Assessing the Effect of Contact Isolation on Nosocomial Colonization With ESBL-EC in German Hematology/Oncology Wards

NCT ID: NCT02456818

Last Updated: 2016-02-08

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 2264 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-01-31
• Study Completion Date: 2016-06-30

Brief Summary

This study aims to evaluate the impact of contact isolation on the rate of hospital-acquired transmissions of ESBL-producing Escherichia coli (ESBL-EC) and the rate of colonization and infection. On the basis of this study, it will be possible to re-evaluate the need for contact isolation for patients colonized or infected with ESBL-EC.

Detailed Description

The study aims to evaluate the impact of contact isolation on the rate of hospital-acquired transmissions of ESBL-producing Escherichia coli and the rate of colonization and infection.

Hematological and oncological wards in hospitals with a non-outbreak setting for ESBL-EC and adhering to at least the following standard of care are eligible for study participation:

• Fecal screening for the presence of ESBL-EC 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 ESBL-EC 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.

Conditions

Oncology [See Also, Affected System]; Hematological Disease; Infection Due to ESBL Escherichia Coli

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Centers using contact isolation

• Isolation triggered by the detection of ESBL-EC at hospital admission in surveillance screening or during the hospitalization by weekly screening or clinical cultures
• Contact isolation terminated, after at least two negative consecutive fecal screening cultures
• Contact isolation resumed, if subsequent ESBL-EC positive cultures are identified for the same patient including readmissions

Contact isolation must include:

• Patient placement in single rooms
• Cohorting only possible, when no single rooms available and corresponding ESBL-EC strains are phenotypically identical
• Staff and visitors wearing gloves and gowns as contact precautions when entering the room, patient when leaving the room

No interventions assigned to this group

Centers using no contact isolation

• not regularly isolating for ESBL-EC
• ESBL-EC colonized or infected patients with urinary or fecal incontinence or diarrhea (>3 loose bowel movements/day) isolated in single rooms with above described contact precautions

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• Wards adhering to at least the following standard of care are eligible for study participation:
• Fecal screening for the presence of ESBL-EC 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

Exclusion Criteria

• none

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital Tuebingen

OTHER

Sponsor Role: collaborator

Universitätsklinikum Hamburg-Eppendorf

OTHER

Sponsor Role: collaborator

University Hospital, Aachen

OTHER

Sponsor Role: collaborator

University of Cologne

OTHER

Sponsor Role: lead

Responsible Party

Maria J.G.T. Vehreschild

PD Dr.med

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Maria JG Vehreschild, PD Dr.

Role: PRINCIPAL_INVESTIGATOR

university clinic of cologne

Oliver A Cornely, Prof Dr.

Role: PRINCIPAL_INVESTIGATOR

university clinic of cologne

Jörg J Vehreschild, PD Dr.

Role: PRINCIPAL_INVESTIGATOR

university clinic of cologne

Harald Seifert, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

university clinic of cologne

Other Identifiers

CONTAIN

Identifier Type: -

Identifier Source: org_study_id