Ignite Creation Date:
2024-05-05 @ 5:27 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00451269
Status:
COMPLETED
Last Update Posted:
2011-02-21
First Post:
2007-03-21
Brief Title:
Evaluation of Rapid Diagnosis Tests in Imported Malaria
Sponsor:
Assistance Publique - Hôpitaux de Paris
Organization:
Assistance Publique - Hôpitaux de Paris
Study Overview
Official Title:
Multicentric Evaluation of Rapid Diagnosis Tests for the Diagnosis of Imported Malaria
Status:
COMPLETED
Status Verified Date:
2007-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TDR-PALU
Brief Summary:
The annual number of cases of clinical malaria worldwide is estimated to be 300-500 million leading to 15 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 45 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 15 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 45 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None