status:
COMPLETED
Very Severe Malaria Treated by Intravenous Artesunate
Lead Sponsor:
Dr Fabrice BRUNEEL
Conditions:
Severe Malaria
Eligibility:
All Genders
18+ years
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. I...
Detailed Description
See Brief Summary
Eligibility Criteria
Inclusion
- 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
- Less than 18 year-old at the time of inclusion OR
- Opposition to participate in the present study
Key Trial Info
Start Date :
August 10 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
March 22 2022
Estimated Enrollment :
578 Patients enrolled
Trial Details
Trial ID
NCT04516317
Start Date
August 10 2020
End Date
March 22 2022
Last Update
March 24 2022
Active Locations (1)
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1
Fabrice BRUNEEL
Le Chesnay, Île-de-France Region, France, 78150