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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

950 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-01-31

Study Completion Date

2017-03-31

Brief Summary

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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

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Conditions

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Vancomycin (Glycopeptide) Resistant Enterococcus (VRE) Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Sites implementing contact precautions

Centers isolating for VRE may only participate if complying with the following standards:

* Contact precautions triggered by the initial detection of VRE
* Patients discharged as a VRE-carrier must be placed in contact isolation upon readmission
* Termination of contact precautions after at least two consecutive VRE-negative consecutive fecal screening cultures
* Resumption of contact isolation on first subsequent VRE-positive culture

Contact precautions must encompass the following measures:

* Patients: Placement in single rooms. Cohorting is only permitted, in case of unavailability of single rooms
* Staff and visitors: Wearing of gloves and gowns when entering the room.
* Patients: Wearing of gloves and gowns when leaving the room.

No interventions assigned to this group

Sites not implementing contact precautions

Only VRE colonized or infected patients with urinary or fecal incontinence or diarrhea (defined as \> 3 loose bowel movements/day), must be isolated in single rooms at any time during the study.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Inpatient hospitalization during the study period on one of the participating wards.

Exclusion Criteria

* None

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Maria J.G.T. Vehreschild

PD Dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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CONTROL

Identifier Type: -

Identifier Source: org_study_id