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NCT Number: NCT04516317

Very Severe Malaria Treated by Intravenous Artesunate

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.

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Key information

Conditions

Severe Malaria Infections Malaria Mosquito-Borne Diseases Parasitic Diseases Protozoan Infections Vector Borne Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Fabrice BRUNEEL

Le Chesnay, Île-de-France Region, 78150, France

About this study

See Brief Summary

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

None (Observational study Group intravenous artesunate)

Other

Retrospective descriptive study of Group intravenous artesunate

None (Observational study Group intravenous quinine)

Other

Retrospective descriptive study of Group intravenous quinine

Primary outcomes

  1. Mortality rate in the Group intravenous artesunate

    Time frame: At hospital discharge, an average of 1 month

    Mortality reported as a mortality rate (%)

Secondary outcomes

  1. Mortality rates in the Group artesunate and Group quinine

    Time frame: At hospital discharge, an average of 1 month

    Mortality reported as a mortality rate (%)

Sponsors and collaborators

Lead sponsor

Dr Fabrice BRUNEEL

Other

Registry information

Official study title

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

Acronym: Palustar

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Aug 18, 2020
Registry last updated
Mar 24, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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