Very Severe Malaria Treated by Intravenous Artesunate

Severe Malaria Clinical Trial

— Palustar  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04516317
• Other study ID #: P20/18_Palustar
• Status: Completed
• Start date: August 10, 2020
• Est. completion date: March 22, 2022

Study information

• Verified date: March 2022
• Source: Versailles Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

See Brief Summary

Recruitment information / eligibility

• Status: Completed
• Enrollment: 578
• Est. completion date: March 22, 2022
• Est. primary completion date: March 15, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Malaria
• Severe Malaria

Intervention

Other:
• None (Observational study Group intravenous artesunate)
Retrospective descriptive study of Group intravenous artesunate
• None (Observational study Group intravenous quinine)
Retrospective descriptive study of Group intravenous quinine

Locations

Country	Name	City	State
France	Fabrice BRUNEEL	Le Chesnay	Île-de-France

Sponsors (1)

Lead Sponsor	Collaborator
Dr Fabrice BRUNEEL

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mortality rate in the Group intravenous artesunate	Mortality reported as a mortality rate (%)	At hospital discharge, an average of 1 month
Secondary	Mortality rates in the Group artesunate and Group quinine	Mortality reported as a mortality rate (%)	At hospital discharge, an average of 1 month