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

Cancer Clinical Trial

— CONTROL  

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT02623413
• Other study ID #: CONTROL
• Status: Enrolling by invitation
• Phase: N/A
• First received: November 23, 2015
• Last updated: December 4, 2015
• Start date: January 2016
• Est. completion date: March 2017

Study information

• Verified date: December 2015
• Source: University of Cologne
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany:Geschäftsstelle Ethikkommission Universität zu Köln
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 950
• Est. completion date: March 2017
• Est. primary completion date: January 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

• Inclusion criteria:

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

• Exclusion criteria:

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Cancer
• Vancomycin (Glycopeptide) Resistant Enterococcus (VRE)

Locations

Country	Name	City	State
n/a

Sponsors (6)

Lead Sponsor	Collaborator
University of Cologne	German Center for Infection Research, Universitätsklinikum Hamburg-Eppendorf, Universitätsklinikum Köln, University Hospital Freiburg, University Hospital Tuebingen

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of hospital-acquired VRE-colonization and/or infection		1 year	No
Secondary	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	No
Secondary	Incidence of VRE intestinal colonization among all patients	Colonization is defined as the isolation of VRE from fecal screening samples	1 year	No
Secondary	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	No
Secondary	Incidence of VRE bloodstream infections among previously colonized patients		1 year	No
Secondary	Readmission fraction associated with VRE infection		1 year	No
Secondary	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	No