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

Infection With AmpC Beta-lactamase Producing Enterobacterales Clinical Trial

— AmpCstratBasel  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04577989
• Other study ID #: 2020-02251; me20TschudinSutter
• Status: Completed
• Start date: December 14, 2020
• Est. completion date: December 19, 2022

Study information

• Verified date: January 2023
• Source: University Hospital, Basel, Switzerland
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 270
• Est. completion date: December 19, 2022
• Est. primary completion date: December 19, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Infection With AmpC Beta-lactamase Producing Enterobacterales
• Infections

Intervention

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.

Locations

Country	Name	City	State
Switzerland	Division of Infectious Disease and Hospital Epidemiology, University Hospital Basel	Basel

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Basel, Switzerland

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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