Evaluation of Rapid Diagnosis Tests in Imported Malaria

Malaria Clinical Trial

— TDR-PALU  

Official title:

Multicentric Evaluation of Rapid Diagnosis Tests for the Diagnosis of Imported Malaria.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00451269
• Other study ID #: AOR 06066
• Status: Completed
• Phase: N/A
• First received: March 21, 2007
• Last updated: February 18, 2011
• Start date: April 2007
• Est. completion date: January 2010

Study information

• Verified date: March 2007
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1297
• Est. completion date: January 2010
• Est. primary completion date: January 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• No refusal by patient

• Sample for malaria diagnosis

Exclusion criteria:

• Patient who do not want to participated to the study

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Malaria

Intervention

Device:
• Rapid diagnosis test for malaria
Rapid diagnosis test for malaria

Locations

Country	Name	City	State
France	Hopital BICHAT CLAUDE BERNARD	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

References & Publications (1)

Musset L, Bouchaud O, Matheron S, Massias L, Le Bras J. Clinical atovaquone-proguanil resistance of Plasmodium falciparum associated with cytochrome b codon 268 mutations. Microbes Infect. 2006 Sep;8(11):2599-604. Epub 2006 Aug 10. — View Citation