Clinical trial NCT04577989: Clinical Comparison of Treatment Strategies in AmpC Beta-lactamase Producing Enterobacterales in a Swiss Tertiary Care Hospital
Official title: Clinical Comparison of Treatment Strategies in AmpC Beta-lactamase Producing Enterobacterales in a Swiss Tertiary Care Hospital (AmpC-strat Basel)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Infection With AmpC Beta-lactamase Producing Enterobacterales
Keywords: antibiotic resistance
Ambler class C beta-lactamase (AmpC)
carbapenem resistance
minimum inhibitory concentrations (MICs)
cefepime
piperacillin/tazobactam
carbapenem
Clostridium difficile infections
epidemiological trends
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
First posted: 2020-10-08
Enrollment: 270
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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

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.

Eligibility criteria: 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

Primary outcomes:
measure: descriptive analyses of demographic data in patients with detection of AmpC beta-lactamase producing Enterobacterales
timeFrame: single time-point at baseline
measure: descriptive analyses of clinical data in patients with detection of AmpC beta-lactamase producing Enterobacterales
timeFrame: single time-point at baseline
measure: descriptive analyses of treatment data in patients with detection of AmpC beta-lactamase producing Enterobacterales
timeFrame: single time-point at baseline
measure: descriptive analyses of microbiological data in patients with detection of AmpC beta-lactamase producing Enterobacterales
timeFrame: single time-point at baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: Division of Infectious Disease and Hospital Epidemiology, University Hospital Basel
Study officials:
affiliation: Division of Infectious Disease and Hospital Epidemiology,University Hospital Basel
name: Sarah Tschudin Sutter, Prof. Dr. med.
role: PRINCIPAL_INVESTIGATOR
References: