Cohort Study of German Hematological / Oncological Wards to Assess the Effect of Contact Precautions on Nosocomial Colonization With Vancomycin Resistant Enterococci

• Conditions: Vancomycin (Glycopeptide) Resistant Enterococcus (VRE); Cancer

• Registration Number: NCT02623413
• Lead Sponsor: University of Cologne

Brief Summary

The study aims to evaluate the impact of contact precautions on the rate of VRE- the rate of colonization and infection aand hospital-acquired VRE transmissions.

Hematological and oncological wards in hospitals with a non-outbreak setting for VRE and adhering to at least the following standard of care are eligible for study participation:

Fecal screening for the presence of VRE of all patients within 72 hours of each admission by use of a rectal swab or stool sample Follow-up fecal screening once a week and within 72 hours of discharge Implementation of clinical standards aimed at VRE decolonization is not allowed on wards participating in this study, including in the context of clinical studies.

Sites will be grouped according to their approach regarding contact isolation (see group description).

As a control for external factors a hand hygiene program, including training and adherence assessments, will be implemented.

This observational study prospectively compares wards with different approaches to isolation. All screening and isolation measures are already in place on participating wards (i.e. constituted a site selection criterion) and are exclusively implemented as part of the standard of care. Sites are free to adjust their standard of care as they see fit. No intervention will be performed.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-11-23
• Status Verified: 2015-12
• Study First Submitted QC: 2015-12-04
• Last Update Submitted: 2015-12-04
• Study First Posted: 2015-12-07
• Last Update Posted: 2015-12-07
• Study Start: 2016-01
• Primary Completion: 2017-01
• Study Completion: 2017-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 950

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of hospital-acquired VRE-colonization and/or infection	1 year

Secondary Outcome Measures

Name	Time	Method
Incidence of patient-to-patient transmission of VRE	1 year	Defined by the isolation of molecularly related VRE strains from patients with overlapping hospitalization periods in the same ward.
Incidence of VRE intestinal colonization among all patients	1 year	Colonization is defined as the isolation of VRE from fecal screening samples
Incidence of VRE bloodstream infections among all patients	1 year	VRE bloodstream infection is defined by the isolation of VRE from at least one blood culture
Incidence of VRE bloodstream infections among previously colonized patients	1 year
Readmission fraction associated with VRE infection	1 year
Prevalence of VRE in the community.	1 year	Defined as VRE-colonization upon the first admission of a patient not transferred from another hospital or a long term care facility