Skip to content

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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02623413
Acronym
CONTROL
Enrollment
950
Registered
2015-12-07
Start date
2016-01-31
Completion date
2017-03-31
Last updated
2015-12-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer, Vancomycin (Glycopeptide) Resistant Enterococcus (VRE)

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.

Interventions

None listed

Sponsors

German Center for Infection Research
CollaboratorOTHER
University Hospital Tuebingen
CollaboratorOTHER
Universitätsklinikum Hamburg-Eppendorf
CollaboratorOTHER
University Hospital Freiburg
CollaboratorOTHER
Universitätsklinikum Köln
CollaboratorOTHER
University of Cologne
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

* None

Design outcomes

Primary

MeasureTime frame
Incidence of hospital-acquired VRE-colonization and/or infection1 year

Secondary

MeasureTime frameDescription
Incidence of VRE intestinal colonization among all patients1 yearColonization is defined as the isolation of VRE from fecal screening samples
Incidence of VRE bloodstream infections among all patients1 yearVRE bloodstream infection is defined by the isolation of VRE from at least one blood culture
Incidence of patient-to-patient transmission of VRE1 yearDefined by the isolation of molecularly related VRE strains from patients with overlapping hospitalization periods in the same ward.
Readmission fraction associated with VRE infection1 year
Prevalence of VRE in the community.1 yearDefined as VRE-colonization upon the first admission of a patient not transferred from another hospital or a long term care facility
Incidence of VRE bloodstream infections among previously colonized patients1 year

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026