NCT04098133

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.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
37mo left

Started Aug 2019

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress69%
Aug 2019Jun 2029

Study Start

First participant enrolled

August 22, 2019

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

September 17, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 23, 2019

Completed
9.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2029

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2029

Last Updated

June 8, 2026

Status Verified

June 1, 2026

Enrollment Period

9.9 years

First QC Date

September 17, 2019

Last Update Submit

June 4, 2026

Conditions

Keywords

Carbapenemase-producing Klebsiella pneumoniaeantibiotic resistancyinfections with Carbapenemase-producing Bacteria (CPB)Carbapenemase-producing Bacteria

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (9)

  • time to detection of CPB (days)

    from January 1st , 2008 until December 31st, 2028

  • time to initiation of infection control measures

    from January 1st , 2008 until December 31st, 2028

  • time to adequate treatment in patients with CPB infections

    from January 1st , 2008 until December 31st, 2028

  • presence of established risk factors for CPB

    from January 1st , 2008 until December 31st, 2028

  • length of hospital stay (days)

    from January 1st , 2008 until December 31st, 2028

  • +4 more secondary outcomes

Interventions

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 (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 (antibiotic therapy, immunosuppressive therapy, concomitant medication)

data collection for microbiological data (species of CPB, type of sample, date of sample, history of colonization or infection with any antibiotic resistant pathogen)

Eligibility Criteria

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

You may qualify if:

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

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 Diseases and Hospital Epidemiology

Basel, 4031, Switzerland

RECRUITING

MeSH Terms

Interventions

Data CollectionDemography

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Sarah Tschudin Sutter, Prof. Dr. MD

    University Hospital Basel, Division of Infectious Diseases and Hospital Epidemiology

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sarah Tschudin Sutter, Prof. Dr. MD

CONTACT

Isabelle Vock, Dipl. med

CONTACT

Study Design

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

Study Record Dates

First Submitted

September 17, 2019

First Posted

September 23, 2019

Study Start

August 22, 2019

Primary Completion (Estimated)

June 30, 2029

Study Completion (Estimated)

June 30, 2029

Last Updated

June 8, 2026

Record last verified: 2026-06

Locations