Vancomycin (Glycopeptide) Resistant Enterococcus (VRE)CONTROLNCT02623413
Cohort Study of German Hematological / Oncological Wards to Assess the Effect of Contact Precautions on Nosocomial Colonization With Vancomycin Resistant Enterococci
An observational study of Vancomycin (Glycopeptide) Resistant Enterococcus (VRE) and Cancer, run by University of Cologne.
Trial summary
The study aims to evaluate the impact of contact precautions on the rate of VRE- the rate of colonization and infection aand hospital-acquired VRE transmissions. Hematological and oncological wards in hospitals with a non-outbreak setting for VRE and adhering to at least the following standard of care are eligible for… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Vancomycin (Glycopeptide) Resistant Enterococcus (VRE), Cancer
- How many people
- 950 participants
- Where
- No sites listed yet
- Study dates
- Jan 2016to Mar 2017
- 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: Patients treated on one of the participating wards
Who may be able to join
- Inpatient hospitalization during the study period on one of the participating wards.
Who cannot join
- None
About this study
The study aims to evaluate the impact of contact precautions on the rate of VRE- the rate of colonization and infection aand hospital-acquired VRE transmissions.
Hematological and oncological wards in hospitals with a non-outbreak setting for VRE and adhering to at least the following standard of care are eligible for study participation:
Read more
Fecal screening for the presence of VRE 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 VRE 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.
This observational study prospectively compares wards with different approaches to isolation. All screening and isolation measures are already in place on participating wards (i.e. constituted a site selection criterion) and are exclusively implemented as part of the standard of care. Sites are free to adjust their standard of care as they see fit. No intervention will be performed.
- Medical subject headings
- Neoplasms
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 |
|---|---|---|
| Sites implementing contact precautions | Centers isolating for VRE may only participate if complying with the following standards: * Contact precautions triggered by the initial detection of VRE * Patients discharged as a VRE-carrier must be placed in contact isolation upon readmission * Termination of contact precautions after at least two consecutive VRE-negative consecutive fecal screening cultures * Resumption of contact isolation on first subsequent VRE-positive culture Contact precautions must encompass the following measures: * Patients: Placement in single rooms. Cohorting is only permitted, in case of unavailability of single rooms * Staff and visitors: Wearing of gloves and gowns when entering the room. * Patients: Wearing of gloves and gowns when leaving the room. | |
| Sites not implementing contact precautions | Only VRE colonized or infected patients with urinary or fecal incontinence or diarrhea (defined as > 3 loose bowel movements/day), must be isolated in single rooms at any time during the study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of hospital-acquired VRE-colonization and/or infection
Measured: 1 year
Secondary outcomes (6)
Incidence of patient-to-patient transmission of VRE
Defined by the isolation of molecularly related VRE strains from patients with overlapping hospitalization periods in the same ward.
Measured: 1 year
Incidence of VRE intestinal colonization among all patients
Colonization is defined as the isolation of VRE from fecal screening samples
Measured: 1 year
Incidence of VRE bloodstream infections among all patients
VRE bloodstream infection is defined by the isolation of VRE from at least one blood culture
Measured: 1 year
Incidence of VRE bloodstream infections among previously colonized patients
Measured: 1 year
Readmission fraction associated with VRE infection
Measured: 1 year
Prevalence of VRE in the community.
Defined as VRE-colonization upon the first admission of a patient not transferred from another hospital or a long term care facility
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2015 (estimated)
- Study startJan 2016
- Primary completionJan 2017 (estimated)
- Study completionMar 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vancomycin (Glycopeptide) Resistant Enterococcus (VRE)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
- 950 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Cologne
- Sponsor type
- University, hospital or other
- Collaborators
- German Center for Infection Research, University Hospital Tuebingen, Universitätsklinikum Hamburg-Eppendorf, University Hospital Freiburg, Universitätsklinikum Köln
- Responsible party
- Principal investigator, Maria J.G.T. Vehreschild, University of Cologne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02623413
- Sponsor's protocol ID
- CONTROL
- Acronym
- CONTROL
- Status last verified
- Dec 2015
- First submitted
- 23 Nov 2015
- Last updated
- 7 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cohort Study of German Hematological / Oncological Wards to Assess the Effect of Contact Precautions on Nosocomial Colonization With Vancomycin Resistant Enterococci
- ClinicalTrials.gov ID
- NCT02623413
- Acronym / sponsor ID
- CONTROL / CONTROL
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 950 participants (estimated)
- Lead sponsor
- University of CologneUniversity, hospital or other
- Collaborators
- German Center for Infection Research, University Hospital Tuebingen, Universitätsklinikum Hamburg-Eppendorf, University Hospital Freiburg, Universitätsklinikum Köln
- Study start
- Jan 2016
- Primary completion
- Jan 2017 (estimated)
- Study completion
- Mar 2017 (estimated)
- First posted
- 7 Dec 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.
The study aims to evaluate the impact of contact precautions on the rate of VRE- the rate of colonization and infection aand hospital-acquired VRE transmissions.
Hematological and oncological wards in hospitals with a non-outbreak setting for VRE and adhering to at least the following standard of care are eligible for study participation:
Fecal screening for the presence of VRE 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 VRE 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.
This observational study prospectively compares wards with different approaches to isolation. All screening and isolation measures are already in place on participating wards (i.e. constituted a site selection criterion) and are exclusively implemented as part of the standard of care. Sites are free to adjust their standard of care as they see fit. No intervention will be performed.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sites implementing contact precautions | – | –Centers isolating for VRE may only participate if complying with the following standards: * Contact precautions triggered by the initial detection of VRE * Patients discharged as a VRE-carrier must be placed in contact isolation upon readmission * Termination of contact precautions after at least two consecutive VRE-negative consecutive fecal screening cultures * Resumption of contact isolation on first subsequent VRE-positive culture Contact precautions must encompass the following measures: * Patients: Placement in single rooms. Cohorting is only permitted, in case of unavailability of single rooms * Staff and visitors: Wearing of gloves and gowns when entering the room. * Patients: Wearing of gloves and gowns when leaving the room. |
| Sites not implementing contact precautions | – | –Only VRE colonized or infected patients with urinary or fecal incontinence or diarrhea (defined as > 3 loose bowel movements/day), must be isolated in single rooms at any time during the study. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients treated on one of the participating wards
Key inclusion criteria (1 listed)
Key exclusion criteria (1 listed)
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 VRE-colonization and/or infection
Time frame: 1 year
6 secondary outcomes
Incidence of patient-to-patient transmission of VRE
Time frame: 1 year
Incidence of VRE intestinal colonization among all patients
Time frame: 1 year
Incidence of VRE bloodstream infections among all patients
Time frame: 1 year
Incidence of VRE bloodstream infections among previously colonized patients
Time frame: 1 year
Readmission fraction associated with VRE infection
Time frame: 1 year
Prevalence of VRE in the community.
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2015.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Vancomycin (Glycopeptide) Resistant Enterococcus (VRE) and Cancer, 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 1 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 7 Dec 2015. 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 VRE-colonization and/or infection (time frame: 1 year). 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 7 Dec 2015.