Healthcare Associated InfectionUVCLEAR-MDRONCT02605499
Ultra Violet-C Light Evaluation as an Adjunct to Removing Multi-Drug Resistant Organisms (UVCLEAR-MDRO)
A study testing UV-C light disinfection in people with Healthcare Associated Infection and Multidrug Resistant Organisms, run by Johns Hopkins University.
Trial summary
This study examines the impact of UV-C light disinfection as an adjunct to routine daily and discharge patient room cleaning on patient infection and colonization with hospital associated bacteria. Patient rooms are counted as enrolled since consent was waived and the number of participants is unknown. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Healthcare Associated Infection, Multidrug Resistant Organisms
- What is being tested?
- UV-C light disinfection
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 83 participants
- Where
- No sites listed yet
- Study dates
- Dec 2015to Feb 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patient rooms in pre-selected hospital units within Johns Hopkins Hospital
Who cannot join
- None, intervention is at level of the hospital unit, not the patient
About this study
This study examines the impact of UV-C light disinfection as an adjunct to routine daily and discharge patient room cleaning on patient infection and colonization with hospital associated bacteria.
Patient rooms are counted as enrolled since consent was waived and the number of participants is unknown. Total of 83 rooms.
Read the detailed description
Effective cleaning of the patient environment (the patient room during hospital stay) is subject to human factors and unfortunately is often inconsistent or inadequate. Patient rooms that have residual bacteria after routine environmental cleaning can act as reservoirs for multidrug-resistant organisms (MDROs) and contribute to the spread of MDROs from patient to patient. In the setting of an increased focus on Healthcare-associated Infections such as Clostridium difficile (C. difficile) and multidrug-resistant Gram negative and Gram positive organisms such as carbapenem-resistant Enterobacteriaceae (CRE), vancomycin-resistant Enterococcus (VRE) and methicillin-resistant Staphlococcus aureus (MRSA), Ultra-Violet C (UV-C) light has been shown to be a safe, effective way to decrease the burden of MDROs in patient rooms. However, studies examining the effectiveness of UV-C light when used post daily and discharge patient room cleaning are lacking.
This study is a cluster, randomized, two-period cross over trial to investigate the relationship between environmental decontamination with UV-C light and transmission of VRE and other healthcare-associated bacteria. It investigates the hypothesis that UV-C in addition to daily cleaning leads to decreased patient acquisition of healthcare-associated bacteria.
This study is important to further advance hospital-based infection prevention knowledge of the impact of UV-C light for environmental cleaning.
Patient rooms are counted as enrolled since consent was waived and the number of participants is unknown. Total of 83 rooms.
- Being tested
- UV-C light disinfection
- Medical subject headings
- Cross Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UV-C light disinfectionOther
UV-C light disinfection will be used in hospital patient rooms as an adjunct to routine daily and discharge cleaning.
| Study group | Role | What they receive |
|---|---|---|
| UV-C light disinfection | Experimental | During intervention UV-C light disinfection will be used in hospital patient rooms as an adjunct to routine daily and discharge cleaning. Receives: Other: UV-C light disinfection |
| Control | No intervention | During control period there will be standard discharge and daily room cleaning only, with no UV-C light disinfection. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acquisition of Vancomycin Resistant Enterococcus
Rates of Vancomycin Resistant Enterococcus acquisition will be compared between intervention and control periods.
Measured: 2 years
Acquisition of a composite rate of healthcare-associated bacteria: Vancomycin Resistant Enterococcus, Methicillin Resistant Staphylococcus Aureus, hospital-onset bacteremias, Clostridium difficile, and central line associated bloodstream infections.
Rates of Vancomycin Resistant Enterococcus, Methicillin Resistant Staphylococcus Aureus, hospital-onset bacteremias, multidrug resistant gram negative bacteria, Clostridium difficile, and central line associated bloodstream infections will be compared between intervention and control periods.
Measured: 2 years
Secondary outcomes (13)
Acquisition of Vancomycin Resistant Enterococcus (clinical infection)
Rates of Vancomycin Resistant Enterococcus acquisition (clinical infection) will be compared between intervention and control periods.
Measured: 2 years
Acquisition of Vancomycin Resistant Enterococcus (colonization)
Rates of Vancomycin Resistant Enterococcus acquisition (colonization) will be compared between intervention and control periods.
Measured: 2 years
Acquisition of Clostridium difficile (infection)
Rates of Clostridium difficile infection will be compared between intervention and control periods.
