Clinical trial NCT04516317: Very Severe Malaria Treated by Intravenous Artesunate
Official title: Very Severe Malaria Treated by Intravenous Artesunate: Epidemiology, Management, Outcome and Prognostic
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Severe Malaria
Keywords: Severe Malaria
Artesunate
Critical Care
Quinine
Lead sponsor: Versailles Hospital
Sponsor class: OTHER
First posted: 2020-08-18
Enrollment: 578
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Very severe malaria in adults / Antimalarial treatment (Artesunate period 2011-2019 ; Quinine period 2000-2010)

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.

Detailed description: See Brief Summary

Eligibility 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

Primary outcomes:
measure: Mortality rate in the Group intravenous artesunate
timeFrame: At hospital discharge, an average of 1 month
Secondary outcomes:
measure: Mortality rates in the Group artesunate and Group quinine
timeFrame: At hospital discharge, an average of 1 month
Other outcomes:
Locations:
city: Le Chesnay
country: France
facility: Fabrice BRUNEEL
state: Île-de-France
Study officials:
affiliation: Versailles Hospital Center
name: Fabrice BRUNEEL, MD
role: PRINCIPAL_INVESTIGATOR
References: