Clinical trial NCT00372684: PALUREA: Severe Imported Malaria in Adults
Official title: PALUREA: Severe Falciparum Imported Malaria in Adults: Clinical and Physiopathological Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Malaria
Keywords: Plasmodium falciparum
Malaria
Imported malaria
Severe malaria
Uncomplicated malaria
Intensive Care Units
Polymorphism, Genetic
Parasitic Sensitivity Tests
Inflammation Mediators
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
Collaborators: name: Institut National de la Santé Et de la Recherche Médicale, France
First posted: 2006-09-07
Enrollment: 302
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with severe malaria and patients with uncomplicated malaria

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.

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.

Eligibility criteria: Inclusion Criteria:

Inclusion Criteria in Severe Malaria Group:

* 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

Inclusion Criteria in Uncomplicated Malaria Group:

* 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

Exclusion Criteria:

* Patient \< 18 years-old
* Impossible to obtain informed consent
* Curative treatment of malaria for more than 72 hours

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Le Chesnay
country: France
facility: Ch Versailles
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Fabrice Bruneel, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.