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Diagnostic of Puumala Virus Infection in France (HANTADIAG)

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ClinicalTrials.gov Identifier: NCT02455375
Recruitment Status : Recruiting
First Posted : May 27, 2015
Last Update Posted : February 2, 2017
Sponsor:
Collaborator:
Institut Pasteur
Information provided by (Responsible Party):
Centre Hospitalier de Charleville-Mézières

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.

Condition or disease
Nephropathia Epidemica Hemorrhagic Fever With Renal Syndrome

  Show Detailed Description

Study Type : Observational
Estimated Enrollment : 400 participants
Observational Model: Case-Control
Time Perspective: Prospective
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 Detection of This Infection
Study Start Date : July 2015
Estimated Primary Completion Date : July 2018
Estimated Study Completion Date : July 2018


Group/Cohort
Cases

Case group = group of patients positive with reference tests including serological (ELISA, IF neutralization) and/or molecular assays:

  • detection of PUUV RNA in plasma collected at admission.
  • or/and detection of IgM and IgG against PUUV in serum collected at admission,
  • or/and detection of a seroconversion in IgG against PUUV from admission and late sera
Controls
Control group = group of patients who do not have the criteria listed above



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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


Biospecimen Retention:   Samples Without DNA
Urine Plasma Serum


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients hospitalized for suspected PUUV infection
Criteria

Inclusion Criteria:

Hospitalized patients, male or female, more than 18 years old and less than 76 years old1:

  • having at admission or within 8 days preceding admission a pain , a documented febrile syndrome (body temperature ≥ 38°C) and a platelet count < 150 G/L,
  • exposed to PUUV infection (for the last 6 weeks) or living in a French municipality where Hantavirus infection cases have been recorded during the 2003-2013 period or in a municipality bordering one of them ,
  • giving their written consent after being informed of the research and the collection of data, and blood & urine samples.

NB: persons in emergency situation will be proposed to participate because their situation may affect the performances of laboratory diagnostics.

Exclusion Criteria:

Hospitalized patients:

  • who are known to have been previously diagnosed infected by an hantavirus (medical records and/or laboratory results),
  • who are known to present stable thrombocytopenia,
  • who, according to the medical staff, would not adhere to the protocol,
  • for whom the health status, according to the medical staff, may interfere with the study or is not compatible with the sampling planned in the study.

NB: Pregnant, parturient or breast-feeding women as well as patients under psychiatric care or patients subject to a legal protection order will be not proposed to participate.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02455375


Contacts
Contact: Christian Penalba, MD +33 3 24 58 78 06 cpenalba@ch-charleville-mezieres.fr
Contact: Jean-Marc Reynes, DVM, PhD +33 4 37 28 24 57 jean-marc.reynes@pasteur.fr

Locations
France
CH Belfort-Montbéliard Recruiting
Belfort, France
Principal Investigator: Olivier Ruyet, MD         
CHU Besançon Not yet recruiting
Besançon, France
Principal Investigator: Timothée Klopfenstein, MD         
Principal Investigator: Jean Marc Chalopin, MD         
CH Charleville Mézières Recruiting
Charleville Mézières, France
Principal Investigator: Jean Jacques Dion, MD         
Principal Investigator: Xavier Fontaine, MD         
Principal Investigator: Christian Penalba, MD         
CHP Sud de l'Oise Not yet recruiting
Creil, France
Principal Investigator: Nathalie Landgraf, MD         
Principal Investigator: Renato Demontis, MD         
CHU Dijon Not yet recruiting
Dijon, France
Principal Investigator: Marielle Buisson, MD         
Principal Investigator: Christiane Mousson, MD         
CH de Laon Recruiting
Laon, France
Principal Investigator: Remy Hamon, MD         
Principal Investigator: Magued Nakhla, MD         
Principal Investigator: Xavier Paziot, MD         
CHU Reims Recruiting
Reims, France
Principal Investigator: Firouzé Bani-Sadr, MD         
Principal Investigator: Alain Wynckel, MD         
CH de Saint Claude Not yet recruiting
Saint Claude, France
Principal Investigator: Giovanni Barletta, MD         
Principal Investigator: Omar Dahmani, MD         
CHU Nancy Not yet recruiting
Vandoeuvre Les Nancy, France
Principal Investigator: Thierry May, MD         
Principal Investigator: Luc Frimat, MD         
CH de Verdun Not yet recruiting
Verdun, France
Principal Investigator: Christophe Creusat, MD         
Principal Investigator: Brigitte Gilson, MD         
Sponsors and Collaborators
Centre Hospitalier de Charleville-Mézières
Institut Pasteur
Investigators
Principal Investigator: Christian Penalba, MD CH de Charleville-Mézières

Publications:
Responsible Party: Centre Hospitalier de Charleville-Mézières
ClinicalTrials.gov Identifier: NCT02455375     History of Changes
Other Study ID Numbers: PHRC-14-0063
First Posted: May 27, 2015    Key Record Dates
Last Update Posted: February 2, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Centre Hospitalier de Charleville-Mézières:
Puumala virus
diagnostic
France

Additional relevant MeSH terms:
Hemorrhagic Fevers, Viral
Hemorrhagic Fever with Renal Syndrome
Balkan Nephropathy
RNA Virus Infections
Virus Diseases
Hantavirus Infections
Bunyaviridae Infections
Nephritis, Interstitial
Nephritis
Kidney Diseases
Urologic Diseases