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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Infection With AmpC Beta-lactamase Producing Enterobacterales

Intervention / Treatment
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* Other: data collection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with detection of AmpC beta-lactamase producing Enterobacterales In a blood culture (any ward) 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: data collection|data collection for treatment strategies (cefepime vs. piperacillin/tazobactam vs. carbapenems) of infections caused by AmpC beta-lactamase producing Enterobacterales for the period January 1st , 2015 until July 31st , 2020.|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cefepime, antibiotic resistance, Ambler class C beta-lactamase (AmpC), carbapenem resistance, minimum inhibitory concentrations (MICs), piperacillin/tazobactam, carbapenem, Clostridium difficile infections, epidemiological trends