Measured: 2 years
Acquisition of Clostridium difficile (colonization or infection)
Rates of Clostridium difficile (colonization or infection) will be compared between the intervention and control arms.
Measured: 2 years
Acquisition of bacteremia
Rates of hospital onset bacteremia will be compared between the intervention and control arms.
Measured: 2 years
Acquisition of Methicillin Resistant Staphylococcus Aureus (clinical)
Rates of Methicillin Resistant Staphylococcus Aureus acquisition (clinical infection) will be compared between intervention and control periods.
Measured: 2 years
Acquisition of Methicillin Resistant Staphylococcus Aureus (colonization)
Rates of Methicillin Resistant Staphylococcus Aureus acquisition (colonization) will be compared between intervention and control periods.
Measured: 2 years
Acquisition of Methicillin Resistant Staphylococcus Aureus (clinical or colonization)
Rates of Methicillin Resistant Staphylococcus Aureus acquisition (clinical or colonization) will be compared between intervention and control periods.
Measured: 2 years
Acquisition of Central line associated bloodstream infections
Rates of Central line associated bloodstream infections in intervention and control arms will be compared.
Measured: 2 years
Acquisition of multidrug resistant gram negative bacteria (colonization)
Rates of multidrug resistant gram negative bacteria acquisition (colonization) will be compared between intervention and control periods.
Measured: 2 years
Acquisition of multidrug resistant gram negative bacteria
Rates of multidrug resistant gram negative bacteria acquisition will be compared between intervention and control periods.
Measured: 2 years
Differences in patient overall satisfaction with hospital stay as assessed by the Hospital Consumer Assessment of Healthcare Providers and Systems Survey.
Patient satisfaction with overall hospital stay will be compared between intervention and control arms.
Measured: 2 years
Differences in patient satisfaction with environmental cleaning as assessed by the Hospital Consumer Assessment of Healthcare Providers and Systems Survey.
Patient satisfaction with environmental cleaning will be compared between intervention and control arms.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2015 (estimated)
- Study startDec 2015
- Primary completionFeb 2018
- Study completionFeb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Healthcare Associated InfectionStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe 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
- Crossover
- Model description
- Patient rooms are counted as enrolled since consent was waived and the number of participants is unknown. Total of 83 rooms.
- Masking
- None (open label)
- Enrolment
- 83 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lisa Maragakis, MD, MPH, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02605499
- Sponsor's protocol ID
- IRB00063160
- Acronym
- UVCLEAR-MDRO
- Status last verified
- Sep 2018
- First submitted
- 11 Nov 2015
- Last updated
- 19 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Rock C, Hsu YJ, Curless MS, Carroll KC, Ross Howard T, Carson KA, Cummings S, Anderson M, Milstone AM, Maragakis LL. Ultraviolet-C Light Evaluation as Adjunct Disinfection to Remove Multidrug-Resistant Organisms. Clin Infect Dis. 2022 Aug 24;75(1):35-40. doi: 10.1093/cid/ciab896.
PubMed 34636853
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultra Violet-C Light Evaluation as an Adjunct to Removing Multi-Drug Resistant Organisms (UVCLEAR-MDRO)
- ClinicalTrials.gov ID
- NCT02605499
- Acronym / sponsor ID
- UVCLEAR-MDRO / IRB00063160
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 83 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Study start
- Dec 2015 (actual)
- Primary completion
- Feb 2018 (actual)
- Study completion
- Feb 2018 (actual)
- First posted
- 16 Nov 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 examines the impact of UV-C light disinfection as an adjunct to routine daily and discharge patient room cleaning on patient infection and colonization with hospital associated bacteria.
Patient rooms are counted as enrolled since consent was waived and the number of participants is unknown. Total of 83 rooms.
Detailed description
Effective cleaning of the patient environment (the patient room during hospital stay) is subject to human factors and unfortunately is often inconsistent or inadequate. Patient rooms that have residual bacteria after routine environmental cleaning can act as reservoirs for multidrug-resistant organisms (MDROs) and contribute to the spread of MDROs from patient to patient. In the setting of an increased focus on Healthcare-associated Infections such as Clostridium difficile (C. difficile) and multidrug-resistant Gram negative and Gram positive organisms such as carbapenem-resistant Enterobacteriaceae (CRE), vancomycin-resistant Enterococcus (VRE) and methicillin-resistant Staphlococcus aureus (MRSA), Ultra-Violet C (UV-C) light has been shown to be a safe, effective way to decrease the burden of MDROs in patient rooms. However, studies examining the effectiveness of UV-C light when used post daily and discharge patient room cleaning are lacking.
