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

Hematological Disease Clinical Trial

— CONTAIN  

Official title:

A Hospital-based Cohort Study in German Hematological / Oncological Wards to Assess the Effect of Contact Isolation on Nosocomial Colonization With ESBL-producing Escherichia Coli (CONTAIN Study)

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT02456818
• Other study ID #: CONTAIN
• Status: Enrolling by invitation
• Phase: N/A
• First received: February 24, 2015
• Last updated: February 5, 2016
• Start date: January 2015
• Est. completion date: June 2016

Study information

• Verified date: February 2016
• Source: University of Cologne
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 2264
• Est. completion date: June 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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:

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Hematologic Diseases
• Hematological Disease
• Infection Due to ESBL Escherichia Coli
• Neoplasms
• Oncology [See Also, Affected System]

Locations

Country	Name	City	State
n/a

Sponsors (4)

Lead Sponsor	Collaborator
University of Cologne	Universitätsklinikum Hamburg-Eppendorf, University Hospital Tuebingen, University Hospital, Aachen

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of hospital-acquired ESBL-EC colonization or infection		up to 12 month	No
Secondary	Incidence of patient-to-patient transmission of ESBL-EC defined by the isolation of two or more ESBL-EC strains from two or more different patients with overlapping hospitalization periods in the same ward, related to each other on the basis of molecular		up to 12 month	No
Secondary	Incidence of ESBL-EC intestinal colonization among all patients (colonization is defined as the isolation of ESBL-EC in material from fecal screening)		up to 12 month	No
Secondary	Incidence of ESBL-EC bloodstream infections among all patients (ESBL-EC bloodstream infection is defined by the isolation of ESBL-EC from blood cultures)		up to 12 month	No
Secondary	Incidence of ESBL-EC bloodstream infections among previously colonized patients - Readmission fraction associated with infection with ESBL-EC		up to 12 month	No
Secondary	Incidence of ESBL-Klebsiella pneumonia (ESBL-KP) colonized patients among all patients (colonization is defined as the isolation of ESBL-KP in material from fecal screening)	In theory, the ability to produce ESBL can be transferred between species by plasmids. However, in clinical practice, this seems to be an extremely rare event. Nevertheless, it should be assessed to detect any potential risks to patients at sites not isolating for ESBL-EC.	up to 12 month	Yes
Secondary	Incidence of ESBL-KP bloodstream infections among all patients (ESBL-EC bloodstream infection is defined by the isolation of ESBL-KP from blood cultures)	In theory, the ability to produce ESBL can be transferred between species by plasmids. However, in clinical practice, this seems to be an extremely rare event. Nevertheless, it should be assessed to detect any potential risks to patients at sites not isolating for ESBL-EC.	up to 12 month	Yes
Secondary	Incidence of ESBL-KP bloodstream infections among previously colonized patients	In theory, the ability to produce ESBL can be transferred between species by plasmids. However, in clinical practice, this seems to be an extremely rare event. Nevertheless, it should be assessed to detect any potential risks to patients at sites not isolating for ESBL-EC.	up to 12 month	Yes