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

NCT ID: NCT04577989

Last Updated: 2023-02-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

270 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-12-14

Study Completion Date

2022-12-19

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.

Conditions

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Infection With AmpC Beta-lactamase Producing Enterobacterales

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Basel, Switzerland

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sarah Tschudin Sutter, Prof. Dr. med.

Role: PRINCIPAL_INVESTIGATOR

Division of Infectious Disease and Hospital Epidemiology,University Hospital Basel

Locations

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Division of Infectious Disease and Hospital Epidemiology, University Hospital Basel

Basel, , Switzerland

Site Status

Countries

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Switzerland

Other Identifiers

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2020-02251; me20TschudinSutter

Identifier Type: -

Identifier Source: org_study_id

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