Very Severe Malaria Treated by Intravenous Artesunate

Study Overview
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Brief Summary
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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
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See Brief Summary

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

Conditions
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Severe Malaria

Intervention / Treatment
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* Other: None (Observational study Group intravenous artesunate)
* Other: None (Observational study Group intravenous quinine)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group intravenous artesunate (around 300 patients)<br>Period 2011-2019 | Other: None (Observational study Group intravenous artesunate)<br>* Retrospective descriptive study of Group intravenous artesunate<br>|
| Group intravenous quinine (around 300 patients)<br>Period 2000-2010 | Other: None (Observational study Group intravenous quinine)<br>* Retrospective descriptive study of Group intravenous quinine<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality rate in the Group intravenous artesunate | Mortality reported as a mortality rate (%) | At hospital discharge, an average of 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality rates in the Group artesunate and Group quinine | Mortality reported as a mortality rate (%) | At hospital discharge, an average of 1 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Severe Malaria, Artesunate, Critical Care, Quinine