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

University of Cologne

Status: Unknown

Conditions: Vancomycin (Glycopeptide) Resistant Enterococcus (VRE); Cancer

Study type: Observational

Funder types: Other

Identifiers

NCT02623413

CONTROL

Details and patient eligibility

About

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.

Enrollment: 950 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

• Inclusion criteria:

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

• Exclusion criteria:

  • None

Trial design

950 participants in 2 patient groups

Sites implementing contact precautions

Description:

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

Description:

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.