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

NCT02456818 | Unknown

• 1 other identifier: CONTAIN
• Study Type: observational
• Target: 2,264
• Locations: 0 countries
• Sites: N/A

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.

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

Outcome Measures

Primary Outcomes (1)

• Incidence of hospital-acquired ESBL-EC colonization or infection

  up to 12 month

Secondary Outcomes (7)

• 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)

  up to 12 month

Study Arms (2)

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

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• none

Sponsors & Collaborators

• University of Cologne: lead
• University Hospital Tuebingen: collaborator
• Universitätsklinikum Hamburg-Eppendorf: collaborator
• University Hospital, Aachen: collaborator

Biospecimen

Retention: SAMPLES WITH DNA

Rectal swabs or stool samples

MeSH Terms

Conditions

Hematologic Diseases

Condition Hierarchy (Ancestors)

Hemic and Lymphatic Diseases

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PD Dr.med

Study Record Dates

• First Submitted: February 24, 2015
• First Posted: May 29, 2015
• Study Start: January 1, 2015
• Primary Completion: June 1, 2016
• Study Completion: June 1, 2016
• Last Updated: February 8, 2016

Record last verified: 2016-02