PALUREA: Severe Imported Malaria in Adults

This study has been completed.
Sponsor:
Collaborator:
Institut National de la Santé Et de la Recherche Médicale, France
Information provided by:
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT00372684
First received: September 6, 2006
Last updated: June 18, 2010
Last verified: July 2007
  Purpose

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.


Condition Intervention
Malaria
Genetic: with severe malaria hospitalized in ICU
Genetic: with uncomplicated malaria

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: PALUREA: Severe Falciparum Imported Malaria in Adults: Clinical and Physiopathological Study

Resource links provided by NLM:


Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Biospecimen Retention:   Samples With DNA

physiopathologic


Enrollment: 302
Study Start Date: September 2006
Study Completion Date: March 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
1
with severe malaria hospitalized in ICU
Genetic: with severe malaria hospitalized in ICU
with severe malaria hospitalized in ICU
Other Name: with severe malaria hospitalized in ICU
2
with uncomplicated malaria
Genetic: with uncomplicated malaria
with uncomplicated malaria
Other Name: with uncomplicated malaria

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Patients with severe malaria and patients with uncomplicated malaria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00372684

Locations
France
Ch Versailles
Le Chesnay, France, 78150
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Institut National de la Santé Et de la Recherche Médicale, France
Investigators
Principal Investigator: Fabrice Bruneel, MD Assistance Publique - Hôpitaux de Paris
  More Information

Publications:
Responsible Party: Christophe AUCAN, Department Clinical Research of developpement
ClinicalTrials.gov Identifier: NCT00372684     History of Changes
Other Study ID Numbers: P051063, AOR05007
Study First Received: September 6, 2006
Last Updated: June 18, 2010
Health Authority: France: Ministry of Health

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Plasmodium falciparum
Malaria
Imported malaria
Severe malaria
Uncomplicated malaria
Intensive Care Units
Polymorphism, Genetic
Parasitic Sensitivity Tests
Inflammation Mediators

Additional relevant MeSH terms:
Malaria
Protozoan Infections
Parasitic Diseases

ClinicalTrials.gov processed this record on August 19, 2014