Clinical trial NCT02623413: Cohort Study of German Hematological / Oncological Wards to Assess the Effect of Contact Precautions on Nosocomial Colonization With Vancomycin Resistant Enterococci
Official title: Cohort Study of German Hematological / Oncological Wards to Assess the Effect of Contact Precautions on Nosocomial Colonization With Vancomycin Resistant Enterococci
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Vancomycin (Glycopeptide) Resistant Enterococcus (VRE)
Cancer
Lead sponsor: University of Cologne
Sponsor class: OTHER
Collaborators: name: German Center for Infection Research
name: University Hospital Tuebingen
name: Universitätsklinikum Hamburg-Eppendorf
name: University Hospital Freiburg
name: Universitätsklinikum Köln
First posted: 2015-12-07
Enrollment: 950
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients treated on one of the participating wards

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.


Eligibility criteria: * Inclusion criteria:

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

  * None

Primary outcomes:
measure: Incidence of hospital-acquired VRE-colonization and/or infection
timeFrame: 1 year
Secondary outcomes:
measure: Incidence of patient-to-patient transmission of VRE
timeFrame: 1 year
measure: Incidence of VRE intestinal colonization among all patients
timeFrame: 1 year
measure: Incidence of VRE bloodstream infections among all patients
timeFrame: 1 year
measure: Incidence of VRE bloodstream infections among previously colonized patients
timeFrame: 1 year
measure: Readmission fraction associated with VRE infection
timeFrame: 1 year
measure: Prevalence of VRE in the community.
timeFrame: 1 year
Other outcomes:
Locations:
Study officials:
References: