Skip to main content
OpenTrials
Completed

NCT Number: NCT00372684

PALUREA: Severe Imported Malaria in Adults

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Ch Versailles

Le Chesnay, 78150, France

About this 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 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

with severe malaria hospitalized in ICU

Genetic

with severe malaria hospitalized in ICU

with uncomplicated malaria

Genetic

with uncomplicated malaria

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Collaborators

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

Registry information

Official study title

PALUREA: Severe Falciparum Imported Malaria in Adults: Clinical and Physiopathological Study

Acronym: PALUREA

Important dates

Study start
2006
Primary completion
2010
Study completion
2010
First posted
Sep 7, 2006
Registry last updated
Jun 22, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.