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Sponsored by: |
Assistance Publique - Hôpitaux de Paris |
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Information provided by: | Assistance Publique - Hôpitaux de Paris |
ClinicalTrials.gov Identifier: | NCT00451269 |
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 | Intervention |
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Malaria |
Device: Rapid diagnosis test for malaria |
Study Type: | Observational |
Study Design: | Case Control, Prospective |
Official Title: | Multicentric Evaluation of Rapid Diagnosis Tests for the Diagnosis of Imported Malaria. |
Estimated Enrollment: | 1225 |
Study Start Date: | April 2007 |
Estimated Study Completion Date: | April 2008 |
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.
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Suspected malaria
Inclusion Criteria:
Exclusion criteria:
Contact: Sophie MATHERON, MD | +33 (0) 1 42 25 78 08 | sophie.matheron@bch.aphp.fr |
France | |
Hopital BICHAT CLAUDE BERNARD | Recruiting |
PARIS, France, 75018 | |
Contact: Sophie MATHERON, MD +33(0) 1 42 25 78 08 sophie.matheron@bch.aphp.fr |
Principal Investigator: | Sophie MATHERON, MD | Assistance Publique - Hôpitaux de Paris |
Study ID Numbers: | AOR 06066 |
Study First Received: | March 21, 2007 |
Last Updated: | November 13, 2007 |
ClinicalTrials.gov Identifier: | NCT00451269 History of Changes |
Health Authority: | France: Ministry of Health |
Malaria Diagnosis RDT pLDH |
HRP2 Patients with fever and history of travel in a malaria country |
Fever Protozoan Infections Parasitic Diseases Malaria |
Protozoan Infections Coccidiosis Parasitic Diseases Malaria |