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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Four-arm Prospective, Multicenter Study to Assess the Efficacy, Effectiveness, and Feasibility of Enhanced Terminal Room Disinfection With Chlorine and UV Light Using Clinical and Microbiologic Outc

Brief Summary: 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.

Detailed Summary:

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 prospe
Sponsor: Duke University

Current Primary Outcome:

  • Clinical incidence rate of four target organisms among patients admitted to a study room [ Time Frame: 90 days ]
    Patients will be monitored for clinical cultures that grow one of four target organisms (MRSA, VRE, C. difficile, and MDR-Acinetobacter) following admission to a "seed" room. Cultures for vegetative bacteria (MRSA, VRE, Acinetobacter) will be included if obtained within 90 days of discharge from a seed room; cultures for C. difficile will be included if they are obtained within 28 days of discharge from a seed room.
  • Clinical incidence rate of C. difficile among patients admitted to a study room [ Time Frame: 28 days ]
    Patients will be monitored for clinical cultures that grow C. difficile following admission to a "seed" room.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Clinical incidence rate of target vegetative bacteria (MRSA, VRE, Acinetobacter) among patients admitted to a seed room. [ Time Frame: 90 days ]
    Patients will be monitored for clinical cultures that grow one of three target vegetative organisms (MRSA, VRE, and MDR-Acinetobacter) following admission to a "seed" room.
  • Clinical incidence rate of target organisms among all patients admitted to the hospital [ Time Frame: 90 days ]
    All hospitalized patients will be monitored for clinical cultures that grow one of four target organisms (MRSA, VRE, C. difficile, and MDR-Acinetobacter) regardless of exposure to seed room.
  • Clinical incidence rate of MRSA among all patients admitted to the hospital [ Time Frame: 90 days ]
    All hospitalized patients will be monitored for clinical cultures that grow MRSA regardless of exposure to seed room.
  • Clinical incidence rate of VRE among all patients admitted to the hospital [ Time Frame: 90 days ]
    All hospitalized patients will be monitored for clinical cultures that grow VRE regardless of exposure to seed room.
  • Clinical incidence rate of MDR-Acinetobacter among all patients admitted to the hospital [ Time Frame: 90 days ]
    All hospitalized patients will be monitored for clinical cultures that grow MDR-Acinetobacter regardless of exposure to seed room.
  • Clinical incidence rate of C. difficile among all patients admitted to the hospital [ Time Frame: 28 days ]
    All hospitalized patients will be monitored for clinical cultures that grow C. difficile regardless of exposure to seed room.
  • Incidence rate of healthcare-associated infections caused by target bacteria (MRSA, VRE, C. difficile, and MDR-Acinetobacter) among patients admitted to a seed room. [ Time Frame: Patients will be followed an average of 30 days ]
    Patients will be monitored for HAIs due to one of four target organisms (MRSA, VRE, C. difficile, and MDR-Acinetobacter) following admission to a "seed" room. NHSN definitions for HAIs will be used.
  • Incidence rate of healthcare-associated infections caused by MRSA among patients admitted to a seed room. [ Time Frame: Patients will be followed an average of 30 days ]
    Patients will be monitored for HAIs due to MRSA following admission to a "seed" room. NHSN definitions for HAIs will be used.
  • Incidence rate of healthcare-associated infections caused by VRE among patients admitted to a seed room. [ Time Frame: Patients will be followed an average of 30 days ]
    Patients will be monitored for HAIs due to VRE following admission to a "seed" room. NHSN definitions for HAIs will be used.
  • Incidence rate of healthcare-associated infections caused by MDR-Acinetobacter among patients admitted to a seed room. [ Time Frame: Patients will be followed an average of 30 days ]
    Patients will be monitored for HAIs due to MDR-Acinetobacter following admission to a "seed" room. NHSN definitions for HAIs will be used.
  • Incidence rate of healthcare-associated infections caused by MDR-Acinetobacter among all hospitalized patients. [ Time Frame: Patients will be followed an average of 30 days ]
    Patients will be monitored for HAIs due to MDR-Acinetobacter, regardless of exposure to seed room. NHSN definitions for HAIs will be used.
  • Incidence rate of healthcare-associated infections caused by MRSA among all hospitalized patients. [ Time Frame: Patients will be followed an average of 30 days ]
    Patients will be monitored for HAIs due to MRSA, regardless of exposure to seed room. NHSN definitions for HAIs will be used.
  • Incidence rate of healthcare-associated infections caused by VRE among all hospitalized patients. [ Time Frame: Patients will be followed an average of 30 days ]
    Patients will be monitored for HAIs due to VRE, regardless of exposure to seed room. NHSN definitions for HAIs will be used.
  • Incidence rate of healthcare-associated infections caused by target vegetative bacteria (MRSA, VRE, MDR-Acinetobacter) among all hospitalized patients. [ Time Frame: Patients will be followed an average of 30 days ]
    Patients will be monitored for HAIs due to MRSA, VRE, and MDR-Acinetobacter regardless of exposure to seed room. NHSN definitions for HAIs will be used.
  • Missed Opportunities [ Time Frame: each study period (6 months) ]
    Use of UV-C emitting devices will be monitored and "missed opportunities" (ie, UV-C emitter should have been used per protocol and was not) will b

    Original Secondary Outcome: Same as current

    Information By: Duke University

    Dates:
    Date Received: April 5, 2012
    Date Started: April 2012
    Date Completion:
    Last Updated: November 15, 2015
    Last Verified: November 2015