Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 11:09 PM
Ignite Modification Date:
2025-12-24 @ 11:09 PM
NCT ID:
NCT00451269
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
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:
NCT00451269
Study Brief:
Protocol Section:
NCT00451269