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

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.

Study Overview

• Status: Recruiting
• Conditions: Infections With CPB
• Intervention / Treatment: Other: data collection for demographic data; Other: data collection for clinical data; Other: data collection for treatment data; Other: data collection for microbiological data

• Study Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

• Study Contact: Name: Sarah Tschudin Sutter, Prof. Dr. MD; Phone Number: +41 61 328 68 10; Email: sarah.tschudin@usb.ch
• Study Contact Backup: Name: Isabelle Vock, Dipl. med; Email: isabelle.vock@usb.ch

Study Locations

• Switzerland
  • Basel, Switzerland, 4031
    • Recruiting
    • Division of Infectious Diseases and Hospital Epidemiology
    • Contact: Sarah Tschudin Sutter, PD MD; Phone Number: +41 61 328 68 10; Email: sarah.tschudin@usb.ch
    • Sub-Investigator: Isabelle Vock, Dipl. med.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• 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

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
incidence of CPB at the University Hospital Basel (number)	incidence of CPB at the University Hospital Basel (number)	from January 1st , 2008 until December 31st, 2028

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
time to detection of CPB (days)	time to detection of CPB (days)	from January 1st , 2008 until December 31st, 2028
time to initiation of infection control measures	time to initiation of infection control measures	from January 1st , 2008 until December 31st, 2028
time to adequate treatment in patients with CPB infections	time to adequate treatment in patients with CPB infections	from January 1st , 2008 until December 31st, 2028
presence of established risk factors for CPB	presence of established risk factors for CPB	from January 1st , 2008 until December 31st, 2028
length of hospital stay (days)	length of hospital stay (days)	from January 1st , 2008 until December 31st, 2028
discharge destination	discharge destination	from January 1st , 2008 until December 31st, 2028
cure from infection	cure from infection	from January 1st , 2008 until December 31st, 2028
cause-specific mortality (number)	cause-specific mortality (number)	from January 1st , 2008 until December 31st, 2028
all-cause mortality (number)	all-cause mortality (number)	from January 1st , 2008 until December 31st, 2028

Collaborators and Investigators

• Sponsor: University Hospital, Basel, Switzerland
• Investigators: Principal Investigator: Sarah Tschudin Sutter, Prof. Dr. MD, University Hospital Basel, Division of Infectious Diseases and Hospital Epidemiology

Study record dates

Study Major Dates

• Study Start (Actual): August 22, 2019
• Primary Completion (Estimated): June 30, 2029
• Study Completion (Estimated): June 30, 2029

Study Registration Dates

• First Submitted: September 17, 2019
• First Submitted That Met QC Criteria: September 17, 2019
• First Posted (Actual): September 23, 2019

Study Record Updates

• Last Update Posted (Actual): December 13, 2024
• Last Update Submitted That Met QC Criteria: December 12, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: Carbapenemase-producing Klebsiella pneumoniae; antibiotic resistancy; infections with Carbapenemase-producing Bacteria (CPB); Carbapenemase-producing Bacteria
• Additional Relevant MeSH Terms: Infections
• Other Study ID Numbers: 2019-01548; me19Tschudinsutter

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No