Very Severe Malaria Treated by Intravenous Artesunate

Completed

• Conditions: Severe Malaria
• Interventions: Other: None (Observational study Group intravenous artesunate); Other: None (Observational study Group intravenous quinine)

• Registration Number: NCT04516317
• Lead Sponsor: Dr Fabrice BRUNEEL

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

Study Timeline

• Study First Submitted: 2020-07-09
• Study Start: 2020-08-10
• Study First Submitted QC: 2020-08-13
• Study First Posted: 2020-08-18
• Status Verified: 2022-03
• Primary Completion: 2022-03-15
• Study Completion: 2022-03-22
• Last Update Submitted: 2022-03-23
• Last Update Posted: 2022-03-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 578

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group intravenous artesunate (around 300 patients)	None (Observational study Group intravenous artesunate)	Period 2011-2019
Group intravenous quinine (around 300 patients)	None (Observational study Group intravenous quinine)	Period 2000-2010

Primary Outcome Measures

Name	Time	Method
Mortality rate in the Group intravenous artesunate	At hospital discharge, an average of 1 month	Mortality reported as a mortality rate (%)

Secondary Outcome Measures

Name	Time	Method
Mortality rates in the Group artesunate and Group quinine	At hospital discharge, an average of 1 month	Mortality reported as a mortality rate (%)

Trial Locations

Locations (1)

Fabrice BRUNEEL; 🇫🇷 Le Chesnay, Île-de-France, France