Severe MalariaPalustarNCT04516317
Very Severe Malaria Treated by Intravenous Artesunate
An observational study of Severe Malaria, run by Dr Fabrice BRUNEEL at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Severe Malaria
- What is being tested?
- None (Observational study Group intravenous artesunate) and None (Observational study Group intravenous quinine)
- Type of treatment
- Injection or infusion
- How many people
- 578 participants
- Where
- 1 siteFrance
- Study dates
- 10 Aug 2020to 22 Mar 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Very severe malaria in adults / Antimalarial treatment (Artesunate period 2011-2019 ; Quinine period 2000-2010)
Who may be able to join
- 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
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- 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
Who cannot join
- Less than 18 year-old at the time of inclusion OR
- Opposition to participate in the present study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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.
Read the detailed description
See Brief Summary
- Conditions
- Severe Malaria
- Being tested
- None (Observational study Group intravenous artesunate), None (Observational study Group intravenous quinine)
- Keywords
- Severe Malaria, Artesunate, Critical Care, Quinine
- Medical subject headings
- Malaria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
None (Observational study Group intravenous artesunate)Other
Retrospective descriptive study of Group intravenous artesunate
None (Observational study Group intravenous quinine)Other
Retrospective descriptive study of Group intravenous quinine
| Study group | Role | What they receive |
|---|---|---|
| Group intravenous artesunate (around 300 patients) | Period 2011-2019 Receives: Other: None (Observational study Group intravenous artesunate) | |
| Group intravenous quinine (around 300 patients) | Period 2000-2010 Receives: Other: None (Observational study Group intravenous quinine) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality rate in the Group intravenous artesunate
Mortality reported as a mortality rate (%)
Measured: At hospital discharge, an average of 1 month
Secondary outcomes (1)
Mortality rates in the Group artesunate and Group quinine
Mortality reported as a mortality rate (%)
Measured: At hospital discharge, an average of 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2020
- Study start10 Aug 2020
- Primary completion15 Mar 2022
- Study completion22 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Severe MalariaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 578 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr Fabrice BRUNEEL
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Dr Fabrice BRUNEEL, Versailles Hospital
- Investigators
- Fabrice BRUNEEL, MD, Principal investigator, Versailles Hospital Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04516317
- Sponsor's protocol ID
- P20/18_Palustar
- Acronym
- Palustar
- Status last verified
- Mar 2022
- First submitted
- 9 Jul 2020
- Last updated
- 24 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Very Severe Malaria Treated by Intravenous Artesunate: Epidemiology, Management, Outcome and Prognostic
- ClinicalTrials.gov ID
- NCT04516317
- Acronym / sponsor ID
- Palustar / P20/18_Palustar
- Conditions
- Severe Malaria
- Keywords
- Severe Malaria, Artesunate, Critical Care, Quinine
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 578 participants (actual)
- Lead sponsor
- Dr Fabrice BRUNEELUniversity, hospital or other
- Study start
- 10 Aug 2020 (actual)
- Primary completion
- 15 Mar 2022 (actual)
- Study completion
- 22 Mar 2022 (actual)
- First posted
- 18 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
See Brief Summary
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group intravenous artesunate (around 300 patients) | – | Other: None (Observational study Group intravenous artesunate)Period 2011-2019 |
| Group intravenous quinine (around 300 patients) | – | Other: None (Observational study Group intravenous quinine)Period 2000-2010 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Very severe malaria in adults / Antimalarial treatment (Artesunate period 2011-2019 ; Quinine period 2000-2010)
Key inclusion criteria (10 listed)
- 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 :
Key exclusion criteria (2 listed)
- Less than 18 year-old at the time of inclusion OR
- Opposition to participate in the present study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| None (Observational study Group intravenous artesunate)Retrospective descriptive study of Group intravenous artesunate | Other | Group intravenous artesunate (around 300 patients) |
| None (Observational study Group intravenous quinine)Retrospective descriptive study of Group intravenous quinine | Other | Group intravenous quinine (around 300 patients) |
Primary outcome
Mortality rate in the Group intravenous artesunate
Time frame: At hospital discharge, an average of 1 month
Mortality reported as a mortality rate (%)
1 secondary outcome
Mortality rates in the Group artesunate and Group quinine
Time frame: At hospital discharge, an average of 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fabrice BRUNEEL, MD principal investigator
Versailles Hospital Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Severe Malaria, run by Dr Fabrice BRUNEEL at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality rate in the Group intravenous artesunate (time frame: At hospital discharge, an average of 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2022; AzTrials last refreshed its copy on 7 Nov 2026.