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Epidemiology of Carbapenemase-producing Bacteria in a Swiss Tertiary Care Hospital (CPB-Epi Basel)

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ClinicalTrials.gov Identifier: NCT04098133
Recruitment Status : Recruiting
First Posted : September 23, 2019
Last Update Posted : September 26, 2019
Sponsor:
Information provided by (Responsible Party):
University Hospital, Basel, Switzerland

Brief Summary:
This retrospective and prospective study is to investigate the incidence of Carbapenemase-producing bacteria (CPB) at the University Hospital Basel, the time to detection of CPB and to initiation of infection control measures, the risk factors associated with carriage of CPB, type and duration of previously administrated antibiotic medication, antibiotic treatment, as well as to assess the outcomes of the affected patients.

Condition or disease Intervention/treatment
Infections With CPB Other: data collection for demographic data Other: data collection for clinical data Other: data collection for treatment data Other: data collection for microbiological data

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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Other
Official Title: Epidemiology of Carbapenemase-producing Bacteria in a Swiss Tertiary Care Hospital
Actual Study Start Date : August 22, 2019
Estimated Primary Completion Date : June 30, 2029
Estimated Study Completion Date : June 30, 2029

Resource links provided by the National Library of Medicine



Intervention Details:
  • Other: data collection for demographic data
    data collection for demographic data (age, gender, hospital admission and discharge date, length of stay, hospitalization prior to current hospital stay (acute care facilities, long-term healthcare centres, nursing homes), discharge destination, outcome, cause of death, travel history, previous exposure to antibiotics and proton pump Inhibitors)
  • Other: data collection for clinical data
    data collection for clinical data (comorbidities, Charlson Comorbidity Index, immunosuppressive treatment, date of diagnosis of CPB, days between hospital admission and diagnosis of CPB, type of consecutive infection, indwelling vascular hardware, urinary catheterization, surgical therapies)
  • Other: data collection for treatment data
    data collection for treatment data (antibiotic therapy, immunosuppressive therapy, concomitant medication)
  • Other: data collection for microbiological data
    data collection for microbiological data (species of CPB, type of sample, date of sample, history of colonization or infection with any antibiotic resistant pathogen)


Primary Outcome Measures :
  1. incidence of CPB at the University Hospital Basel (number) [ Time Frame: from January 1st , 2008 until December 31st, 2028 ]
    incidence of CPB at the University Hospital Basel (number)


Secondary Outcome Measures :
  1. time to detection of CPB (days) [ Time Frame: from January 1st , 2008 until December 31st, 2028 ]
    time to detection of CPB (days)

  2. time to initiation of infection control measures [ Time Frame: from January 1st , 2008 until December 31st, 2028 ]
    time to initiation of infection control measures

  3. time to adequate treatment in patients with CPB infections [ Time Frame: from January 1st , 2008 until December 31st, 2028 ]
    time to adequate treatment in patients with CPB infections

  4. presence of established risk factors for CPB [ Time Frame: from January 1st , 2008 until December 31st, 2028 ]
    presence of established risk factors for CPB

  5. length of hospital stay (days) [ Time Frame: from January 1st , 2008 until December 31st, 2028 ]
    length of hospital stay (days)

  6. discharge destination [ Time Frame: from January 1st , 2008 until December 31st, 2028 ]
    discharge destination

  7. cure from infection [ Time Frame: from January 1st , 2008 until December 31st, 2028 ]
    cure from infection

  8. cause-specific mortality (number) [ Time Frame: from January 1st , 2008 until December 31st, 2028 ]
    cause-specific mortality (number)

  9. all-cause mortality (number) [ Time Frame: from January 1st , 2008 until December 31st, 2028 ]
    all-cause mortality (number)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients treated in the in- or outpatient setting at the University Hospital Basel with detection of carbapenemase-producing bacteria in any screening or clinical sample from January 1st , 2008 until December 31st , 2028
Criteria

Inclusion Criteria:

  • Patients with detection of carbapenemase-producing bacteria from January 1st , 2008 until December 31st , 2028

Exclusion Criteria:

  • Patients with documented refusal of subsequent use of their data

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04098133


Contacts
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Contact: Sarah Tschudin Sutter, Prof. Dr. MD +41 61 328 68 10 sarah.tschudin@usb.ch
Contact: Isabelle Vock, Dipl. med isabelle.vock@usb.ch

Locations
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Switzerland
Division of Infectious Diseases and Hospital Epidemiology Recruiting
Basel, Switzerland, 4031
Contact: Sarah Tschudin Sutter, PD MD    +41 61 328 68 10    sarah.tschudin@usb.ch   
Sub-Investigator: Isabelle Vock, Dipl. med.         
Sponsors and Collaborators
University Hospital, Basel, Switzerland
Investigators
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Principal Investigator: Sarah Tschudin Sutter, Prof. Dr. MD University Hospital Basel, Division of Infectious Diseases and Hospital Epidemiology
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Responsible Party: University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier: NCT04098133    
Other Study ID Numbers: 2019-01548; me19Tschudinsutter
First Posted: September 23, 2019    Key Record Dates
Last Update Posted: September 26, 2019
Last Verified: September 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Basel, Switzerland:
Carbapenemase-producing Klebsiella pneumoniae
antibiotic resistancy
infections with Carbapenemase-producing Bacteria (CPB)
Carbapenemase-producing Bacteria
Additional relevant MeSH terms:
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Infection