Development of a Swiss Surveillance Database for Molecular Epidemiology of Hypervirulent and Multi-drug Resistant Pathogens

NCT ID: NCT04172025

Last Updated: 2025-05-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

10000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-09-30

Study Completion Date

2029-12-31

Brief Summary

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Hypervirulent and multidrug-resistant infections are associated with significant health care costs, substantial morbidity and mortality. Therefore, the rapid recognition of outbreaks and transmissions with hypervirulent and multi-drug resistant pathogen is a key priority for infection control and public health.The main goal is to implement a shared database, connecting human and veterinary microbiology laboratories, which would allow near real-time molecular epidemiology with high spatiotemporal resolution of bacterial pathogens such as transmission and outbreak surveillance between different compartments including humans, animals and the environment in Switzerland. Investigator aims to analyze already collected encoded retrospective datasets of various pathogens by combining epidemiological data and whole genome sequences from pathogens.

Detailed Description

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Hypervirulent and multidrug-resistant infections are associated with significant health care costs, substantial morbidity and mortality. Therefore, the rapid recognition of outbreaks and transmissions with hypervirulent and multi-drug resistant pathogen is a key priority for infection control and public health. For hospital epidemiologist, infectious disease and public health experts, and microbiologists the identification of an outbreak source is a first important step to establish effective counter-measurements. In Switzerland, the burden of pathogen transmission between humans, animals and the environment is substantial. The main goal is to implement a shared database, connecting human and veterinary microbiology laboratories, which would allow near real-time molecular epidemiology with high spatiotemporal resolution of bacterial pathogens such as transmission and outbreak surveillance between different compartments including humans, animals and the environment in Switzerland. Investigator aims to analyze already collected encoded retrospective datasets of various pathogens by combining epidemiological data and whole genome sequences from pathogens.

Conditions

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Multiresistant Bacterial Pathogens Virulent Bacterial Pathogens

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Patients with colonization or infections with a pathogen

All patients with either colonisations or infections with either a bacterial or a viral pathogen, where whole genome sequencing data and available minimal epidemiological, demographic and clinical data

Analysis of Bacterial Genome

Intervention Type DIAGNOSTIC_TEST

genome assembly; prediction of sequence type (MLST); core genome MLST tree to rapidly compare strains within a project; core genome single nucleotide polymorphism (SNP) tree to compare all Swiss Pathogen Surveillance Platform (SPSP) strains belonging to a same species; whole genome SNP tree to compare all SPSP strains within the same species and ST;; prediction of resistance and virulence factors within pathogen submitted genomes; time trees and calculation of transmission rates, including basic reproduction number; analysis of classical epidemiological data with advanced statistical methods including machine learning.

Interventions

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Analysis of Bacterial Genome

genome assembly; prediction of sequence type (MLST); core genome MLST tree to rapidly compare strains within a project; core genome single nucleotide polymorphism (SNP) tree to compare all Swiss Pathogen Surveillance Platform (SPSP) strains belonging to a same species; whole genome SNP tree to compare all SPSP strains within the same species and ST;; prediction of resistance and virulence factors within pathogen submitted genomes; time trees and calculation of transmission rates, including basic reproduction number; analysis of classical epidemiological data with advanced statistical methods including machine learning.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* All patients with either colonisations or infections with either a bacterial or a viral pathogen, where whole genome sequencing data and available minimal epidemiological, demographic and clinical data
* Pathogens included into analysis are: Multidrug-resistant bacteria include: methicillin resistant Staphylococcus aureus (MRSA), Carbapenemase- and/or extended spectrum betalactamase (ESBL)-producing Enterobacteriaceae and non-fermenting bacteria including Pseudomonas aeruginosa and Acinetobacter baumannii, Vancomycin resistant Enterococcus faecium, and others; virulent bacteria include: Neisseria meningitidis, Neisseria gonorrhoeae, Mycobacterium tuberculosis, Campylobacter spp., Salmonella spp., Legionella pneumophila, Listeria monocytogenes, and Streptococcus pneumoniae, and others; Viruses include: Influenza viruses, Measles virus, Enterovirus E68, Respiratory Syncytial Virus and others.

Exclusion Criteria

* Decline to sign a general consent or any other declining statement against using data for research purposes.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Swiss National Science Foundation

OTHER

Sponsor Role collaborator

University Hospital, Basel, Switzerland

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Hans Hirsch, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

Biozentrum, University of Basel

Locations

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University Hospital Basel

Basel, , Switzerland

Site Status RECRUITING

University of Bern

Bern, , Switzerland

Site Status RECRUITING

University Hospital Geneva

Geneva, , Switzerland

Site Status RECRUITING

University Hospital Lausanne CHUV

Lausanne, , Switzerland

Site Status RECRUITING

University of Zurich

Zurich, , Switzerland

Site Status RECRUITING

Countries

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Switzerland

Central Contacts

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Hans Hirsch, Prof. Dr.

Role: CONTACT

+41 61 32 86697

Aitana Lebrand, Dr.

Role: CONTACT

Facility Contacts

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Hans Hirsch, Prof. Dr.

