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TerminatedNCT04323553PFGE-WGSUpdated Jan 15, 2025

Comparison of Pulsed-field Gel Electrophoresis and Whole Genome Sequencing to Determine Transmission Rate of ESBL-producing E.Coli

An observational study in Analysis Transmission Rate, sponsored by University Hospital, Basel, Switzerland. Terminated at 1 site in Switzerland. Per ClinicalTrials.gov, last updated 2025-01-15.

Sponsored by University Hospital, Basel, Switzerland · Observational

Why this study was terminated
This study is no longer of interested as one of the technology used is already outdated.
Study type
Observational
Model
Other
Time perspective
Retrospective
Enrollment
43
Sex
All
01

Study summary

The aim of this quality control study is to compare two different techniques to determine ESBL-producing E.coli transmission.

Read the detailed description

Pulse-field gel electrophoresis (PFGE) was considered the reference standard to determine transmission events of extended-spectrum Beta-Lactamase (ESBL) producing E.coli . However, this technique lacks the resolution to differentiate closely related strains, which is needed to identify ESBL-transmission. Furthermore, PFGE is not able to distinguish mobile genetic elements. In contrast, whole genome sequencing (WGS) allows the identification of single-nucleotide polymorphisms (SNPs) that differentiate bacterial strains and mobile genetic elements, such as plasmids at the highest possible resolution, therefore enabling investigation of their relatedness by phylogenetic analyses and ultimately detailed exploration of transmission pathways. As WGS is now readily available and affordable, the investigators aim to reinvestigate transmission events in the 24 index-contact patient-pairs identified after cessation of contact precautions by reassessing the genetic relatedness of both strains and mobile genetic elements by sequencing all 48 recovered ESBL- E.coli strains.

The investigators hypothesize that the number of transmission events as defined by transmission of ESBL-producing E. coli strains may have been overestimated by PFGE as compared to WGS, as PFGE lacks the resolution to differentiate closely related strains. However, transmission of mobile genetic elements may have been missed by PFGE as this technology is not able to identify the genetic relatedness of plasmids, genes and other mobile genetic elements. Thus WGS may reveal additional transmission events defined as the transmission of mobile genetic elements.

Different sequencing approaches may yield different results in terms of detection of transmission events.

The investigators hypothesize that short-read sequencing may suffice to reliably detect relatedness of strains but that additional long-read sequencing approaches are needed to detect transmission of mobile genetic elements.

02

Conditions studied

  • Analysis Transmission Rate
03

In context

Lead sponsor

University Hospital, Basel, Switzerland is the lead sponsor of 968 studies on the registry; 191 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

The patient population is defined as the 24 contact-index patient pairs identified during screening of contact patients after cessation of contact precautions during June 2012 to December 2013 at the University Hospital Basel and from January 2012 to December 2013 at the FELIX PLATTER-Hospital.

Inclusion criteria

  • The patient population is defined as the 24 contact-index patient pairs identified during screening of contact patients after cessation of contact precautions as part of a quality control, performed from June 2012 to December 2013 at the University Hospital Basel and from January 2012 to December 2013 at the FELIX PLATTER-Hospital.

Exclusion criteria

Exclusion Criteria:

  • Patients not meeting the above mentioned inclusion criteria.
05

Study design

Observational model
Other
Time perspective
Retrospective
Enrollment
43 participants (actual)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • ESBL E.coli strains from 24 contact-index patients

    48 ESBL-E. coli strains from 24 contact-index patients

    Diagnostic Test: Pulsed-field gel electrophoresis and whole genome sequencing · Other: Data collection

Interventions

  • Diagnostic testPulsed-field gel electrophoresis and whole genome sequencing

    Comparison of the two different techniques

  • OtherData collection

    Demographic data (age, gender, hospital admission and discharge date, rooms and wards with dates of admission and discharge, hospitalization prior to current hospital stay, discharge destination, outcome, cause of death, travel history, recent hospitalization in an ESBL-high burden region, admission from another healthcare facility, admission from a long-term care facility, occupational or household contact to animals) Clinical data (date of diagnosis of ESBL-producing E. coli carriage, type of infection/colonization with ESBL- producing E. coli, comorbidities, Charlson Comorbidity Index, infectious diseases after detection of ESBL-PE, active open wounds, indwelling vascular devices, urinary catheterization) Treatment data (Immunosuppression, antibiotic therapy, concomitant medication and surgical therapy prior to and during hospital stay) Microbiological data

06

What researchers measure

Primary outcomes

  1. Number of transmission events as determined by WGS

    Transmission events will be categorized into transmission of strains and transmission of mobile genetic elements. The number of transmission events as determined by WGS will be compared to the number of transmission events as determined by PFGE. Patient-related characteristics and exposures will be compared between patients with and without transmission events.

    Time frame: January 2012- December 2020

07

Study locations

1 site
  • University Hospital Basel, Division of Infectious Diseases and Hospital Epidemiology
    Basel, 4031, Switzerland
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 15, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04323553
Lead sponsor
University Hospital, Basel, Switzerland
Responsible party
Sponsor
First posted
Mar 26, 2020
Start date
Mar 6, 2020
Primary completion
Jan 7, 2025
Completion
Jan 7, 2025
Last update
Jan 15, 2025

Study contacts

Sarah Tschudin Sutter, Prof. Dr. MD
principal investigator · University Hospital, Basel, Switzerland

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.

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