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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04098133
Other study ID # 2019-01548; me19Tschudinsutter
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date August 22, 2019
Est. completion date June 30, 2029

Study information

Verified date September 2023
Source University Hospital, Basel, Switzerland
Contact Sarah Tschudin Sutter, Prof. Dr. MD
Phone +41 61 328 68 10
Email sarah.tschudin@usb.ch
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 100
Est. completion date June 30, 2029
Est. primary completion date June 30, 2029
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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)
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)
data collection for treatment data
data collection for treatment data (antibiotic therapy, immunosuppressive therapy, concomitant medication)
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)

Locations

Country Name City State
Switzerland Division of Infectious Diseases and Hospital Epidemiology Basel

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Basel, Switzerland

Country where clinical trial is conducted

Switzerland, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 time to detection of CPB (days) time to detection of CPB (days) from January 1st , 2008 until December 31st, 2028
Secondary time to initiation of infection control measures time to initiation of infection control measures from January 1st , 2008 until December 31st, 2028
Secondary 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
Secondary presence of established risk factors for CPB presence of established risk factors for CPB from January 1st , 2008 until December 31st, 2028
Secondary length of hospital stay (days) length of hospital stay (days) from January 1st , 2008 until December 31st, 2028
Secondary discharge destination discharge destination from January 1st , 2008 until December 31st, 2028
Secondary cure from infection cure from infection from January 1st , 2008 until December 31st, 2028
Secondary cause-specific mortality (number) cause-specific mortality (number) from January 1st , 2008 until December 31st, 2028
Secondary all-cause mortality (number) all-cause mortality (number) from January 1st , 2008 until December 31st, 2028