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

Completed

• Conditions: Infection With AmpC Beta-lactamase Producing Enterobacterales

• Registration Number: NCT04577989
• Lead Sponsor: University Hospital, Basel, Switzerland

Brief Summary

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.

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 Timeline

• Study First Submitted: 2020-09-30
• Study First Submitted QC: 2020-09-30
• Study First Posted: 2020-10-08
• Study Start: 2020-12-14
• Primary Completion: 2022-12-19
• Study Completion: 2022-12-19
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-31
• Last Update Posted: 2023-02-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 270

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
descriptive analyses of demographic data in patients with detection of AmpC beta-lactamase producing Enterobacterales	single time-point at baseline	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
descriptive analyses of microbiological data in patients with detection of AmpC beta-lactamase producing Enterobacterales	single time-point at baseline	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
descriptive analyses of treatment data in patients with detection of AmpC beta-lactamase producing Enterobacterales	single time-point at baseline	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
descriptive analyses of clinical data in patients with detection of AmpC beta-lactamase producing Enterobacterales	single time-point at baseline	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

Trial Locations

Locations (1)

Division of Infectious Disease and Hospital Epidemiology, University Hospital Basel; 🇨🇭 Basel, Switzerland