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

Study Overview
=================
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.

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)

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

Participation Criteria
=================
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
Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Centers using contact isolation<br>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<br>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 | Measure Description | 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Colonization, Multi-resistant gram negative bacteria, Infection control measures, Hand hygiene program, Contact precautions, Immunocompromised host