Transplantation InfectionNCT02463214
Prevention of Healthcare Associated Infections in Bone Marrow Transplant Patients
A study testing Engineered Room in people with Transplantation Infection, run by University of British Columbia at 1 site in Canada.
Trial summary
This study involves sampling bone marrow transplant patients, hospital workers and the patient room for microbes using swabs and other techniques. We send these samples to the laboratory, where they will use state-of-the art technology to identify and relate the microbes to each other. Read more about this study
- Who is it for?
- Ages 19 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Transplantation Infection
- What is being tested?
- Engineered Room
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteCanada
- Study dates
- Sep 2015to Mar 2018
- Phase
- Interventional
- 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 19 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- undergoing allogenic bone marrow transplant for acute myeloid leukemia
- will be admitted to the leukemia and bone marrow transplant service at Vancouver General Hospital
- admission to the ward anticipated to be approximately 28 days
- undergoing allogenic bone marrow transplant for acute myeloid leukemia
- caring for patient enrolled in the study as a primary nurse
Who cannot join
- allergies to copper, nickel or titanium
- patients admitted for stays anticipated to be less than 28 days
- allergies to copper, nickel or titanium
Trial locations and contacts
1 site in 1 country.
About this study
This study involves sampling bone marrow transplant patients, hospital workers and the patient room for microbes using swabs and other techniques. We send these samples to the laboratory, where they will use state-of-the art technology to identify and relate the microbes to each other. This study also involves putting copper, nickel, or titanium into some hospital rooms, and seeing whether these metals influences the growth of microbes. Some equipment in the hospital room, such as faucets and soap dispensers will be replaced by sensor-based (e.g. touchless) controls.
Read the detailed description
Bacteria and other microbes are everywhere, the majority of which are harmless. They live on our bodies, on everyday objects, in food, and in our environment. They are passed around through the many interactions with other people and our surroundings. Some are even beneficial, helping us digest our food or protecting us from infections caused by harmful microbes.
In rare instances, some of the harmful microbes can cause infections. When a microbe causes an infection while we are in healthcare facilities, they are called "Healthcare-associated infections", or "HAIs". Examples that you may have heard of include Clostridium difficile, and MRSA (methicillin-resistant Staphylococcus aureus). Vancouver General Hospital already has some of the lowest HAI rates in the country. We have dedicated hospital workers that do a great job at preventing HAIs, but we are always looking for ways to be even better.
- Conditions
- Transplantation Infection
- Being tested
- Engineered Room
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Engineered RoomOther
Touchless devices:
Hand sanitizers, faucets, paper towel dispensers, call devices, Ultraviolet C Aseptix™ Disinfection devices above bathroom doors
Copper products:
Room and bathroom entrance door hardware, over bed table and bed side table surfaces, chair metal arms, wardrobe handles and knobs, weigh scale, sinks, grab bars, light switch panels, toilet flush handles, faucets and handles, patient bed rails.
Titanium dioxide paint:
Room walls, head walls, light switches, bathroom wall shelves, toilet tank and bowl, head wall unit fixed equipment, television remote and Bed Control remote
| Study group | Role | What they receive |
|---|---|---|
| Standard Room | No intervention | Standard bone marrow transplant recovery, single occupancy, room |
| Engineered Room | Experimental | Single occupancy bone marrow transplant recovery room, engineered with touchless devices, and surfaces coated with either copper or titanium dioxide. Receives: Other: Engineered Room |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in bioburden on surfaces
Looking to see the effectiveness of copper and titanium on the microbiota in the environment of the recovery room.
Measured: up to 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2015 (estimated)
- Study startSep 2015
- Primary completionMar 2018
- Study completionMar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Transplantation InfectionStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Collaborators
- Vancouver Coastal Health Research Institute
- Responsible party
- Principal investigator, Linda Hoang, University of British Columbia
- Investigators
- Linda Hoang, MD FRCPC, Principal investigator, The University of British ColumbiaElizabeth Bryce, MD FRCPC, Principal investigator, The University of British ColumbiaPatrick Tang, MD PhD FRCPC, Principal investigator, Sidra Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02463214
- Sponsor's protocol ID
- H15-00662
- Status last verified
- Apr 2019
- First submitted
- 2 Jun 2015
- Last updated
- 17 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of Healthcare Associated Infections in Bone Marrow Transplant Patients
- ClinicalTrials.gov ID
- NCT02463214
- Acronym / sponsor ID
- H15-00662
- Conditions
- Transplantation Infection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Collaborators
- Vancouver Coastal Health Research Institute
- Study start
- Sep 2015
- Primary completion
- Mar 2018 (actual)
- Study completion
- Mar 2018 (actual)
- First posted
- 4 Jun 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 involves sampling bone marrow transplant patients, hospital workers and the patient room for microbes using swabs and other techniques. We send these samples to the laboratory, where they will use state-of-the art technology to identify and relate the microbes to each other. This study also involves putting copper, nickel, or titanium into some hospital rooms, and seeing whether these metals influences the growth of microbes. Some equipment in the hospital room, such as faucets and soap dispensers will be replaced by sensor-based (e.g. touchless) controls.
