Ignite Creation Date:
2025-12-25 @ 4:33 AM
Ignite Modification Date:
2026-03-04 @ 10:43 PM
Study NCT ID:
NCT02456818
Status:
UNKNOWN
Last Update Posted:
2016-02-08
First Post:
2015-02-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Assessing the Effect of Contact Isolation on Nosocomial Colonization With ESBL-EC in German Hematology/Oncology Wards
Sponsor:
University of Cologne
Organization:
Study Overview
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)
Status:
UNKNOWN
Status Verified Date:
2016-02
Last Known Status:
ENROLLING_BY_INVITATION
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CONTAIN
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: