Hematological Disease, Infection Due to ESBL Escherichia Coli, Oncology [See Also, Affected System]
Conditions
Keywords
Colonization, Multi-resistant gram negative bacteria, Infection control measures, Hand hygiene program, Contact precautions, Immunocompromised host
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.
Interventions
None listed
Sponsors
University Hospital Tuebingen
Universitätsklinikum Hamburg-Eppendorf
University Hospital, Aachen
University of Cologne
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of hospital-acquired ESBL-EC colonization or infection | up to 12 month |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 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-KP bloodstream infections among all patients (ESBL-EC bloodstream infection is defined by the isolation of ESBL-KP from blood cultures) | up to 12 month | 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. |
| Incidence of ESBL-KP bloodstream infections among previously colonized patients | up to 12 month | 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. |
| 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) | up to 12 month | 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. |
Outcome results
None listed