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Comparison of Standard Isolation With Targeted Isolation for Preventing Nosocomial Transmission of MRSA and VRE (CONTACT-PILOT)

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ClinicalTrials.gov Identifier: NCT03268122
Recruitment Status : Completed
First Posted : August 31, 2017
Last Update Posted : June 14, 2018
Sponsor:
Information provided by (Responsible Party):
Todd Rice, Vanderbilt University Medical Center

Brief Summary:
Hospital-acquired infections are common and frequently lead to poor outcomes, including death, in affected patients. Two common organisms that cause infections in the hospital are methicillin-resistant Staphylococcus aureus (MRSA) and vancomycin-resistant Enterococcus (VRE). One strategy used to prevent these infections is contact isolation of hospitalized patients with MRSA and/or VRE. It is unclear whether contact isolation decreases the rate of infection with MRSA and/or VRE. The CONTACT-PILOT study is designed to test the hypothesis that contact isolation decreases the rate of infection with MRSA and/or VRE in patients in the intensive care unit (ICU). The study will enroll all adults in the Medical ICU and will run between September 2017 and April 2018. During some months, all patients in the Medical ICU patients will be placed in isolation for MRSA or VRE if they have a current infection or colonization with either organism, or a recent history thereof. During other months, patients will only be placed in isolation for MRSA or VRE if they have an active, highly-transmissible infection with either organism, such as a pneumonia or an open, draining wound.

Condition or disease Intervention/treatment Phase
MRSA VRE Infection Other: Standard Contact Isolation Other: Targeted Contact Isolation Not Applicable

Detailed Description:
CONTACT-PILOT is a single center, pilot, multiple crossover, cluster-randomized trial of contact isolation for MRSA and VRE in the Vanderbilt Medical Intensive Care Unit (MICU) in order to determine if contact isolation reduces the rate of ICU-acquired infection with MRSA and/or VRE. Specifically, the study will randomly assign the entire MICU to one of two contact isolation strategies for 2 months, and then switch the entire MICU over to the second strategy. The first strategy is the current practice, also referred to as standard contact isolation, which is to place all patients with MRSA and/or VRE infection or colonization (or a history of either) on contact isolation. The second strategy is targeted contact isolation, in which patients with MRSA and/or VRE would only be placed on contact isolation if they have an active infection with one (or both) of these organisms with a high risk of transmission, such as an open, draining wound or a pneumonia. The study will be divided into four alternating 2-month treatment blocks, two for each strategy, with one "run-in" week at the start of each treatment block in order to transition between the two treatment strategies, for a total study duration of 8 months. The interventions will occur between September 1, 2017 and April 30, 2018. All adult MICU patients will be enrolled in the study. The primary outcome will be the rate of new ICU-acquired MRSA and VRE infections. Data analysis will be performed using a pre-specified data analysis plan. This study is being performed as a preliminary study to evaluate the feasibility and safety of the study plan.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1974 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Multiple-crossover, cluster-randomized, controlled trial
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Comparison of Standard Isolation With Targeted Isolation for Preventing Nosocomial Transmission of MRSA and VRE: A Pilot Clinical Trial
Actual Study Start Date : September 1, 2017
Actual Primary Completion Date : May 30, 2018
Actual Study Completion Date : May 30, 2018

Arm Intervention/treatment
Active Comparator: Standard Contact Isolation
Patients in the standard contact isolation arm will be under the standard contact isolation strategy during the entire time they are physically located in the Medical ICU.
Other: Standard Contact Isolation
With regards to MRSA and VRE, the wearing of gowns and gloves will be required for all staff entering a patient room if the patent has an infection or colonization with MRSA or VRE or a recent history (within 90 days) of either
Other Name: Standard Contact Precautions

Active Comparator: Targeted Contact Isolation
Patients in the targeted contact isolation arm will be under the targeted contact isolation strategy during the entire time they are physically located in the Medical ICU.
Other: Targeted Contact Isolation

With regards to MRSA and VRE, the wearing of gowns and gloves will be required for all staff entering a patient room if the patient has an active, highly-transmissible infection with MRSA and/or VRE.

A highly-transmissible infection is defined as one with uncontained secretions or excretions (diarrhea, vomiting, or open draining wounds) or pneumonia.

