Multiresistant Bacterial PathogensNCT04172025
Development of a Swiss Surveillance Database for Molecular Epidemiology of Hypervirulent and Multi-drug Resistant Pathogens
An observational study of Multiresistant Bacterial Pathogens and Virulent Bacterial Pathogens, run by University Hospital, Basel, Switzerland at 5 sites in Switzerland.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Multiresistant Bacterial Pathogens, Virulent Bacterial Pathogens
- What is being tested?
- Analysis of Bacterial Genome
- How many people
- 10,000 participants
- Where
- 5 sitesSwitzerland
- Study dates
- 30 Sep 2019to 31 Dec 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- Decline to sign a general consent or any other declining statement against using data for research purposes.
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Aitana Lebrand, Dr. contact
5 sites in 1 country
Switzerland5 sites, 5 recruiting
- Recruiting
University Hospital Basel
Basel, 4031
Hans Hirsch, Prof. Dr., +41 61 32 86697, hans.hirsch@unibas.ch
Hans Hirsch, Prof. Dr.
- Recruiting
University of Bern
Bern, 3012
Vincent Perreten, Prof.
Stephen Leib, Prof.
- Recruiting
University Hospital Geneva
Geneva, 1205
Jacques Schrenzel, Prof.
Laurent Kaiser, Prof.
- Recruiting
University Hospital Lausanne CHUV
Lausanne, 1011
Gilbert Greub, Prof.
Dominique Blanc, PD Dr.
- Recruiting
University of Zurich
Zurich, 8057
Michael Huber, Dr.
Roger Stephan, Prof.
About this study
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.
Read the 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.
- Being tested
- Analysis of Bacterial Genome
- Keywords
- Epidemiology, surveillance, bacterial pathogens, Database, Genotyping
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Analysis of Bacterial GenomeDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Diagnostic Test: Analysis of Bacterial Genome |
What is being measured
The primary outcome is the main question the study is designed to answer.
Identification of transmission clusters based on genetic similarity.
Identification of transmission clusters based on genetic similarity. With focus on whole genome sequencing.
Measured: Onetime identification at baseline
Secondary outcomes (1)
Detection of Genotypic Resistance
Detection of Genotypic Resistance (in-vitro antibiotic susceptibility test (AST) based on measuring minimum inhibitory concentration (MIC) or zone diameter (ZD))
Measured: Onetime identification at baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2019
- Study start30 Sep 2019
- Primary completion31 Dec 2029 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Multiresistant Bacterial PathogensStudies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 10,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Collaborators
- Swiss National Science Foundation
- Responsible party
- Sponsor
- Investigators
- Hans Hirsch, Prof. Dr., Principal investigator, Biozentrum, University of Basel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04172025
- Sponsor's protocol ID
- 2019-01291; qu19Egli5
- Other IDs
- 2019
- Status last verified
- May 2025
- First submitted
- 19 Nov 2019
- Last updated
- 14 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Cassini A, Hogberg LD, Plachouras D, Quattrocchi A, Hoxha A, Simonsen GS, Colomb-Cotinat M, Kretzschmar ME, Devleesschauwer B, Cecchini M, Ouakrim DA, Oliveira TC, Struelens MJ, Suetens C, Monnet DL; Burden of AMR Collaborative Group. Attributable deaths and disability-adjusted life-years caused by infections with antibiotic-resistant bacteria in the EU and the European Economic Area in 2015: a population-level modelling analysis. Lancet Infect Dis. 2019 Jan;19(1):56-66. doi: 10.1016/S1473-3099(18)30605-4. Epub 2018 Nov 5.
PubMed 30409683Daxboeck F, Budic T, Assadian O, Reich M, Koller W. Economic burden associated with multi-resistant Gram-negative organisms compared with that for methicillin-resistant Staphylococcus aureus in a university teaching hospital. J Hosp Infect. 2006 Feb;62(2):214-8. doi: 10.1016/j.jhin.2005.07.009. Epub 2005 Oct 27.
PubMed 16257092Egli A, Blanc DS, Greub G, Keller PM, Lazarevic V, Lebrand A, Leib S, Neher RA, Perreten V, Ramette A, Schrenzel J, Stephan R, Wagner K, Wuethrich D, Xenarios I. Improving the quality and workflow of bacterial genome sequencing and analysis: paving the way for a Switzerland-wide molecular epidemiological surveillance platform. Swiss Med Wkly. 2018 Dec 15;148:w14693. doi: 10.4414/smw.2018.14693. eCollection 2018 Dec 3.
PubMed 30552858Ford L, Carter GP, Wang Q, Seemann T, Sintchenko V, Glass K, Williamson DA, Howard P, Valcanis M, Castillo CFS, Sait M, Howden BP, Kirk MD. Incorporating Whole-Genome Sequencing into Public Health Surveillance: Lessons from Prospective Sequencing of Salmonella Typhimurium in Australia. Foodborne Pathog Dis. 2018 Mar;15(3):161-167. doi: 10.1089/fpd.2017.2352. Epub 2018 Jan 16.
PubMed 29336594Meinel DM, Kuehl R, Zbinden R, Boskova V, Garzoni C, Fadini D, Dolina M, Blumel B, Weibel T, Tschudin-Sutter S, Widmer AF, Bielicki JA, Dierig A, Heininger U, Konrad R, Berger A, Hinic V, Goldenberger D, Blaich A, Stadler T, Battegay M, Sing A, Egli A. Outbreak investigation for toxigenic Corynebacterium diphtheriae wound infections in refugees from Northeast Africa and Syria in Switzerland and Germany by whole genome sequencing. Clin Microbiol Infect. 2016 Dec;22(12):1003.e1-1003.e8. doi: 10.1016/j.cmi.2016.08.010. Epub 2016 Aug 30.
