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

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.

Study Overview

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

• Study Type: Observational
• Enrollment (Anticipated): 950

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients treated on one of the participating wards

Description

• Inclusion criteria:

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

• Exclusion criteria:

  • None

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Incidence of hospital-acquired VRE-colonization and/or infection	1 year

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Cologne
• Collaborators: University Hospital Tuebingen; University Hospital Freiburg; Universitätsklinikum Hamburg-Eppendorf; German Center for Infection Research; Universitätsklinikum Köln

Study record dates

Study Major Dates

• Study Start: January 1, 2016
• Primary Completion (Anticipated): January 1, 2017
• Study Completion (Anticipated): March 1, 2017

Study Registration Dates

• First Submitted: November 23, 2015
• First Submitted That Met QC Criteria: December 4, 2015
• First Posted (Estimate): December 7, 2015

Study Record Updates

• Last Update Posted (Estimate): December 7, 2015
• Last Update Submitted That Met QC Criteria: December 4, 2015
• Last Verified: December 1, 2015

More Information

Terms related to this study

• Other Study ID Numbers: CONTROL