PALUREA: Severe Imported Malaria in Adults

NCT ID: NCT00372684

Last Updated: 2010-06-22

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 302 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2006-09-30
• Study Completion Date: 2010-03-31

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.

Conditions

Malaria

Study Design

• Study Time Perspective: PROSPECTIVE

Study Groups

1

with severe malaria hospitalized in ICU

with severe malaria hospitalized in ICU

Intervention Type: GENETIC

with severe malaria hospitalized in ICU

2

with uncomplicated malaria

with uncomplicated malaria

Intervention Type: GENETIC

with uncomplicated malaria

Interventions

with severe malaria hospitalized in ICU

with severe malaria hospitalized in ICU

Intervention Type: GENETIC

with uncomplicated malaria

with uncomplicated malaria

Intervention Type: GENETIC

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Institut National de la Santé Et de la Recherche Médicale, France

OTHER_GOV

Sponsor Role: collaborator

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Department Clinical Research of developpement

Principal Investigators

Fabrice Bruneel, MD

Role: PRINCIPAL_INVESTIGATOR

Assistance Publique - Hôpitaux de Paris

Locations

Ch Versailles

Le Chesnay, , France

Countries

France

References

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.

Reference Type: RESULT

PMID: 12411286 (View on PubMed)

Other Identifiers

AOR05007

Identifier Type: -

Identifier Source: secondary_id

P051063

Identifier Type: -

Identifier Source: org_study_id