Oncology [See Also, Affected System]CONTAINNCT02456818
Assessing the Effect of Contact Isolation on Nosocomial Colonization With ESBL-EC in German Hematology/Oncology Wards
An observational study of Oncology [See Also, Affected System] and Hematological Disease, run by University of Cologne.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Oncology [See Also, Affected System], Hematological Disease, Infection Due to ESBL Escherichia Coli
- How many people
- 2,264 participants
- Where
- No sites listed yet
- Study dates
- Jan 2015to Jun 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All admitted patients on participating hematological and oncological wards in hospitals with a non-outbreak setting for ESBL-EC.
Who may be able to join
- 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
Who cannot join
- none
About this study
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)
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.
Read the 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.
- 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
- Medical subject headings
- Hematologic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Incidence of hospital-acquired ESBL-EC colonization or infection
Measured: 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
Measured: 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)
Measured: 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)
Measured: up to 12 month
Incidence of ESBL-EC bloodstream infections among previously colonized patients - Readmission fraction associated with infection with ESBL-EC
Measured: 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.
Measured: 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.
Measured: 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.
Measured: up to 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2015 (estimated)
- Study startJan 2015
- Primary completionJun 2016 (estimated)
- Study completionJun 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oncology [See Also, Affected System]Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,264 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Cologne
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital Tuebingen, Universitätsklinikum Hamburg-Eppendorf, University Hospital, Aachen
- Responsible party
- Principal investigator, Maria J.G.T. Vehreschild, University of Cologne
- Investigators
- Maria JG Vehreschild, PD Dr., Principal investigator, university clinic of cologneOliver A Cornely, Prof Dr., Principal investigator, university clinic of cologneJörg J Vehreschild, PD Dr., Principal investigator, university clinic of cologneHarald Seifert, Prof. Dr., Principal investigator, university clinic of cologne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02456818
- Sponsor's protocol ID
- CONTAIN
- Acronym
- CONTAIN
- Status last verified
- Feb 2016
- First submitted
- 24 Feb 2015
- Last updated
- 8 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT02456818
- Acronym / sponsor ID
- CONTAIN / CONTAIN
- 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
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,264 participants (estimated)
- Lead sponsor
- University of CologneUniversity, hospital or other
- Collaborators
- University Hospital Tuebingen, Universitätsklinikum Hamburg-Eppendorf, University Hospital, Aachen
- Study start
- Jan 2015
- Primary completion
- Jun 2016 (estimated)
- Study completion
- Jun 2016 (estimated)
- First posted
- 29 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All admitted patients on participating hematological and oncological wards in hospitals with a non-outbreak setting for ESBL-EC.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- none
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Incidence of hospital-acquired ESBL-EC colonization or infection
Time frame: up to 12 month
7 secondary outcomes
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
Time frame: 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)
Time frame: 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)
Time frame: up to 12 month
Incidence of ESBL-EC bloodstream infections among previously colonized patients - Readmission fraction associated with infection with ESBL-EC
Time frame: 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)
Time frame: 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)
Time frame: up to 12 month
Incidence of ESBL-KP bloodstream infections among previously colonized patients
Time frame: up to 12 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2016.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maria JG Vehreschild, PD Dr. principal investigator
university clinic of cologne
Oliver A Cornely, Prof Dr. principal investigator
university clinic of cologne
Jörg J Vehreschild, PD Dr. principal investigator
university clinic of cologne
Questions about this trial
What is this clinical trial studying?
An observational study of Oncology [See Also, Affected System] and Hematological Disease, run by University of Cologne.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of hospital-acquired ESBL-EC colonization or infection (time frame: up to 12 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2016.