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

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)

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.

Study Overview

• Status: Unknown
• Conditions: Hematological Disease; Oncology [See Also, Affected System]; Infection Due to ESBL Escherichia Coli

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.

• Study Type: Observational
• Enrollment (Anticipated): 2264

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

All admitted patients on participating hematological and oncological wards in hospitals with a non-outbreak setting for ESBL-EC.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Incidence of hospital-acquired ESBL-EC colonization or infection	up to 12 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
Incidence of ESBL-EC bloodstream infections among previously colonized patients - Readmission fraction associated with infection with ESBL-EC		up to 12 month
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
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
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

Collaborators and Investigators

• Sponsor: University of Cologne
• Collaborators: University Hospital Tuebingen; Universitätsklinikum Hamburg-Eppendorf; University Hospital, Aachen
• Investigators: Principal Investigator: Maria JG Vehreschild, PD Dr., university clinic of cologne; Principal Investigator: Oliver A Cornely, Prof Dr., university clinic of cologne; Principal Investigator: Jörg J Vehreschild, PD Dr., university clinic of cologne; Principal Investigator: Harald Seifert, Prof. Dr., university clinic of cologne

Study record dates

Study Major Dates

• Study Start: January 1, 2015
• Primary Completion (Anticipated): June 1, 2016
• Study Completion (Anticipated): June 1, 2016

Study Registration Dates

• First Submitted: February 24, 2015
• First Submitted That Met QC Criteria: May 26, 2015
• First Posted (Estimate): May 29, 2015

Study Record Updates

• Last Update Posted (Estimate): February 8, 2016
• Last Update Submitted That Met QC Criteria: February 5, 2016
• Last Verified: February 1, 2016

More Information

Terms related to this study

• Keywords: Colonization; Immunocompromised host; Multi-resistant gram negative bacteria; Infection control measures; Hand hygiene program; Contact precautions
• Additional Relevant MeSH Terms: Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Enterobacteriaceae Infections; Neoplasms; Hematologic Diseases; Escherichia coli Infections
• Other Study ID Numbers: CONTAIN