Hemorrhagic Fever With Renal Syndrome Clinical Trial
— HANTADIAGOfficial 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
NCT number | NCT02455375 |
Other study ID # | PHRC-14-0063 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | July 2015 |
Est. completion date | November 30, 2021 |
Verified date | August 2023 |
Source | Centre Hospitalier de Charleville-Mézières |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 179 |
Est. completion date | November 30, 2021 |
Est. primary completion date | November 30, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
France | CH Belfort-Montbéliard | Belfort | |
France | CHU Besançon | Besançon | |
France | CH Charleville Mézières | Charleville Mézières | |
France | CHP Sud de l'Oise | Creil | |
France | CHU Dijon | Dijon | |
France | CH de Laon | Laon | |
France | CHU Reims | Reims | |
France | CH de Saint Claude | Saint Claude | |
France | CHU Nancy | Vandoeuvre Les Nancy | |
France | CH de Verdun | Verdun |
Lead Sponsor | Collaborator |
---|---|
Centre Hospitalier de Charleville-Mézières | Institut Pasteur |
France,
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. — View Citation
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. Erratum In: PLoS Negl Trop Dis. 2020 Nov 9;14(11):e0008864. — View Citation
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. — View Citation
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. — View Citation
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 Patie — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Proportion of urine samples tested positive for the detection of PUUV | Proportion of urine samples tested positive for IgG or IgM against PUUV compare to plasma sample positive for IgG or IgM against PUUV | 33 months |
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