Evaluation of Rapid Diagnosis Tests in Imported Malaria

NCT ID: NCT00451269

Last Updated: 2011-02-21

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 1297 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2007-04-30
• Study Completion Date: 2010-01-31

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.

Conditions

Malaria

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Interventions

Rapid diagnosis test for malaria

Rapid diagnosis test for malaria

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• No refusal by patient
• Sample for malaria diagnosis

Exclusion Criteria

• Patient who do not want to participated to the study

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Department of Clinical Research of developpement

Principal Investigators

Sophie MATHERON, MD

Role: PRINCIPAL_INVESTIGATOR

Assistance Publique - Hôpitaux de Paris

Locations

Hopital BICHAT CLAUDE BERNARD

Paris, , France

Countries

France

References

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. doi: 10.1016/j.micinf.2006.07.011. Epub 2006 Aug 10.

Reference Type: RESULT

PMID: 16962361 (View on PubMed)

Other Identifiers

AOR 06066

Identifier Type: -

Identifier Source: org_study_id