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

NCT03250104 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 80000

Last updated 2020-07-31

No results posted yet for this study

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.

Conditions

  • Clostridium Difficile Infection
  • VRE Infection
  • Nosocomial Infection
  • MRGN Bacteria

Interventions

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.

Sponsors & Collaborators

  • Charite University, Berlin, Germany

    collaborator OTHER
  • University Hospital Freiburg

    collaborator OTHER
  • University of Hamburg-Eppendorf

    collaborator OTHER
  • University Hospital Lübeck

    collaborator OTHER
  • University Hospital Tuebingen

    collaborator OTHER
  • University Hospital of Cologne

    lead OTHER

Principal Investigators

  • Jörg Janne Vehreschild, MD · University Hospital Cologne

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-11-30
Primary Completion
2018-12-31
Completion
2019-07-31

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03250104 on ClinicalTrials.gov