Detailed description
Bacteria and other microbes are everywhere, the majority of which are harmless. They live on our bodies, on everyday objects, in food, and in our environment. They are passed around through the many interactions with other people and our surroundings. Some are even beneficial, helping us digest our food or protecting us from infections caused by harmful microbes.
In rare instances, some of the harmful microbes can cause infections. When a microbe causes an infection while we are in healthcare facilities, they are called "Healthcare-associated infections", or "HAIs". Examples that you may have heard of include Clostridium difficile, and MRSA (methicillin-resistant Staphylococcus aureus). Vancouver General Hospital already has some of the lowest HAI rates in the country. We have dedicated hospital workers that do a great job at preventing HAIs, but we are always looking for ways to be even better.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Room | No intervention | –Standard bone marrow transplant recovery, single occupancy, room |
| Engineered Room | Experimental | Other: Engineered RoomSingle occupancy bone marrow transplant recovery room, engineered with touchless devices, and surfaces coated with either copper or titanium dioxide. |
Who may qualify
- Ages
- 19 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- undergoing allogenic bone marrow transplant for acute myeloid leukemia
- will be admitted to the leukemia and bone marrow transplant service at Vancouver General Hospital
- admission to the ward anticipated to be approximately 28 days
- undergoing allogenic bone marrow transplant for acute myeloid leukemia
- caring for patient enrolled in the study as a primary nurse
Key exclusion criteria (3 listed)
- allergies to copper, nickel or titanium
- patients admitted for stays anticipated to be less than 28 days
- allergies to copper, nickel or titanium
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Engineered RoomTouchless devices: Hand sanitizers, faucets, paper towel dispensers, call devices, Ultraviolet C Aseptix™ Disinfection devices above bathroom doors Copper products: Room and bathroom entrance door hardware, over bed table and bed side table surfaces, chair metal arms, wardrobe handles and knobs, weigh scale, sinks, grab bars, light switch panels, toilet flush handles, faucets and handles, patient bed rails. Titanium dioxide paint: Room walls, head walls, light switches, bathroom wall shelves, toilet tank and bowl, head wall unit fixed equipment, television remote and Bed Control remote | Other | Engineered Room |
Primary outcome
Change in bioburden on surfaces
Time frame: up to 28 days
Looking to see the effectiveness of copper and titanium on the microbiota in the environment of the recovery room.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2019.
Related trials for Transplantation Infection
RecruitingObservational study
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Pilot Trial of Allogeneic Blood or Marrow Transplantation for Primary Immunodeficiencies
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Autologous Fecal Microbiota Transplantation (Auto-FMT) for Prophylaxis of Clostridium Difficile Infection in Recipients of Allogeneic Hematopoietic Stem Cell Transplantation
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TETRAVI Multivirus CTL for Treatment of EBV, CMV, Adenovirus, and BK Infections Post Allogeneic SCT.
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RecruitingPhase 1/2
Trial of Allogeneic Reduced-Intensity, HLA-Haploidentical Allogeneic Hematopoietic Cell Bone Marrow Transplantation Followed by Graft-versus-Host-Disease (GVHD) Prophylaxis With Cyclophosphamide, Bortezomib and Maraviroc for Hematologic Malignancies ...
HIV, Hematologic Malignancies
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.
Linda Hoang, MD FRCPC principal investigator
The University of British Columbia
Elizabeth Bryce, MD FRCPC principal investigator
The University of British Columbia
Patrick Tang, MD PhD FRCPC principal investigator
Sidra Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Engineered Room in people with Transplantation Infection, run by University of British Columbia at 1 site in Canada.
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 5 inclusion and 3 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: finished, as of the sponsor's last update on 17 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in bioburden on surfaces (time frame: up to 28 days). 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 17 Apr 2019.