MalariaPALUREANCT00372684
PALUREA: Severe Imported Malaria in Adults
An observational study of Malaria, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
Plasmodium falciparum malaria remains a major public health problem in endemic areas, with approximately 2 million deaths each year, especially in tropical African countries. In non-endemic industrialized areas, imported malaria is generally diagnosed in travelers, as well as immigrants from endemic countries. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malaria
- What is being tested?
- with severe malaria hospitalized in ICU and with uncomplicated malaria
- How many people
- 302 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2006to Mar 2010
- 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: Patients with severe malaria and patients with uncomplicated malaria
Who may be able to join
- Hospitalization in the ICU and
- Presence of asexual forms of Plasmodium falciparum in the blood and
- One or more severe manifestations according to the World Health Organization (WHO) definition of severe falciparum malaria published in 2000
- Hospitalization in Medicine unit or ambulatory and
- Presence of asexual forms of Plasmodium falciparum in the blood and
- Absence of any severe manifestation according to the WHO definition of severe falciparum malaria published in 2000 with the exception of the criteria hyper parasitaemia (superior4%) when isolated or the criteria jaundice /total bilirubin superior 5 micromol/L when isolated
Who cannot join
- Patient < 18 years-old
- Impossible to obtain informed consent
- Curative treatment of malaria for more than 72 hours
Trial locations and contacts
1 site in 1 country.
About this study
Official title: PALUREA: Severe Falciparum Imported Malaria in Adults: Clinical and Physiopathological Study
Plasmodium falciparum malaria remains a major public health problem in endemic areas, with approximately 2 million deaths each year, especially in tropical African countries.
In non-endemic industrialized areas, imported malaria is generally diagnosed in travelers, as well as immigrants from endemic countries. Such imported cases have increased worldwide, with approximately 7000 cases each year in France. Among these cases, 300 are severe requiring hospitalization in the intensive care unit (ICU) with an overall mortality rate of 10%, despite available effective care.
Read more
Many studies have been performed to evaluate clinical and physiopathological aspects of severe malaria in endemic areas but few data are available for imported malaria. Therefore, determinants of severe imported malaria are not well known. The majority of patients hospitalized in the ICU for severe malaria are white caucasians as well as those patients who die.
The present study has two main objectives:
(i) to describe the clinical spectrum of severe imported malaria and to assess outcome (mortality and neurological sequelae), and the biological interactions between host and the parasite,
(ii) to evaluate the role of gene polymorphisms, of parasitic factors in the occurrence of severe malaria with a case control study comparing severe and non-severe malaria in patients matched according to ethnic patterns. The intensity of the inflammatory response will also be studied in the two groups of patients.
Read the detailed description
Plasmodium falciparum malaria remains a major public health problem in endemic areas, with approximately 2 million deaths each year, especially in tropical African countries.
In non-endemic industrialized areas, imported malaria is generally diagnosed in travelers, as well as immigrants from endemic countries. Such imported cases have increased worldwide, with approximately 7000 cases each year in France. Among these cases, 300 are severe requiring hospitalization in ICU with an overall mortality rate of 10%, despite available effective care.
Many studies have been performed to evaluate clinical and physiopathological aspects of severe malaria in endemic areas but few data are available for imported malaria. Therefore, determinants of severe imported malaria are not well known. The majority of patients hospitalized in ICU for severe imported malaria are white caucasians, as well as those patients who die.
The present two-year prospective multicentric nationwide study has two main objectives:
- To describe the clinical spectrum of severe imported malaria in France and to assess outcome (especially mortality, very severe cases, and neurological sequelae).
- To analyse the biological interactions between host and the parasite, by evaluating: the role of gene polymorphisms of the host including haemoglobin analysis, the intensity of inflammatory response, endothelial activation, and finally several plasmodial factors.
We hope to include 150 to 200 patients with severe malaria hospitalized in ICU and 150 to 200 patients with uncomplicated malaria. These two groups will be included in a case control study comparing severe and non-severe malaria with matching according to ethnic patterns.
- Conditions
- Malaria
- Being tested
- with severe malaria hospitalized in ICU, with uncomplicated malaria
- Keywords
- Plasmodium falciparum, Malaria, Imported malaria, Severe malaria, Uncomplicated malaria, Intensive Care Units, Polymorphism, Genetic, Parasitic Sensitivity Tests, Inflammation Mediators
- Medical subject headings
- Malaria, Malaria, Falciparum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
with severe malaria hospitalized in ICUGenetic
with severe malaria hospitalized in ICU
with uncomplicated malariaGenetic
with uncomplicated malaria
| Study group | Role | What they receive |
|---|---|---|
| 1 | with severe malaria hospitalized in ICU Receives: Genetic: with severe malaria hospitalized in ICU | |
| 2 | with uncomplicated malaria Receives: Genetic: with uncomplicated malaria |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2006 (estimated)
- Study startSep 2006
- Primary completionMar 2010
- Study completionMar 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for MalariaStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- 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
- Time perspective
- Prospective
- Enrolment
- 302 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Investigators
- Fabrice Bruneel, MD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00372684
- Sponsor's protocol ID
- P051063
- Other IDs
- AOR05007
- Acronym
- PALUREA
- Status last verified
- Jul 2007
- First submitted
- 6 Sep 2006
- Last updated
- 22 Jun 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Bruneel F, Hocqueloux L, Alberti C, Wolff M, Chevret S, Bedos JP, Durand R, Le Bras J, Regnier B, Vachon F. The clinical spectrum of severe imported falciparum malaria in the intensive care unit: report of 188 cases in adults. Am J Respir Crit Care Med. 2003 Mar 1;167(5):684-9. doi: 10.1164/rccm.200206-631OC. Epub 2002 Oct 31.
