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Evaluation of Rapid Diagnosis Tests in Imported Malaria (TDR-PALU)

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ClinicalTrials.gov Identifier: NCT00451269
Recruitment Status : Completed
First Posted : March 23, 2007
Last Update Posted : February 21, 2011
Sponsor:
Information provided by:

Study Description
Brief Summary:
The annual number of cases of clinical malaria worldwide is estimated to be 300-500 million leading to 1.5 million deaths. Delayed care and frequent drug resistance of Plasmodium falciparum (Pf), the most frequent form of malaria, is responsible for these deaths. Each year, 5000-8000 travellers return to France with malaria, 4/5 from Africa and with Pf. Clinical features associated with a malaria crisis are poorly predictive and misdiagnosis can be easily made. Diagnosis of accurate malaria rely on microscopic examination of stained thin and thick blood films by a well trained microscopist. Few emergency wards are specialized for tropical diseases. For most of them, malaria is a rare disease and hours are lost before accurate microscopy can permit the decision

Condition or disease Intervention/treatment
Malaria Device: Rapid diagnosis test for malaria

Detailed Description:
The annual number of cases of clinical malaria worldwide is estimated to be 300-500 million leading to 1.5 million deaths. Delayed care and frequent drug resistance of Plasmodium falciparum (Pf), the most frequent form of malaria, is responsible for these deaths. Each year, 5000-8000 travellers return to France with malaria, 4/5 from Africa and with Pf. Clinical features associated with a malaria crisis are poorly predictive and misdiagnosis can be easily made. Diagnosis of accurate malaria rely on microscopic examination of stained thin and thick blood films by a well trained microscopist. Few emergency wards are specialized for tropical diseases. For most of them, malaria is a rare disease and hours are lost before accurate microscopy can permit the decision The rapid diagnostic tests (RDT) for malaria are designed to give a sensitive response within 15 minutes. They are based on the immunodetection of HISTIDIN rich protein 2 (HRP2) or the Pf LACTICO dehydrogenase (PfLDH), specific of Plasmodium falciparum or plasmodial LACTICO dehydrogenase (pLDH), or aldolase, specific of gender of the four species of human malaria. Recent increase of performances and availability prompted WHO to recommend their use for the diagnosis of malaria when microscopy is unavailable. In France, competence exists on the whole of the territory but expertise is usually confined to major referral centers. We intend to evaluate the performances of 4 RDT in 6 laboratories who perform the diagnosis of malaria on patients samples who returned from tourist or family or professional trips. The simultaneous detection of the plasmodial HRP2, PfLDH, aldolase and pLDH will be compared with the thick blood film as reference. Discrepant results will be analysed by PCR. The determination of the sensitivity, the specificity, the predictive positive value and the predictive negative value of the RDT is the principal objective.

Study Design

Study Type : Observational
Actual Enrollment : 1297 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: Multicentric Evaluation of Rapid Diagnosis Tests for the Diagnosis of Imported Malaria.
Study Start Date : April 2007
Primary Completion Date : January 2010
Study Completion Date : January 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Malaria
U.S. FDA Resources

Groups and Cohorts

Intervention Details:
    Device: Rapid diagnosis test for malaria
    Rapid diagnosis test for malaria

Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Suspected malaria
Criteria

Inclusion Criteria:

  • No refusal by patient
  • Sample for malaria diagnosis

Exclusion criteria:

  • Patient who do not want to participated to the study
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00451269


Locations
France
Hopital BICHAT CLAUDE BERNARD
Paris, France, 75018
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Principal Investigator: Sophie MATHERON, MD Assistance Publique - Hôpitaux de Paris
More Information

Publications:
Responsible Party: Christophe AUCAN, Department of Clinical Research of developpement
ClinicalTrials.gov Identifier: NCT00451269     History of Changes
Other Study ID Numbers: AOR 06066
First Posted: March 23, 2007    Key Record Dates
Last Update Posted: February 21, 2011
Last Verified: March 2007

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Malaria
Diagnosis
RDT
pLDH
HRP2
Patients with fever and history of travel in a malaria
country

Additional relevant MeSH terms:
Malaria
Protozoan Infections
Parasitic Diseases