Clinical Trial: Diagnostic of Puumala Virus Infection in France

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational

Official Title: Puumala Hantavirus Infection in France: Evaluation of Commercial Assays for the Detection of Antibodies Against This Virus and the Use of Urine Samples for the Molecular D

Brief Summary: Routine Puumala virus (PUUV) infection diagnosis is performed using serological commercial kits of which performances have not been established in real life, which use recombinant protein from strains from Central or North Europe. Molecular diagnostic of these infection is not the rule. Consequently the objectives of the project are to evaluate the performances of the serological commercial assays in real life in France and to assess the use of urine versus plasma for the molecular diagnostic of this infection.

Detailed Summary:

Hantaviruses constitute one of the 5 genera in the family Bunyaviridae and are associated with several natural host species including rodents, insectivores and bats. Infection of these species remains unapparent. Transmission of the virus between individuals occurs through direct contact or through inhalation of saliva, feces, or urine. Using these routes, some rodent-borne hantaviruses can be transmitted to humans and cause hemorrhagic fever with renal syndrome or cardiopulmonary syndrome. Human-to-human transmission is rare. There is no specific treatment. Inactivated vaccines against Hantaan and Seoul (SEOV) viruses are only available and licensed in China and South Korea.

Puumala (PUUV), SEOV, Tula and Nova hantaviruses are reported in metropolitan France but only the 2 first are of medical importance. One single human SEOV infection has been confirmed and very few cases have been suspected. In contrast, about 100 PUUV human cases are detected yearly and occurred in the North East quarter of France.

Routine PUUV infection diagnosis is performed using serological commercial kits, allowing detection of IgM or IgG against PUUV or other hantaviruses. The performances (sensitivity and specificity) of these tests as reported by the manufacturers are very good. However, 1/ they have been established with panels of reference sera and not in real life for all assays but one; 2/ these assays are based on N recombinant protein but it has been reported that using whole virus antigens, instead of the single N protein, detection of IgG against hantavirus would be earlier; 3/ PUUV strains used to produce the recombinant N proteins are phylogenetically far from the strains detected in France, and the use of a Belgian strain close to the French strains (instead of a Scandinavian strain) since 1990 has improved the performances of the I
Sponsor: Centre Hospitalier de Charleville-Mézières

Current Primary Outcome: Proportion of patients positive for the detection of IgG or IgM againt PUUV by commercial assays and by molecular/serological techniques [ Time Frame: 33 months ]

Proportion of patients tested positive for the detection of IgG or IgM against PUUV by the use of the commercial assays (index tests) and by the Hantavirus National Reference Center (NRC) molecular and serological techniques (reference tests) according to the information given in the notices of the commercial kits in use and in the version of the standard operating procedure of the Hantavirus NRC in use.


Original Primary Outcome: Same as current

Current Secondary Outcome: Proportion of urine samples tested positive for the detection of PUUV [ Time Frame: 33 months ]

Proportion of urine samples tested positive for IgG or IgM against PUUV compare to plasma sample positive for IgG or IgM against PUUV


Original Secondary Outcome: Same as current

Information By: Centre Hospitalier de Charleville-Mézières

Dates:
Date Received: April 21, 2015
Date Started: July 2015
Date Completion: July 2018
Last Updated: February 1, 2017
Last Verified: February 2017