NCT02455375

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
179

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2015

Longer than P75 for all trials

Geographic Reach
1 country

10 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 21, 2015

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 27, 2015

Completed
1 month until next milestone

Study Start

First participant enrolled

July 1, 2015

Completed
6.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2021

Completed
Last Updated

August 25, 2023

Status Verified

August 1, 2023

Enrollment Period

6.4 years

First QC Date

April 21, 2015

Last Update Submit

August 24, 2023

Conditions

Nephropathia EpidemicaHemorrhagic Fever With Renal Syndrome

Keywords

Puumala virusdiagnosticFrance

Outcome Measures

Primary Outcomes (1)

  • Proportion of patients positive for the detection of IgG or IgM againt PUUV by commercial assays and by molecular/serological techniques

    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.

    33 months

Secondary Outcomes (1)

  • Proportion of urine samples tested positive for the detection of PUUV

    33 months

Study Arms (2)

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

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients hospitalized for suspected PUUV infection

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

CH Belfort-Montbéliard

Belfort, France

Location

CHU Besançon

Besançon, France

Location

CH Charleville Mézières

Charleville-Mézières, France

Location

CHP Sud de l'Oise

Creil, France

Location

CHU Dijon

Dijon, France

Location

CH de Laon

Laon, France

Location

CHU Reims

Reims, France

Location

CH de Saint Claude

Saint-Claude, France

Location

CHU Nancy

Vandœuvre-lès-Nancy, France

Location

CH de Verdun

Verdun, France

Location

Related Publications (5)

  • Plyusnin A, Horling J, Kanerva M, Mustonen J, Cheng Y, Partanen J, Vapalahti O, Kukkonen SK, Niemimaa J, Henttonen H, Niklasson B, Lundkvist A, Vaheri A. Puumala hantavirus genome in patients with nephropathia epidemica: correlation of PCR positivity with HLA haplotype and link to viral sequences in local rodents. J Clin Microbiol. 1997 May;35(5):1090-6. doi: 10.1128/jcm.35.5.1090-1096.1997.

    PMID: 9114386BACKGROUND

  • Prince HE, Lieberman JM. Impact of the Yosemite hantavirus outbreak on hantavirus antibody testing at a national reference laboratory. Clin Vaccine Immunol. 2013 Aug;20(8):1213-6. doi: 10.1128/CVI.00326-13. Epub 2013 Jun 5.

    PMID: 23740929BACKGROUND

  • Lederer S, Lattwein E, Hanke M, Sonnenberg K, Stoecker W, Lundkvist A, Vaheri A, Vapalahti O, Chan PK, Feldmann H, Dick D, Schmidt-Chanasit J, Padula P, Vial PA, Panculescu-Gatej R, Ceianu C, Heyman P, Avsic-Zupanc T, Niedrig M. Indirect immunofluorescence assay for the simultaneous detection of antibodies against clinically important old and new world hantaviruses. PLoS Negl Trop Dis. 2013 Apr 4;7(4):e2157. doi: 10.1371/journal.pntd.0002157. Print 2013.

    PMID: 23593524BACKGROUND

  • Hentzien M, Mestrallet S, Halin P, Pannet LA, Lebrun D, Drame M, Bani-Sadr F, Galempoix JM, Strady C, Reynes JM, Penalba C, Servettaz A. Bioclinical Test to Predict Nephropathia Epidemica Severity at Hospital Admission. Emerg Infect Dis. 2018 Jun;24(6):1045-1054. doi: 10.3201/eid2406.172160.

    PMID: 29774835BACKGROUND

  • Reynes JM, Schaeffer L, Papadopoulos P, Ait-Ahmed M, Siby-Diakite D, Ripaux-Lefevre M, Buivan TP, Lechat S, Vray M, Galempoix JM; HANTADIAG Study Group. Molecular Detection of Orthohantavirus puumalaense in Plasma and Urine Samples from Hospitalized Patients Presenting with a Serologically Confirmed Acute Hantavirus Infection in France. J Clin Microbiol. 2023 Aug 23;61(8):e0037223. doi: 10.1128/jcm.00372-23. Epub 2023 Jul 24.

    PMID: 37486218RESULT

Biospecimen

Retention: SAMPLES WITHOUT DNA

Urine Plasma Serum

MeSH Terms

Conditions

Hemorrhagic Fever with Renal SyndromeDisease

Condition Hierarchy (Ancestors)

Hantavirus InfectionsBunyaviridae InfectionsRNA Virus InfectionsVirus DiseasesInfectionsHemorrhagic Fevers, ViralPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Jean Marc Galempoix, MD

    CH de Charleville-Mézières

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 21, 2015

First Posted

May 27, 2015

Study Start

July 1, 2015

Primary Completion

November 30, 2021

Study Completion

November 30, 2021

Last Updated

August 25, 2023

Record last verified: 2023-08

Locations

FR(10)