NCT04577989

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
270

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2020

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 30, 2020

Completed
8 days until next milestone

First Posted

Study publicly available on registry

October 8, 2020

Completed
2 months until next milestone

Study Start

First participant enrolled

December 14, 2020

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 19, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 19, 2022

Completed
Last Updated

February 1, 2023

Status Verified

January 1, 2023

Enrollment Period

2 years

First QC Date

September 30, 2020

Last Update Submit

January 31, 2023

Conditions

Infection With AmpC Beta-lactamase Producing Enterobacterales

Keywords

antibiotic resistanceAmbler class C beta-lactamase (AmpC)carbapenem resistanceminimum inhibitory concentrations (MICs)cefepimepiperacillin/tazobactamcarbapenemClostridium difficile infectionsepidemiological trends

Outcome Measures

Primary Outcomes (4)

  • 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

Interventions

data collectionOTHER

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.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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

You may qualify if:

  • 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)

You may not qualify if:

  • Patients with documented refusal of subsequent use of their data

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Division of Infectious Disease and Hospital Epidemiology, University Hospital Basel

Basel, 4031, Switzerland

Location

MeSH Terms

Conditions

Clostridium Infections

Interventions

Data Collection

Condition Hierarchy (Ancestors)

Gram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfections

Intervention Hierarchy (Ancestors)

Epidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Sarah Tschudin Sutter, Prof. Dr. med.

    Division of Infectious Disease and Hospital Epidemiology,University Hospital Basel

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 30, 2020

First Posted

October 8, 2020

Study Start

December 14, 2020

Primary Completion

December 19, 2022

Study Completion

December 19, 2022

Last Updated

February 1, 2023

Record last verified: 2023-01

Locations

CH(1)