Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
578 participants
OBSERVATIONAL
2020-08-10
2022-03-22
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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COHORT
RETROSPECTIVE
Study Groups
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Group intravenous artesunate (around 300 patients)
Period 2011-2019
None (Observational study Group intravenous artesunate)
Retrospective descriptive study of Group intravenous artesunate
Group intravenous quinine (around 300 patients)
Period 2000-2010
None (Observational study Group intravenous quinine)
Retrospective descriptive study of Group intravenous quinine
Interventions
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None (Observational study Group intravenous artesunate)
Retrospective descriptive study of Group intravenous artesunate
None (Observational study Group intravenous quinine)
Retrospective descriptive study of Group intravenous quinine
Eligibility Criteria
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Inclusion Criteria
* 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
* Opposition to participate in the present study
18 Years
ALL
No
Sponsors
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Dr Fabrice BRUNEEL
OTHER
Responsible Party
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Dr Fabrice BRUNEEL
Investigator MD
Principal Investigators
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Fabrice BRUNEEL, MD
Role: PRINCIPAL_INVESTIGATOR
Versailles Hospital Center
Locations
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Fabrice BRUNEEL
Le Chesnay, Île-de-France Region, France
Countries
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Other Identifiers
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P20/18_Palustar
Identifier Type: -
Identifier Source: org_study_id
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