PubMed 12411286
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PALUREA: Severe Falciparum Imported Malaria in Adults: Clinical and Physiopathological Study
- ClinicalTrials.gov ID
- NCT00372684
- Acronym / sponsor ID
- PALUREA / P051063
- Conditions
- Malaria
- Keywords
- Plasmodium falciparum, Malaria, Imported malaria, Severe malaria, Uncomplicated malaria, Intensive Care Units, Polymorphism, Genetic, Parasitic Sensitivity Tests
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 302 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- Institut National de la Santé Et de la Recherche Médicale, France
- Study start
- Sep 2006
- Primary completion
- Mar 2010 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 7 Sep 2006 (estimated)
- 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.
Plasmodium falciparum malaria remains a major public health problem in endemic areas, with approximately 2 million deaths each year, especially in tropical African countries.
In non-endemic industrialized areas, imported malaria is generally diagnosed in travelers, as well as immigrants from endemic countries. Such imported cases have increased worldwide, with approximately 7000 cases each year in France. Among these cases, 300 are severe requiring hospitalization in the intensive care unit (ICU) with an overall mortality rate of 10%, despite available effective care.
Many studies have been performed to evaluate clinical and physiopathological aspects of severe malaria in endemic areas but few data are available for imported malaria. Therefore, determinants of severe imported malaria are not well known. The majority of patients hospitalized in the ICU for severe malaria are white caucasians as well as those patients who die.
The present study has two main objectives:
(i) to describe the clinical spectrum of severe imported malaria and to assess outcome (mortality and neurological sequelae), and the biological interactions between host and the parasite,
(ii) to evaluate the role of gene polymorphisms, of parasitic factors in the occurrence of severe malaria with a case control study comparing severe and non-severe malaria in patients matched according to ethnic patterns. The intensity of the inflammatory response will also be studied in the two groups of patients.
Detailed description
Plasmodium falciparum malaria remains a major public health problem in endemic areas, with approximately 2 million deaths each year, especially in tropical African countries.
In non-endemic industrialized areas, imported malaria is generally diagnosed in travelers, as well as immigrants from endemic countries. Such imported cases have increased worldwide, with approximately 7000 cases each year in France. Among these cases, 300 are severe requiring hospitalization in ICU with an overall mortality rate of 10%, despite available effective care.
Many studies have been performed to evaluate clinical and physiopathological aspects of severe malaria in endemic areas but few data are available for imported malaria. Therefore, determinants of severe imported malaria are not well known. The majority of patients hospitalized in ICU for severe imported malaria are white caucasians, as well as those patients who die.
The present two-year prospective multicentric nationwide study has two main objectives:
- To describe the clinical spectrum of severe imported malaria in France and to assess outcome (especially mortality, very severe cases, and neurological sequelae).
- To analyse the biological interactions between host and the parasite, by evaluating: the role of gene polymorphisms of the host including haemoglobin analysis, the intensity of inflammatory response, endothelial activation, and finally several plasmodial factors.
We hope to include 150 to 200 patients with severe malaria hospitalized in ICU and 150 to 200 patients with uncomplicated malaria. These two groups will be included in a case control study comparing severe and non-severe malaria with matching according to ethnic patterns.
Study design
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Genetic: with severe malaria hospitalized in ICUwith severe malaria hospitalized in ICU |
| 2 | – | Genetic: with uncomplicated malariawith uncomplicated malaria |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with severe malaria and patients with uncomplicated malaria
Key inclusion criteria (6 listed)
- Hospitalization in the ICU and
- Presence of asexual forms of Plasmodium falciparum in the blood and
- One or more severe manifestations according to the World Health Organization (WHO) definition of severe falciparum malaria published in 2000
- Hospitalization in Medicine unit or ambulatory and
- Presence of asexual forms of Plasmodium falciparum in the blood and
Key exclusion criteria (3 listed)
- Patient < 18 years-old
- Impossible to obtain informed consent
- Curative treatment of malaria for more than 72 hours
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 |
|---|---|---|
| with severe malaria hospitalized in ICUwith severe malaria hospitalized in ICU | Genetic | 1 |
| with uncomplicated malariawith uncomplicated malaria | Genetic | 2 |
Primary outcome
Not reported in the source record.
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 22 Jun 2010.
- Results publication: PubMed 12411286Bruneel F, Hocqueloux L, Alberti C, Wolff M, Chevret S, Bedos JP, Durand R, Le Bras J, Regnier B, Vachon F. The clinical spectrum of severe imported falciparum malaria in the intensive care unit: report of 188 cases in adults. Am J Respir Crit Care Med. 2003 Mar 1;167(5):684-9. doi: 10.1164/rccm.200206-631OC. Epub 2002 Oct 31.
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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
Assistance Publique - Hôpitaux de Paris
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 Malaria, run by Assistance Publique - Hôpitaux de Paris 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 6 inclusion and 3 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 22 Jun 2010. 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00372684, which also lists 1 linked publication.
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 22 Jun 2010; AzTrials last refreshed its copy on 6 Nov 2026.