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Completed

NCT Number: NCT03268122

Comparison of Standard Isolation With Targeted Isolation for Preventing Nosocomial Transmission of MRSA and VRE

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.

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Key information

Conditions

MRSA VRE Infection

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Vanderbilt University Medical Center

Nashville, Tennessee, 37209, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Standard Contact Isolation

Other

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 names: Standard Contact Precautions

Targeted Contact Isolation

Other

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 names: Targeted Contact Precautions

Primary outcomes

  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 outcomes

  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).

Sponsors and collaborators

Lead sponsor

Vanderbilt University Medical Center

Other

Registry information

Official study title

Comparison of Standard Isolation With Targeted Isolation for Preventing Nosocomial Transmission of MRSA and VRE: A Pilot Clinical Trial

Acronym: CONTACT-PILOT

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Aug 31, 2017
Registry last updated
Jun 14, 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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