Other Name: Targeted Contact Precautions




Primary Outcome Measures :
  1. Composite rate of ICU-acquired MRSA or VRE infections [ Time Frame: 48 hours after enrollment to 48 hours after study ICU discharge, censored at 28 days after enrollment ]
    The primary endpoint is defined as an MRSA or VRE infection in a patient not currently diagnosed with or being treated for that infection at least 48 hours after admission to the study ICU and while the patient either remains in the study ICU or is within 48 hours of discharge or transfer from the study ICU, truncated at day 28 after enrollment. The composite rate will be reported in infections per 1000 patient-days.


Secondary Outcome Measures :
  1. Rate of ICU-acquired MRSA infection [ Time Frame: 48 hours after enrollment to 48 hours after study ICU discharge, censored at 28 days after enrollment ]
    An MRSA infection in a patient not currently diagnosed with or being treated for that infection at least 48 hours after admission to the study ICU and while the patient either remains in the study ICU or is within 48 hours of discharge or transfer from the study ICU, truncated at day 28 after enrollment. The rate will be reported in infections per 1000 patient-days.

  2. Rate of ICU-acquired VRE infection [ Time Frame: 48 hours after enrollment to 48 hours after study ICU discharge, censored at 28 days after enrollment ]
    A VRE infection in a patient not currently diagnosed with or being treated for that infection at least 48 hours after admission to the study ICU and while the patient either remains in the study ICU or is within 48 hours of discharge or transfer from the study ICU, truncated at day 28 after enrollment. The rate will be reported in infections per 1000 patient-days.

  3. Rate of ICU-acquired MRSA bacteremia [ Time Frame: 48 hours after enrollment to 48 hours after study ICU discharge, censored at 28 days after enrollment ]
    A positive clinical blood culture for MRSA in a patient not currently diagnosed with or being treated with that infection at least 48 hours after admission to the study ICU and while the patient either remains in the study ICU or is within 48 hours of discharge or transfer from the study ICU, truncated at day 28 after enrollment. The rate will be reported in infections per 1000 patient-days.

  4. Rate of ICU-acquired VRE bacteremia [ Time Frame: 48 hours after enrollment to 48 hours after study ICU discharge, censored at 28 days after enrollment ]
    A positive clinical blood culture for VRE in a patient not currently diagnosed with or being treated for that infection at least 48 hours after admission to the study ICU and while the patient either remains in the study ICU or is within 48 hours of discharge or transfer from the study ICU, truncated at day 28 after enrollment. The rate will be reported in infections per 1000 patient-days.

  5. Composite rate of ICU-acquired MRSA or VRE bacteremia [ Time Frame: 48 hours after enrollment to 48 hours after study ICU discharge, censored at 28 days after enrollment ]
    A clinical blood culture positive for either MRSA or VRE in a patient not currently diagnosed with or being treated for that infection at least 48 hours after admission to the study ICU and while the patient either remains in the study ICU or is within 48 hours of discharge or transfer from the study ICU, truncated at day 28 after enrollment. The composite rate will be reported in infections per 1000 patient-days.

  6. Composite rate of hospital-acquired MRSA or VRE infection [ Time Frame: 48 hours after enrollment to 48 hours after study hospital discharge, truncated at 28 days after enrollment ]
    An MRSA or VRE infection in a patient not currently diagnosed with or being treated for that infection at least 48 hours after admission to the study ICU and while the patient either remains admitted to the study hospital or is within 48 hours of discharge or transfer from the study hospital, truncated at day 28 after enrollment. The composite rate will be reported in infections per 1000 patient-days.

  7. Composite rate of hospital-acquired CLABSI, CAUTI, BSI, Clostridium difficile infection, and VAP. [ Time Frame: 48 hours after enrollment to 48 hours after study ICU discharge, truncated at day 28 after enrollment (except for Clostridium difficile infections, which are truncated at the time of study ICU discharge) ]
    Composite rate of certain healthcare-associated infections: central line-associated bloodstream infection (CLABSI), catheter-associated urinary tract infection (CAUTI), bloodstream infection (BSI), Clostridium difficile infection, and ventilator-associated pneumonia (VAP) in patients not currently diagnosed with or being treated for those infections, truncated at day 28 after enrollment.

