Very Severe Malaria Treated by Intravenous Artesunate (Palustar)

Dr Fabrice BRUNEEL

Status: Completed

Conditions: Severe Malaria

Treatments: Other: None (Observational study Group intravenous artesunate); Other: None (Observational study Group intravenous quinine)

Study type: Observational

Funder types: Other

Identifiers

NCT04516317

P20/18_Palustar

Details and patient eligibility

About

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.

Full description

See Brief Summary

Enrollment: 578 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

578 participants in 2 patient groups

Group intravenous artesunate (around 300 patients)

Description:

Period 2011-2019

Treatment:

Other: None (Observational study Group intravenous artesunate)

Group intravenous quinine (around 300 patients)

Description:

Period 2000-2010

Treatment:

Other: None (Observational study Group intravenous quinine)