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Effectiveness of Enhanced Terminal Room Disinfection to Prevent Healthcare-associated Infections (HAIs)

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Duke University

Status

Completed

Conditions

Healthcare Associated Infections
Multidrug Resistant Organisms

Treatments

Other: Bleach
Other: Quaternary ammonium and UV-C light
Other: Quaternary ammonium
Other: Bleach and UV-C light

Study type

Interventional

Funder types

Other

Identifiers

NCT01579370
1U54CK000164-01 (U.S. NIH Grant/Contract)
Pro00032718

Details and patient eligibility

About

Enhanced terminal room disinfection is a novel, promising, but still unproven strategy for the prevention of healthcare-associated infections (HAIs) due to selected multidrug-resistant (MDR) bacterial pathogens. The investigators will perform a large prospective, multicenter study enhanced terminal room disinfection to 1) determine the efficacy and feasibility of enhanced terminal room disinfection strategies to prevent HAIs and 2) determine the impact of environmental contamination on acquisition of MDR-pathogens among hospitalized patients.

Full description

Meticulous and consistent use of hand hygiene before and after patient care remains the cornerstone of infection prevention in all health care settings. However, clean hands are not sufficient to prevent all healthcare-associated infections (HAIs), as 1) hands of healthcare workers easily become contaminated from contact with contaminated environmental surfaces in patient rooms after appropriate hand hygiene has been performed and before direct patient care and 2) direct contact by patients with preexisting contaminated environmental surfaces in their hospital rooms can lead to colonization or infection. Thus, novel strategies are needed to prevent HAIs, particularly those caused by multidrug-resistant (MDR) pathogens that persist in the environment such as methicillin-resistant Staphylococcus aureus (MRSA), vancomycin-resistant Enterococci (VRE), Clostridium difficile, and Acinetobacter.

Enhanced environmental disinfection methods may lead to reduced risk of exposure to or acquisition of HAIs and MDR-pathogens and overcome a critical issue facing healthcare today - hospitals rooms are often poorly cleaned and disinfected. Enhanced terminal room disinfection strategies using bleach and/or UV-C emitting devices have been investigated only in experimental conditions; the efficacy, effectiveness, and feasibility of enhanced terminal room disinfection to prevent HAIs are unknown. Thus, the scientific evidence for such interventions currently is insufficient for their inclusion in evidence-based guidelines.

This study will investigate the hypothesis that enhanced terminal room disinfection protocols (using chlorine-based cleaning agents with or without UV-C light-emitting devices) will decrease the overall risk of HAIs in the hospital and, more specifically, in subsequent patients who are cared for in the same room. This prospective investigation will employ a crossover design utilizing four room cleaning/disinfection protocols in 9 hospitals, including 2 tertiary care, 1 VA, and 6 community hospitals. Phase T2 data from this study will be useful in assessing the clinical efficacy and feasibility of individual disinfection strategies. Thus, the goals of the investigators proposed research are to 1) determine the efficacy and feasibility of enhanced terminal room disinfection strategies to prevent HAIs and 2) determine the impact of environmental contamination on acquisition of MDR-pathogens among hospitalized patients.

Enrollment

21,395 patients

Sex

All

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Any seed room (ie., room from which a patient with one of the target organisms has been transferred or discharged)

Exclusion criteria

  • None, intervention is at level of the room, not the patient
  • Patient outcomes will be excluded if clinical cultures are obtained within 48 hours of admission to the room of interest.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Factorial Assignment

Masking

None (Open label)

21,395 participants in 4 patient groups

Quaternary ammonium
Active Comparator group
Description:
Rooms will be terminally cleaned using quaternary ammonium-containing compounds, the reference standard for hospital cleaning in US hospitals.
Treatment:
Other: Quaternary ammonium
Bleach
Experimental group
Description:
Rooms will be terminally cleaned using bleach-containing products.
Treatment:
Other: Bleach
Quaternary ammonium and UV-C light
Experimental group
Description:
Rooms will be terminally cleaned with quaternary ammonium-containing solutions followed by irradiation by a UV-C light emitting device.
Treatment:
Other: Quaternary ammonium and UV-C light
Bleach and UV-C light
Experimental group
Description:
Rooms will be terminally cleaned with bleach-containing solutions followed by irradiation by a UV-C light emitting device.
Treatment:
Other: Bleach and UV-C light

Trial contacts and locations

9

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Data sourced from clinicaltrials.gov

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