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Completed

NCT Number: NCT04577989

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

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.

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Key information

Conditions

Infection With AmpC Beta-lactamase Producing Enterobacterales Bacterial Infections Bacterial Infections and Mycoses Clostridium Infections Gram-Positive Bacterial Infections Infections

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Division of Infectious Disease and Hospital Epidemiology, University Hospital Basel

Basel, 4031, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Data Collection

Other

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.

Primary outcomes

  1. descriptive analyses of demographic data in patients with detection of AmpC beta-lactamase producing Enterobacterales

    Time frame: 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

  2. descriptive analyses of clinical data in patients with detection of AmpC beta-lactamase producing Enterobacterales

    Time frame: 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

  3. descriptive analyses of treatment data in patients with detection of AmpC beta-lactamase producing Enterobacterales

    Time frame: 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

  4. descriptive analyses of microbiological data in patients with detection of AmpC beta-lactamase producing Enterobacterales

    Time frame: 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

Sponsors and collaborators

Lead sponsor

University Hospital, Basel, Switzerland

Other

Registry information

Official study title

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

Acronym: AmpCstratBasel

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Oct 8, 2020
Registry last updated
Feb 1, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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