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