Clinical trial NCT04172025: Development of a Swiss Surveillance Database for Molecular Epidemiology of Hypervirulent and Multi-drug Resistant Pathogens
Official title: Development of a Swiss Surveillance Database for Molecular Epidemiology of Hypervirulent and Multi-drug Resistant Pathogens
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Multiresistant Bacterial Pathogens
Virulent Bacterial Pathogens
Keywords: Epidemiology
surveillance
bacterial pathogens
Database
Genotyping
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
Collaborators: name: Swiss National Science Foundation
First posted: 2019-11-21
Enrollment: 10000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: • All patients with either colonisations or infections with either a bacterial or a viral pathogens including the below listed pathogens from participating centers in Switzerland.

Brief summary: 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: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Identification of transmission clusters based on genetic similarity.
timeFrame: Onetime identification at baseline
Secondary outcomes:
measure: Detection of Genotypic Resistance
timeFrame: Onetime identification at baseline
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: University Hospital Basel
city: Bern
country: Switzerland
facility: University of Bern
city: Geneva
country: Switzerland
facility: University Hospital Geneva
city: Lausanne
country: Switzerland
facility: University Hospital Lausanne CHUV
city: Zurich
country: Switzerland
facility: University of Zurich
Study officials:
affiliation: Biozentrum, University of Basel
name: Hans Hirsch, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
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