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

NCT02623413 | Unknown

• 1 other identifier: CONTROL
• Study Type: observational
• Target: 950
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Vancomycin (Glycopeptide) Resistant Enterococcus (VRE); Cancer

Outcome Measures

Primary Outcomes (1)

• Incidence of hospital-acquired VRE-colonization and/or infection

  1 year

Secondary Outcomes (6)

• Incidence of patient-to-patient transmission of VRE

  1 year

• Incidence of VRE intestinal colonization among all patients

  1 year

• Incidence of VRE bloodstream infections among all patients

  1 year

• Incidence of VRE bloodstream infections among previously colonized patients

  1 year

• Readmission fraction associated with VRE infection

  1 year

Study Arms (2)

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.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients treated on one of the participating wards

You may qualify if:

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

You may not qualify if:

• None

Sponsors & Collaborators

• University of Cologne: lead
• German Center for Infection Research: collaborator
• University Hospital Tuebingen: collaborator
• Universitätsklinikum Hamburg-Eppendorf: collaborator
• University Hospital Freiburg: collaborator
• Universitätsklinikum Köln: collaborator

Biospecimen

Retention: SAMPLES WITHOUT DNA

Cultured VRE strains from rectal swabs, stool samples and infection sites.

MeSH Terms

Conditions

Neoplasms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PD Dr.

Study Record Dates

• First Submitted: November 23, 2015
• First Posted: December 7, 2015
• Study Start: January 1, 2016
• Primary Completion: January 1, 2017
• Study Completion: March 1, 2017
• Last Updated: December 7, 2015

Record last verified: 2015-12