  8. 28-day mortality [ Time Frame: Date of enrollment until 28 days after enrollment ]
    All-cause mortality up until 28 days after enrollment, censored at hospital discharge

  9. In-hospital mortality [ Time Frame: Date of enrollment until hospital discharge, censored at 28 days after enrollment ]
    All-cause death while admitted to the study hospital, truncated 28 days after enrollment

  10. ICU mortality [ Time Frame: Date of enrollment until study ICU discharge, censored at 28 days after enrollment ]
    All-cause death while admitted to the study ICU, truncated 28 days after enrollment

  11. ICU length of stay [ Time Frame: Study enrollment until study ICU discharge, truncated at 28 days after enrollment ]
    Length of Stay in the ICU

  12. Hospital length of stay [ Time Frame: Study enrollment until study hospital discharge, truncated at 28 days after enrollment ]
    Length of Stay in the Hospital

  13. Proportion compliant with hand hygiene [ Time Frame: Up to 8 months ]
    Compliance by staff members with hand hygiene will be defined as using alcohol-based foam and/or soap and water immediately before entering a patient room and immediately after exiting a patient room, unless the patient specifically requires soap and water to be utilized after exiting their patient room (e.g. a patient with Clostridium difficile infection), in which case compliance after exiting that patient room would only be achieved by handwashing with soap and water.

  14. Proportion compliant with contact isolation [ Time Frame: Up to 8 months ]
    Compliance with contact isolation precautions by staff members will be defined as donning gown and gloves immediately prior to entering a patient room and removal of both of these items immediately before exiting a patient room.

  15. Estimated cost of gowns and gloves [ Time Frame: Up to 8 months ]
    This outcome will be calculated from the rate of gowns and gloves delivered to the ICU and the cost of gowns and gloves immediately prior to the start of the study.

  16. Rate of gowns delivered to ICU per patient-day [ Time Frame: Up to 8 months ]
    Number of gowns divided by patient ICU days

  17. Rate of gloves delivered to ICU per patient-day [ Time Frame: Up to 8 months ]
    Number of gloves divided by patient ICU days

  18. Adverse events (composite of falls, medication administration errors, and pressure ulcers) [ Time Frame: Study enrollment until study ICU discharge, truncated at 28 days after enrollment ]
    Composite of falls, medication administration errors, and pressure ulcers, as defined in their respective outcomes

  19. Falls [ Time Frame: Study enrollment until study ICU discharge, truncated at 28 days after enrollment ]
    Documented patient fall, regardless of degree of injury sustained

  20. Medication administration errors [ Time Frame: Study enrollment until study ICU discharge, truncated at 28 days after enrollment ]
    Documented error in administration of medications to patients, regardless of any adverse effect on the patient

  21. Pressure ulcers [ Time Frame: Study enrollment until study ICU discharge, truncated at 28 days after enrollment ]
    Documented new pressure ulcer

  22. New MRSA colonization [ Time Frame: Study enrollment until study ICU discharge, truncated at 28 days after enrollment ]
    Patient with admission surveillance culture negative for MRSA but with discharge surveillance culture positive for MRSA (collected during the final 4 months of the study).



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • All adult patients admitted to the study ICU, the Vanderbilt University Medical Center Medical Intensive Care Unit, during an active enrollment period

Exclusion Criteria:

  • Age less than 18 years old
  • Patients admitted during a run-in period

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03268122


Locations
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United States, Tennessee
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37209
Sponsors and Collaborators
Vanderbilt University Medical Center
Investigators
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Principal Investigator: Todd W Rice, MD, MSc Vanderbilt University Medical Center

Publications:

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Responsible Party: Todd Rice, Associate Professor of Medicine, Vanderbilt University Medical Center
ClinicalTrials.gov Identifier: NCT03268122     History of Changes
Other Study ID Numbers: 161137
First Posted: August 31, 2017    Key Record Dates
Last Update Posted: June 14, 2018
Last Verified: June 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Todd Rice, Vanderbilt University Medical Center:
Patient Isolation
Methicillin-Resistant Staphylococcus aureus
Vancomycin-Resistant Enterococci