Ignite Creation Date:
2024-05-05 @ 5:04 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00372684
Status:
COMPLETED
Last Update Posted:
2010-06-22
First Post:
2006-09-06
Brief Title:
PALUREA Severe Imported Malaria in Adults
Sponsor:
Assistance Publique - Hôpitaux de Paris
Organization:
Assistance Publique - Hôpitaux de Paris
Study Overview
Official Title:
PALUREA Severe Falciparum Imported Malaria in Adults Clinical and Physiopathological Study
Status:
COMPLETED
Status Verified Date:
2007-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PALUREA
Brief 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 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
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
1 To describe the clinical spectrum of severe imported malaria in France and to assess outcome especially mortality very severe cases and neurological sequelae
2 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
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
1 To describe the clinical spectrum of severe imported malaria in France and to assess outcome especially mortality very severe cases and neurological sequelae
2 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| AOR05007 | None | None | None |