Very Severe Malaria Treated by Intravenous Artesunate (Palustar)

March 23, 2022 updated by: Dr Fabrice BRUNEEL

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

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.

Study Overview

Detailed Description

See Brief Summary

Study Type

Observational

Enrollment (Actual)

578

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Île-de-France
      • Le Chesnay, Île-de-France, France, 78150
        • Fabrice BRUNEEL

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Very severe malaria in adults / Antimalarial treatment (Artesunate period 2011-2019 ; Quinine period 2000-2010)

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Group intravenous artesunate (around 300 patients)
Period 2011-2019
Retrospective descriptive study of Group intravenous artesunate
Group intravenous quinine (around 300 patients)
Period 2000-2010
Retrospective descriptive study of Group intravenous quinine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mortality rate in the Group intravenous artesunate
Time Frame: At hospital discharge, an average of 1 month
Mortality reported as a mortality rate (%)
At hospital discharge, an average of 1 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mortality rates in the Group artesunate and Group quinine
Time Frame: At hospital discharge, an average of 1 month
Mortality reported as a mortality rate (%)
At hospital discharge, an average of 1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 10, 2020

Primary Completion (Actual)

March 15, 2022

Study Completion (Actual)

March 22, 2022

Study Registration Dates

First Submitted

July 9, 2020

First Submitted That Met QC Criteria

August 13, 2020

First Posted (Actual)

August 18, 2020

Study Record Updates

Last Update Posted (Actual)

March 24, 2022

Last Update Submitted That Met QC Criteria

March 23, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Severe Malaria

Clinical Trials on None (Observational study Group intravenous artesunate)

Subscribe