PubMed 27585943Phodha T, Riewpaiboon A, Malathum K, Coyte PC. Excess annual economic burdens from nosocomial infections caused by multi-drug resistant bacteria in Thailand. Expert Rev Pharmacoecon Outcomes Res. 2019 Jun;19(3):305-312. doi: 10.1080/14737167.2019.1537123. Epub 2018 Oct 19.
PubMed 30321493Seth-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.
PubMed 31107229Sommerstein 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.
PubMed 29233255Stucki 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.
PubMed 27194683Walker 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.
PubMed 29326013Ward 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.
PubMed 31012399Wassilew 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.
PubMed 30043725Wuthrich 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.
PubMed 30696527
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a Swiss Surveillance Database for Molecular Epidemiology of Hypervirulent and Multi-drug Resistant Pathogens
- ClinicalTrials.gov ID
- NCT04172025
- Acronym / sponsor ID
- 2019-01291; qu19Egli5
- Keywords
- Epidemiology, surveillance, bacterial pathogens, Database, Genotyping
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 10,000 participants (estimated)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Collaborators
- Swiss National Science Foundation
- Study start
- 30 Sep 2019 (actual)
- Primary completion
- 31 Dec 2029 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 21 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with colonization or infections with a pathogen | – | Diagnostic Test: Analysis of Bacterial GenomeAll 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 |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- Decline to sign a general consent or any other declining statement against using data for research purposes.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Analysis of Bacterial Genomegenome 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. | Diagnostic test | Patients with colonization or infections with a pathogen |
Primary outcome
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.
1 secondary outcome
Detection of Genotypic Resistance
Time frame: Onetime identification at baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2025.
- Background: PubMed 30409683Cassini A, Hogberg LD, Plachouras D, Quattrocchi A, Hoxha A, Simonsen GS, Colomb-Cotinat M, Kretzschmar ME, Devleesschauwer B, Cecchini M, Ouakrim DA, Oliveira TC, Struelens MJ, Suetens C, Monnet DL; Burden of AMR Collaborative Group. Attributable deaths and disability-adjusted life-years caused by infections with antibiotic-resistant bacteria in the EU and the European Economic Area in 2015: a population-level modelling analysis. Lancet Infect Dis. 2019 Jan;19(1):56-66. doi: 10.1016/S1473-3099(18)30605-4. Epub 2018 Nov 5.
- Background: PubMed 16257092Daxboeck F, Budic T, Assadian O, Reich M, Koller W. Economic burden associated with multi-resistant Gram-negative organisms compared with that for methicillin-resistant Staphylococcus aureus in a university teaching hospital. J Hosp Infect. 2006 Feb;62(2):214-8. doi: 10.1016/j.jhin.2005.07.009. Epub 2005 Oct 27.
- Background: PubMed 30552858Egli A, Blanc DS, Greub G, Keller PM, Lazarevic V, Lebrand A, Leib S, Neher RA, Perreten V, Ramette A, Schrenzel J, Stephan R, Wagner K, Wuethrich D, Xenarios I. Improving the quality and workflow of bacterial genome sequencing and analysis: paving the way for a Switzerland-wide molecular epidemiological surveillance platform. Swiss Med Wkly. 2018 Dec 15;148:w14693. doi: 10.4414/smw.2018.14693. eCollection 2018 Dec 3.
- Background: PubMed 29336594Ford L, Carter GP, Wang Q, Seemann T, Sintchenko V, Glass K, Williamson DA, Howard P, Valcanis M, Castillo CFS, Sait M, Howden BP, Kirk MD. Incorporating Whole-Genome Sequencing into Public Health Surveillance: Lessons from Prospective Sequencing of Salmonella Typhimurium in Australia. Foodborne Pathog Dis. 2018 Mar;15(3):161-167. doi: 10.1089/fpd.2017.2352. Epub 2018 Jan 16.
- Background: PubMed 27585943Meinel DM, Kuehl R, Zbinden R, Boskova V, Garzoni C, Fadini D, Dolina M, Blumel B, Weibel T, Tschudin-Sutter S, Widmer AF, Bielicki JA, Dierig A, Heininger U, Konrad R, Berger A, Hinic V, Goldenberger D, Blaich A, Stadler T, Battegay M, Sing A, Egli A. Outbreak investigation for toxigenic Corynebacterium diphtheriae wound infections in refugees from Northeast Africa and Syria in Switzerland and Germany by whole genome sequencing. Clin Microbiol Infect. 2016 Dec;22(12):1003.e1-1003.e8. doi: 10.1016/j.cmi.2016.08.010. Epub 2016 Aug 30.
- Background: PubMed 30321493Phodha T, Riewpaiboon A, Malathum K, Coyte PC. Excess annual economic burdens from nosocomial infections caused by multi-drug resistant bacteria in Thailand. Expert Rev Pharmacoecon Outcomes Res. 2019 Jun;19(3):305-312. doi: 10.1080/14737167.2019.1537123. Epub 2018 Oct 19.
- Background: PubMed 31107229Seth-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.
- Background: PubMed 29233255Sommerstein 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.
- Background: PubMed 27194683Stucki 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.
- Background: PubMed 29326013Walker 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.
- Background: PubMed 31012399Ward 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.
- Background: PubMed 30043725Wassilew 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Aitana Lebrand, Dr. contact
Hans Hirsch, Prof. Dr. principal investigator
Biozentrum, University of Basel
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiresistant Bacterial Pathogens and Virulent Bacterial Pathogens, run by University Hospital, Basel, Switzerland at 5 sites in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hans Hirsch, Prof. Dr. (+41 61 32 86697, hans.hirsch@unibas.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Identification of transmission clusters based on genetic similarity. (time frame: Onetime identification at baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04172025, which also lists 13 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2025.