Palustar: Very Severe Malaria Treated by Intravenous Artesunate

Sponsor
Dr Fabrice BRUNEEL (Other)
Overall Status
Completed
CT.gov ID
NCT04516317
Collaborator
(none)
578
1
19.4
29.9

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: None (Observational study Group intravenous artesunate)
  • Other: None (Observational study Group intravenous quinine)

Detailed Description

See Brief Summary

Study Design

Study Type:
Observational
Actual Enrollment :
578 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
Very Severe Malaria Treated by Intravenous Artesunate: Epidemiology, Management, Outcome and Prognostic
Actual Study Start Date :
Aug 10, 2020
Actual Primary Completion Date :
Mar 15, 2022
Actual Study Completion Date :
Mar 22, 2022

Arms and Interventions

Arm Intervention/Treatment
Group intravenous artesunate (around 300 patients)

Period 2011-2019

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

Group intravenous quinine (around 300 patients)

Period 2000-2010

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

Outcome Measures

Primary Outcome Measures

  1. Mortality rate in the Group intravenous artesunate [At hospital discharge, an average of 1 month]

    Mortality reported as a mortality rate (%)

Secondary Outcome Measures

  1. Mortality rates in the Group artesunate and Group quinine [At hospital discharge, an average of 1 month]

    Mortality reported as a mortality rate (%)

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Fabrice BRUNEEL Le Chesnay Île-de-France France 78150

Sponsors and Collaborators

  • Dr Fabrice BRUNEEL

Investigators

  • Principal Investigator: Fabrice BRUNEEL, MD, Versailles Hospital Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Dr Fabrice BRUNEEL, Investigator MD, Versailles Hospital
ClinicalTrials.gov Identifier:
NCT04516317
Other Study ID Numbers:
  • P20/18_Palustar
First Posted:
Aug 18, 2020
Last Update Posted:
Mar 24, 2022
Last Verified:
Mar 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Dr Fabrice BRUNEEL, Investigator MD, Versailles Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 24, 2022