Role: primary

+41 61 32 86697

Vincent Perreten, Prof.

Role: primary

Stephen Leib, Prof.

Role: backup

Jacques Schrenzel, Prof.

Role: primary

Laurent Kaiser, Prof.

Role: backup

Gilbert Greub, Prof.

Role: primary

Dominique Blanc, PD Dr.

Role: backup

Michael Huber, Dr.

Role: primary

Roger Stephan, Prof.

Role: backup

References

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Reference Type BACKGROUND
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Reference Type BACKGROUND
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Reference Type BACKGROUND
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Seth-Smith HMB, Casanova C, Sommerstein R, Meinel DM, Abdelbary MMH, Blanc DS, Droz S, Fuhrer U, Lienhard R, Lang C, Dubuis O, Schlegel M, Widmer A, Keller PM, Marschall J, Egli A. Phenotypic and Genomic Analyses of Burkholderia stabilis Clinical Contamination, Switzerland. Emerg Infect Dis. 2019 Jun;25(6):1084-1092. doi: 10.3201/eid2506.172119.

Reference Type BACKGROUND
PMID: 31107229 (View on PubMed)

Sommerstein R, Fuhrer U, Lo Priore E, Casanova C, Meinel DM, Seth-Smith HM, Kronenberg A; Anresis; Koch D, Senn L, Widmer AF, Egli A, Marschall J; Swissnoso. Burkholderia stabilis outbreak associated with contaminated commercially-available washing gloves, Switzerland, May 2015 to August 2016. Euro Surveill. 2017 Dec;22(49):17-00213. doi: 10.2807/1560-7917.ES.2017.22.49.17-00213.

Reference Type BACKGROUND
PMID: 29233255 (View on PubMed)

Stucki D, Ballif M, Egger M, Furrer H, Altpeter E, Battegay M, Droz S, Bruderer T, Coscolla M, Borrell S, Zurcher K, Janssens JP, Calmy A, Mazza Stalder J, Jaton K, Rieder HL, Pfyffer GE, Siegrist HH, Hoffmann M, Fehr J, Dolina M, Frei R, Schrenzel J, Bottger EC, Gagneux S, Fenner L. Standard Genotyping Overestimates Transmission of Mycobacterium tuberculosis among Immigrants in a Low-Incidence Country. J Clin Microbiol. 2016 Jul;54(7):1862-1870. doi: 10.1128/JCM.00126-16. Epub 2016 May 18.

Reference Type BACKGROUND
PMID: 27194683 (View on PubMed)

Walker TM, Merker M, Knoblauch AM, Helbling P, Schoch OD, van der Werf MJ, Kranzer K, Fiebig L, Kroger S, Haas W, Hoffmann H, Indra A, Egli A, Cirillo DM, Robert J, Rogers TR, Groenheit R, Mengshoel AT, Mathys V, Haanpera M, Soolingen DV, Niemann S, Bottger EC, Keller PM; MDR-TB Cluster Consortium. A cluster of multidrug-resistant Mycobacterium tuberculosis among patients arriving in Europe from the Horn of Africa: a molecular epidemiological study. Lancet Infect Dis. 2018 Apr;18(4):431-440. doi: 10.1016/S1473-3099(18)30004-5. Epub 2018 Jan 8.

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Ward DV, Hoss AG, Kolde R, van Aggelen HC, Loving J, Smith SA, Mack DA, Kathirvel R, Halperin JA, Buell DJ, Wong BE, Ashworth JL, Fortunato-Habib MM, Xu L, Barton BA, Lazar P, Carmona JJ, Mathew J, Salgo IS, Gross BD, Ellison RT. Integration of genomic and clinical data augments surveillance of healthcare-acquired infections. Infect Control Hosp Epidemiol. 2019 Jun;40(6):649-655. doi: 10.1017/ice.2019.75. Epub 2019 Apr 23.

Reference Type BACKGROUND
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Wassilew N, Seth-Smith HM, Rolli E, Fietze Y, Casanova C, Fuhrer U, Egli A, Marschall J, Buetti N. Outbreak of vancomycin-resistant Enterococcus faecium clone ST796, Switzerland, December 2017 to April 2018. Euro Surveill. 2018 Jul;23(29):1800351. doi: 10.2807/1560-7917.ES.2018.23.29.1800351.

Reference Type BACKGROUND
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Wuthrich D, Gautsch S, Spieler-Denz R, Dubuis O, Gaia V, Moran-Gilad J, Hinic V, Seth-Smith HM, Nickel CH, Tschudin-Sutter S, Bassetti S, Haenggi M, Brodmann P, Fuchs S, Egli A. Air-conditioner cooling towers as complex reservoirs and continuous source of Legionella pneumophila infection evidenced by a genomic analysis study in 2017, Switzerland. Euro Surveill. 2019 Jan;24(4):1800192. doi: 10.2807/1560-7917.ES.2019.24.4.1800192.

Reference Type BACKGROUND
PMID: 30696527 (View on PubMed)

Other Identifiers

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2019-01291; qu19Egli5

Identifier Type: -

Identifier Source: org_study_id

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