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

NCT04323553 | Terminated

• 1 other identifier: 2020-00188
• Study Type: observational
• Target: 43
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Analysis Transmission Rate

Outcome Measures

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.

  January 2012- December 2020

Study Arms (1)

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

Pulsed-field gel electrophoresis and whole genome sequencing DIAGNOSTIC_TEST

Comparison of the two different techniques

ESBL E.coli strains from 24 contact-index patients

Data collection OTHER

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

ESBL E.coli strains from 24 contact-index patients

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Basel, Switzerland: lead

Study Sites (1)

University Hospital Basel, Division of Infectious Diseases and Hospital Epidemiology

Basel, 4031, Switzerland

Location

Biospecimen

Retention: SAMPLES WITH DNA

Enterobacteriaceae

MeSH Terms

Interventions

Data Collection

Intervention Hierarchy (Ancestors)

Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Sarah Tschudin Sutter, Prof. Dr. MD

  University Hospital, Basel, Switzerland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 24, 2020
• First Posted: March 26, 2020
• Study Start: March 6, 2020
• Primary Completion: January 7, 2025
• Study Completion: January 7, 2025
• Last Updated: January 15, 2025

Record last verified: 2025-01

Locations

CH (1)