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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04516317
Other study ID # P20/18_Palustar
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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