This study is a cluster, randomized, two-period cross over trial to investigate the relationship between environmental decontamination with UV-C light and transmission of VRE and other healthcare-associated bacteria. It investigates the hypothesis that UV-C in addition to daily cleaning leads to decreased patient acquisition of healthcare-associated bacteria.
This study is important to further advance hospital-based infection prevention knowledge of the impact of UV-C light for environmental cleaning.
Patient rooms are counted as enrolled since consent was waived and the number of participants is unknown. Total of 83 rooms.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Patient rooms are counted as enrolled since consent was waived and the number of participants is unknown. Total of 83 rooms.
| Arm | Type | Receives |
|---|---|---|
| UV-C light disinfection | Experimental | Other: UV-C light disinfectionDuring intervention UV-C light disinfection will be used in hospital patient rooms as an adjunct to routine daily and discharge cleaning. |
| Control | No intervention | –During control period there will be standard discharge and daily room cleaning only, with no UV-C light disinfection. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patient rooms in pre-selected hospital units within Johns Hopkins Hospital
Key exclusion criteria (1 listed)
- None, intervention is at level of the hospital unit, not the patient
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 |
|---|---|---|
| UV-C light disinfectionUV-C light disinfection will be used in hospital patient rooms as an adjunct to routine daily and discharge cleaning. | Other | UV-C light disinfection |
Primary outcome
Acquisition of Vancomycin Resistant Enterococcus
Time frame: 2 years
Rates of Vancomycin Resistant Enterococcus acquisition will be compared between intervention and control periods.
Acquisition of a composite rate of healthcare-associated bacteria: Vancomycin Resistant Enterococcus, Methicillin Resistant Staphylococcus Aureus, hospital-onset bacteremias, Clostridium difficile, and central line associated bloodstream infections.
Time frame: 2 years
Rates of Vancomycin Resistant Enterococcus, Methicillin Resistant Staphylococcus Aureus, hospital-onset bacteremias, multidrug resistant gram negative bacteria, Clostridium difficile, and central line associated bloodstream infections will be compared between intervention and control periods.
13 secondary outcomes
Acquisition of Vancomycin Resistant Enterococcus (clinical infection)
Time frame: 2 years
Acquisition of Vancomycin Resistant Enterococcus (colonization)
Time frame: 2 years
Acquisition of Clostridium difficile (infection)
Time frame: 2 years
Acquisition of Clostridium difficile (colonization or infection)
Time frame: 2 years
Acquisition of bacteremia
Time frame: 2 years
Acquisition of Methicillin Resistant Staphylococcus Aureus (clinical)
Time frame: 2 years
Acquisition of Methicillin Resistant Staphylococcus Aureus (colonization)
Time frame: 2 years
Acquisition of Methicillin Resistant Staphylococcus Aureus (clinical or colonization)
Time frame: 2 years
Acquisition of Central line associated bloodstream infections
Time frame: 2 years
Acquisition of multidrug resistant gram negative bacteria (colonization)
Time frame: 2 years
Acquisition of multidrug resistant gram negative bacteria
Time frame: 2 years
Differences in patient overall satisfaction with hospital stay as assessed by the Hospital Consumer Assessment of Healthcare Providers and Systems Survey.
Time frame: 2 years
Differences in patient satisfaction with environmental cleaning as assessed by the Hospital Consumer Assessment of Healthcare Providers and Systems Survey.
Time frame: 2 years
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 19 Sep 2018.
- Derived from this study: PubMed 34636853Rock C, Hsu YJ, Curless MS, Carroll KC, Ross Howard T, Carson KA, Cummings S, Anderson M, Milstone AM, Maragakis LL. Ultraviolet-C Light Evaluation as Adjunct Disinfection to Remove Multidrug-Resistant Organisms. Clin Infect Dis. 2022 Aug 24;75(1):35-40. doi: 10.1093/cid/ciab896.
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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.
Lisa Maragakis, MD, MPH principal investigator
Johns Hopkins University
Questions about this trial
What is this clinical trial studying?
A study testing UV-C light disinfection in people with Healthcare Associated Infection and Multidrug Resistant Organisms, run by Johns Hopkins University.
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: finished, as of the sponsor's last update on 19 Sep 2018. 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?
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?
Acquisition of Vancomycin Resistant Enterococcus (time frame: 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02605499, which also lists 1 linked publication.
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 19 Sep 2018.