Clinical Comparison of Treatment Strategies in AmpC Beta-lactamase Producing Enterobacterales in a Swiss Tertiary Care Hospital (AmpCstratBasel)

Clinical Comparison of Treatment Strategies in AmpC Beta-lactamase Producing Enterobacterales in a Swiss Tertiary Care Hospital (AmpC-strat Basel)

This study is to investigate the recent epidemiological trends and the treatment outcome in terms of the length of hospital stay, the relevant renal and neurological side effects, risk factors for developing these side effects, the selection of more resistant pathogens under therapy as well as the incidence of Clostridium difficile infections under treatment.

Study Overview

• Status: Recruiting
• Conditions: Infection With AmpC Beta-lactamase Producing Enterobacterales
• Intervention / Treatment: Other: data collection

Detailed Description

Increasing resistance among Enterobacterales to beta-lactam antibiotics is globally a major concern in the antibiotic resistance crisis. In gram-negative bacteria it evolves primarily through the production of beta-lactamases that allow the rapid hydrolysis of common antibiotics - most notably 3rd generation cephalosporins. Particularly, the production of Ambler class C beta-lactamase (AmpC) is a very concerning and unique resistance mechanism as so called derepressed mutants can be induced during treatment. Information on recent epidemiological trends as well as comparative information about the treatment strategies (cefepime versus piperacillin/tazobactam versus carbapenems) for infections with AmpC-producing Enterobacterales in Switzerland is still lacking. This study is to investigate the recent epidemiological trends and the treatment outcome in terms of the length of hospital stay, the relevant renal and neurological side effects, risk factors for developing these side effects, the selection of more resistant pathogens under therapy as well as the incidence of Clostridium difficile infections under treatment.

• Study Type: Observational
• Enrollment (Anticipated): 800

Contacts and Locations

• Study Contact: Name: Sarah Tschudin Sutter, Prof. Dr. med.; Phone Number: +41 061 328 68 10; Email: sarah.tschudin@usb.ch
• Study Contact Backup: Name: Julia Herrmann; Email: julia.herrmann@usb.ch

Study Locations

• Switzerland
  • Basel, Switzerland, 4031
    • Recruiting
    • Division of Infectious Disease and Hospital Epidemiology, University Hospital Basel
    • Contact: Julia Herrmann; Email: julia.herrmann@usb.ch
    • Contact: Sarah Tschudin Sutter,, Prof. Dr. med.; Phone Number: +41 061 328 68 10; Email: sarah.tschudin@usb.ch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients treated in the inpatient setting at the University Hospital Basel from January 1st, 2015 until July 31st, 2020 with detection of AmpC beta-lactamase producing Enterobacterales

Description

Inclusion Criteria:

• Patients with detection of AmpC beta-lactamase producing Enterobacterales

  1. In a blood culture (any ward)
  2. In a clinical sample of the lower respiratory tract (only intensive care unit)

Exclusion Criteria:

• Patients with documented refusal of subsequent use of their data

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
descriptive analyses of demographic data in patients with detection of AmpC beta-lactamase producing Enterobacterales	collection of demographic data (age, gender, hospital admission and discharge date, length of stay, ICU-stay, hospitalization prior to current hospital stay, discharge destination, outcome, cause of death, travel); descriptive analyses summarized as counts	single time-point at baseline
descriptive analyses of clinical data in patients with detection of AmpC beta-lactamase producing Enterobacterales	descriptive analyses of clinical data (comorbidities, renal function, previous exposure to antibiotics and proton pump inhibitors, immunosuppressive treatment, date of diagnosis and type of infection with AmpC producing Enterobacterales) summarized as counts	single time-point at baseline
descriptive analyses of treatment data in patients with detection of AmpC beta-lactamase producing Enterobacterales	descriptive and comparative analyses of treatment data (empiric and definitive antibiotic therapy including dosage, date of initiation/ discontinuation and changes in antibiotic therapy, exposures to other antimicrobials, concomitant medication, side effects) summarized as counts	single time-point at baseline
descriptive analyses of microbiological data in patients with detection of AmpC beta-lactamase producing Enterobacterales	descriptive analyses of microbiological data Species of AmpC producing Enterobacterales, type of sample, date of sample, history of colonization or infection with any antibiotic resistant pathogen, Gram-staining of endotracheal aspirate or bronchoalveolar lavage (BAL), neutrophile and epitheliale cell count, results of culture from sputum, endotracheal aspirate, BAL or lung tissue) summarized as counts	single time-point at baseline

Collaborators and Investigators

• Sponsor: University Hospital, Basel, Switzerland
• Investigators: Principal Investigator: Sarah Tschudin Sutter, Prof. Dr. med., Division of Infectious Disease and Hospital Epidemiology,University Hospital Basel

Study record dates

Study Major Dates

• Study Start (Actual): December 14, 2020
• Primary Completion (Anticipated): December 1, 2022
• Study Completion (Anticipated): December 1, 2022

Study Registration Dates

• First Submitted: September 30, 2020
• First Submitted That Met QC Criteria: September 30, 2020
• First Posted (Actual): October 8, 2020

Study Record Updates

• Last Update Posted (Actual): July 27, 2022
• Last Update Submitted That Met QC Criteria: July 26, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: antibiotic resistance; piperacillin/tazobactam; cefepime; carbapenem; Ambler class C beta-lactamase (AmpC); carbapenem resistance; minimum inhibitory concentrations (MICs); Clostridium difficile infections; epidemiological trends
• Additional Relevant MeSH Terms: Infections
• Other Study ID Numbers: 2020-02251; me20TschudinSutter

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No