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

December 15, 2021 updated by: University Hospital, Basel, Switzerland
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Anticipated)

10000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Switzerland
      • Basel, Switzerland, 4031
        • Recruiting
        • University Hospital Basel
        • Contact:
        • Contact:
        • Principal Investigator:
          • Adrian Egli, MD PhD
        • Principal Investigator:
          • Hans Hirsch, Prof.
      • Bern, Switzerland, 3012
        • Recruiting
        • University of Bern
        • Contact:
          • Vincent Perreten, Prof.
        • Contact:
          • Stephen Leib, Prof.
        • Principal Investigator:
          • Vincent Perreten, Prof.
        • Principal Investigator:
          • Stephen Leib, Prof.
      • Geneva, Switzerland, 1205
        • Recruiting
        • University Hospital Geneva
        • Contact:
          • Jacques Schrenzel, Prof.
        • Contact:
          • Laurent Kaiser, Prof.
        • Principal Investigator:
          • Laurent Kaiser, Prof.
        • Principal Investigator:
          • Jacques Schrenzel, Prof.
        • Principal Investigator:
          • Aitana Lebrand, Dr.
      • Lausanne, Switzerland, 1011
        • Recruiting
        • University Hospital Lausanne CHUV
        • Contact:
          • Gilbert Greub, Prof.
        • Contact:
          • Dominique Blanc, PD Dr.
        • Principal Investigator:
          • Gilbert Greub, Prof.
        • Principal Investigator:
          • Dominique Blanc, PD Dr.
      • Zurich, Switzerland, 8057
        • Recruiting
        • University of Zurich
        • Contact:
          • Michael Huber, Dr.
        • Contact:
          • Roger Stephan, Prof.
        • Principal Investigator:
          • Michael Huber, Dr.
        • Principal Investigator:
          • Reinhard Zbinden, Prof.
        • Principal Investigator:
          • Roger Stephan, Prof.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
Diagnostic test: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Identification of transmission clusters based on genetic similarity.
Time Frame: Onetime identification at baseline
Identification of transmission clusters based on genetic similarity. With focus on whole genome sequencing.
Onetime identification at baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Detection of Genotypic Resistance
Time Frame: Onetime identification at baseline
Detection of Genotypic Resistance (in-vitro antibiotic susceptibility test (AST) based on measuring minimum inhibitory concentration (MIC) or zone diameter (ZD))
Onetime identification at baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Basel, Switzerland

Collaborators

Swiss National Science Foundation

Investigators

  • Principal Investigator: Adrian Egli, Prof, Biozentrum, University of Basel

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 30, 2019

Primary Completion (Anticipated)

December 31, 2029

Study Completion (Anticipated)

December 31, 2029

Study Registration Dates

First Submitted

November 19, 2019

First Submitted That Met QC Criteria

November 19, 2019

First Posted (Actual)

November 21, 2019

Study Record Updates

Last Update Posted (Actual)

December 16, 2021

Last Update Submitted That Met QC Criteria

December 15, 2021

Last Verified

December 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2019-01291; qu19Egli5

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Multiresistant Bacterial Pathogens

Clinical Trials on Analysis of Bacterial Genome

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Egypt

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe