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Completed

NCT Number: NCT02605499

Ultra Violet-C Light Evaluation as an Adjunct to Removing Multi-Drug Resistant Organisms (UVCLEAR-MDRO)

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.

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Key information

Conditions

Healthcare Associated Infection Cross Infection Disease Attributes Iatrogenic Disease Infections Multidrug Resistant Organisms Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

16 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patient rooms in pre-selected hospital units within Johns Hopkins Hospital

Exclusion criteria

  • None, intervention is at level of the hospital unit, not the patient

Treatment and study plan

UV-C light disinfection

Other

UV-C light disinfection will be used in hospital patient rooms as an adjunct to routine daily and discharge cleaning.

Primary outcomes

  1. Acquisition of Vancomycin Resistant Enterococcus

    Time frame: 2 years

    Rates of Vancomycin Resistant Enterococcus acquisition will be compared between intervention and control periods.

  2. 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.

Secondary outcomes

  1. Acquisition of Vancomycin Resistant Enterococcus (clinical infection)

    Time frame: 2 years

    Rates of Vancomycin Resistant Enterococcus acquisition (clinical infection) will be compared between intervention and control periods.

  2. Acquisition of Vancomycin Resistant Enterococcus (colonization)

    Time frame: 2 years

    Rates of Vancomycin Resistant Enterococcus acquisition (colonization) will be compared between intervention and control periods.

  3. Acquisition of Clostridium difficile (infection)

    Time frame: 2 years

    Rates of Clostridium difficile infection will be compared between intervention and control periods.

  4. Acquisition of Clostridium difficile (colonization or infection)

    Time frame: 2 years

    Rates of Clostridium difficile (colonization or infection) will be compared between the intervention and control arms.

  5. Acquisition of bacteremia

    Time frame: 2 years

    Rates of hospital onset bacteremia will be compared between the intervention and control arms.

  6. Acquisition of Methicillin Resistant Staphylococcus Aureus (clinical)

    Time frame: 2 years

    Rates of Methicillin Resistant Staphylococcus Aureus acquisition (clinical infection) will be compared between intervention and control periods.

  7. Acquisition of Methicillin Resistant Staphylococcus Aureus (colonization)

    Time frame: 2 years

    Rates of Methicillin Resistant Staphylococcus Aureus acquisition (colonization) will be compared between intervention and control periods.

  8. Acquisition of Methicillin Resistant Staphylococcus Aureus (clinical or colonization)

    Time frame: 2 years

    Rates of Methicillin Resistant Staphylococcus Aureus acquisition (clinical or colonization) will be compared between intervention and control periods.

  9. Acquisition of Central line associated bloodstream infections

    Time frame: 2 years

    Rates of Central line associated bloodstream infections in intervention and control arms will be compared.

  10. Acquisition of multidrug resistant gram negative bacteria (colonization)

    Time frame: 2 years

    Rates of multidrug resistant gram negative bacteria acquisition (colonization) will be compared between intervention and control periods.

  11. Acquisition of multidrug resistant gram negative bacteria

    Time frame: 2 years

    Rates of multidrug resistant gram negative bacteria acquisition will be compared between intervention and control periods.

  12. 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

    Patient satisfaction with overall hospital stay will be compared between intervention and control arms.

  13. Differences in patient satisfaction with environmental cleaning as assessed by the Hospital Consumer Assessment of Healthcare Providers and Systems Survey.

    Time frame: 2 years

    Patient satisfaction with environmental cleaning will be compared between intervention and control arms.

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Registry information

Acronym: UVCLEAR-MDRO

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Nov 16, 2015
Registry last updated
Sep 19, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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