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Antibiotic Stewardship and Infection Control in Patients at High Risk of Developing Infection by Clostridium Difficile, Vancomycin-Resistant Enterococci or Multi-Resistant Gram-Negatives (ABSOLUTE)

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ClinicalTrials.gov Identifier: NCT03250104
Recruitment Status : Recruiting
First Posted : August 15, 2017
Last Update Posted : October 16, 2018
Sponsor:
Collaborators:
Charite University, Berlin, Germany
University Hospital Freiburg
University of Hamburg
University Hospital Lübeck
University Hospital Tuebingen
Information provided by (Responsible Party):
Dr. med. Jörg Janne Vehreschild, University Hospital of Cologne

Brief Summary:

Throughout project, the investigators design, evaluate and disseminate infection control and antibiotic stewardship (ABS) measures aimed at reducing the incidence of Clostridium difficile infection (CDI). The measures will focus on known departments with high incidence of CDI, i.e. a) hematology/oncology, b) other departments/wards demonstrating above-average infection rates, which were identified throughout previous studies. The infection control package will include staff training, hand hygiene programs and disinfection measures. Throughout the ABS package, investigators will develop and implement ABS measures specifically designed for patients at the highest risk of developing hospital-acquired infections, i.e. those treated on hematological/oncological wards. Potentially useful ABS actions even in critically ill patients are early reduction of exposure based on microbiological results, timely cessation of anti-infective treatment, thoughtful implementation of screening measures and biomarkers, defined approaches to patients known to be allergic to penicillins, and vigorous enforcement of clinical and microbiological diagnosis of infection focus.

The IC and ABS measures aim at educating and assisting clinical personnel in realizing treatments according to official guidelines. There will not be a direct contact between study personnel and patient. There will be no direct recruitment of patients.


Condition or disease Intervention/treatment
Clostridium Difficile Infection VRE Infection Nosocomial Infection MRGN Bacteria Other: Infection Control Other: Antibiotic Stewardship

  Show Detailed Description

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Study Type : Observational
Estimated Enrollment : 80000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Antibiotic Stewardship and Infection Control in Patients at High Risk of Developing Infection by Clostridium Difficile, Vancomycin-Resistant Enterococci or Multi-Resistant Gram-Negatives
Actual Study Start Date : November 2016
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Vancomycin


Intervention Details:
  • Other: Infection Control
    The infection control bundle will include staff training, hand hygiene programs, disinfection measures, and contact isolation. Physicians will be discouraged to prescribe proton pump inhibitors (PPIs) where not explicitly needed. The intervention bundle will be defined based on current literature. For implementation, the investigator will adapt the bundle to specific local needs, discuss with the responsible department heads and ward staff, perform training and disseminate standards of care.
  • Other: Antibiotic Stewardship
    Antibiotic stewards will develop local standards of procedure based on the provided training and guidelines. They will then train the responsible staff and disseminate guidelines as best suited for the local work environment, e.g. as pocket cards, posters, or electronically. Point-prevalence investigations and "antibiotic visits" will assure adherence to guidelines.


Primary Outcome Measures :
  1. CDI incidence [ Time Frame: Baseline and every 3 months up to 144 weeks ]
    Significant reduction of the overall CDI incidence on intervention wards following implementation of the combined IC and ABS bundles in pre-post analysis stratified by center.


Secondary Outcome Measures :
  1. Effectiveness of IC bundle through incidence of CDI or BSI by VRE and MRGN [ Time Frame: Baseline and every 3 months up to 144 weeks ]
    Effectiveness of the infection control bundle for preventing nosocomial infection by incidence of a) CDI, or BSI by b) VRE, and c) MRGN by pre-post analysis before implementation of the ABS bundle.

  2. PPI usage [ Time Frame: Baseline and every 3 months up to 144 weeks ]
    Reduction in the consumption of PPIs, measured by Defined Daily Dose (DDD) before and after IC bundle implementation

  3. Improvement of process indicators by calculating disinfectant consumption and antibiotic consumption [ Time Frame: Baseline and every 3 months up to 144 weeks ]
    Improvement of process indicators for the IC (disinfectant consumption) and ABS (antibiotic consumption) bundles by pre-post analysis before implementation of the measures

  4. Effectiveness of ABS interventions by continuously measuring RDDs [ Time Frame: Baseline and every 3 months up to 144 weeks ]
    Effectiveness of ABS interventions in reducing consumption of antibiotics discouraged for empirical treatment (3rd generation cephalosporins, glycopeptides, carbapenems, daptomycin, tigecycline, and linezolid), measured by Recommended Daily Dose (RDDs) before and after ABS bundle implementation

  5. Antibiotic consumption [ Time Frame: Baseline and every 3 months up to 144 weeks ]
    Time series analysis using monthly aggregations of antibiotic consumption (RDDs) and incidence of a) CDI, b) VRE, and c) MRGN on participating wards and correlation with IC and ABS intervention activities

  6. Cost-effectiveness by comparing expenditures of implementing IC/ABS measures with reduction in antibiotic consumption [ Time Frame: Baseline and after 144 weeks (end of the study) ]
    Cost-effectiveness of the different bundles by reducing antibiotic consumption, abbreviating average inpatient stays, and reducing the need for intensive care treatment compared to expenditure for IC and ABS bundle implementation



Information from the National Library of Medicine

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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:   Non-Probability Sample
Study Population
Patients admitted on wards with high incidence of CDI.
Criteria

Inclusion Criteria:

- patients admitted to departments with high incidence of CDI, i.e. a) hematology/oncology, b) other departments/wards demonstrating above-average infection rates (identified by previous studies)

Exclusion Criteria:

- patients admitted in opthalmology, paediatrics, psychiatry


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): NCT03250104


Contacts
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Contact: Jörg Janne Vehreschild, MD joerg-janne.vehreschild@uk-koeln.de
Contact: Annika Löhnert, MD annika.loehnert@uk-koeln.de

Locations
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Germany
University Hospital of Cologne Recruiting
Cologne, NRW, Germany, 50931
Contact: Jörg Janne Vehreschild, MD       janne.vehreschild@uk-koeln.de   
Sponsors and Collaborators
University Hospital of Cologne
Charite University, Berlin, Germany
University Hospital Freiburg
University of Hamburg
University Hospital Lübeck
University Hospital Tuebingen
Investigators
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Principal Investigator: Jörg Janne Vehreschild, MD University Hospital Cologne

Publications:

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Responsible Party: Dr. med. Jörg Janne Vehreschild, Professor, University Hospital of Cologne
ClinicalTrials.gov Identifier: NCT03250104     History of Changes
Other Study ID Numbers: TTU HAARBI 8.810
First Posted: August 15, 2017    Key Record Dates
Last Update Posted: October 16, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Individual participant data will not be shared after the end of the study

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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 Dr. med. Jörg Janne Vehreschild, University Hospital of Cologne:
antimicrobial stewardship
infection control
nosocomial infection
clostridium difficile
MRGN bacteria
health-care associated pathogens
VRE

Additional relevant MeSH terms:
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Infection
Communicable Diseases
Clostridium Infections
Cross Infection
Gram-Positive Bacterial Infections
Bacterial Infections
Iatrogenic Disease
Disease Attributes
Pathologic Processes
Anti-Bacterial Agents
Vancomycin
Antibiotics, Antitubercular
Anti-Infective Agents
Antitubercular Agents