- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04516317
Very Severe Malaria Treated by Intravenous Artesunate (Palustar)
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
Status
Conditions
Detailed Description
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Île-de-France
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Le Chesnay, Île-de-France, France, 78150
- Fabrice BRUNEEL
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
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
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
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Group intravenous quinine (around 300 patients)
Period 2000-2010
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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
Sponsor
Investigators
- Principal Investigator: Fabrice BRUNEEL, MD, Versailles Hospital Center
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Infections
- Vector Borne Diseases
- Parasitic Diseases
- Protozoan Infections
- Malaria
- Physiological Effects of Drugs
- Anti-Infective Agents
- Peripheral Nervous System Agents
- Antiviral Agents
- Analgesics
- Sensory System Agents
- Analgesics, Non-Narcotic
- Antineoplastic Agents
- Antiprotozoal Agents
- Antiparasitic Agents
- Neuromuscular Agents
- Antimalarials
- Anthelmintics
- Muscle Relaxants, Central
- Schistosomicides
- Antiplatyhelmintic Agents
- Artesunate
- Quinine
Other Study ID Numbers
- P20/18_Palustar
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
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