Clinical trial NCT02456818: Assessing the Effect of Contact Isolation on Nosocomial Colonization With ESBL-EC in German Hematology/Oncology Wards
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)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Oncology [See Also, Affected System]
Hematological Disease
Infection Due to ESBL Escherichia Coli
Keywords: Colonization
Multi-resistant gram negative bacteria
Infection control measures
Hand hygiene program
Contact precautions
Immunocompromised host
Lead sponsor: University of Cologne
Sponsor class: OTHER
Collaborators: name: University Hospital Tuebingen
name: Universitätsklinikum Hamburg-Eppendorf
name: University Hospital, Aachen
First posted: 2015-05-29
Enrollment: 2264
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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

Primary outcomes:
measure: Incidence of hospital-acquired ESBL-EC colonization or infection
timeFrame: up to 12 month
Secondary outcomes:
measure: 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
timeFrame: up to 12 month
measure: Incidence of ESBL-EC intestinal colonization among all patients (colonization is defined as the isolation of ESBL-EC in material from fecal screening)
timeFrame: up to 12 month
measure: Incidence of ESBL-EC bloodstream infections among all patients (ESBL-EC bloodstream infection is defined by the isolation of ESBL-EC from blood cultures)
timeFrame: up to 12 month
measure: Incidence of ESBL-EC bloodstream infections among previously colonized patients - Readmission fraction associated with infection with ESBL-EC
timeFrame: up to 12 month
measure: 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)
timeFrame: up to 12 month
measure: Incidence of ESBL-KP bloodstream infections among all patients (ESBL-EC bloodstream infection is defined by the isolation of ESBL-KP from blood cultures)
timeFrame: up to 12 month
measure: Incidence of ESBL-KP bloodstream infections among previously colonized patients
timeFrame: up to 12 month
Other outcomes:
Locations:
Study officials:
affiliation: university clinic of cologne
name: Maria JG Vehreschild, PD Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: university clinic of cologne
name: Oliver A Cornely, Prof Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: university clinic of cologne
name: Jörg J Vehreschild, PD Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: university clinic of cologne
name: Harald Seifert, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References: