Clinical trial NCT03268122: Comparison of Standard Isolation With Targeted Isolation for Preventing Nosocomial Transmission of MRSA and VRE
Official title: Comparison of Standard Isolation With Targeted Isolation for Preventing Nosocomial Transmission of MRSA and VRE: A Pilot Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: MRSA
VRE Infection
Keywords: Patient Isolation
Methicillin-Resistant Staphylococcus aureus
Vancomycin-Resistant Enterococci
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
First posted: 2017-08-31
Enrollment: 1974
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Multiple-crossover, cluster-randomized, controlled trial
Primary purpose: PREVENTION

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.

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.

Eligibility 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

Primary outcomes:
measure: Composite rate of ICU-acquired MRSA or VRE infections
timeFrame: 48 hours after enrollment to 48 hours after study ICU discharge, censored at 28 days after enrollment
Secondary outcomes:
measure: Rate of ICU-acquired MRSA infection
timeFrame: 48 hours after enrollment to 48 hours after study ICU discharge, censored at 28 days after enrollment
measure: Rate of ICU-acquired VRE infection
timeFrame: 48 hours after enrollment to 48 hours after study ICU discharge, censored at 28 days after enrollment
measure: Rate of ICU-acquired MRSA bacteremia
timeFrame: 48 hours after enrollment to 48 hours after study ICU discharge, censored at 28 days after enrollment
measure: Rate of ICU-acquired VRE bacteremia
timeFrame: 48 hours after enrollment to 48 hours after study ICU discharge, censored at 28 days after enrollment
measure: Composite rate of ICU-acquired MRSA or VRE bacteremia
timeFrame: 48 hours after enrollment to 48 hours after study ICU discharge, censored at 28 days after enrollment
measure: Composite rate of hospital-acquired MRSA or VRE infection
timeFrame: 48 hours after enrollment to 48 hours after study hospital discharge, truncated at 28 days after enrollment
measure: Composite rate of hospital-acquired CLABSI, CAUTI, BSI, Clostridium difficile infection, and VAP.
timeFrame: 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)
measure: 28-day mortality
timeFrame: Date of enrollment until 28 days after enrollment
measure: In-hospital mortality
timeFrame: Date of enrollment until hospital discharge, censored at 28 days after enrollment
measure: ICU mortality
timeFrame: Date of enrollment until study ICU discharge, censored at 28 days after enrollment
measure: ICU length of stay
timeFrame: Study enrollment until study ICU discharge, truncated at 28 days after enrollment
measure: Hospital length of stay
timeFrame: Study enrollment until study hospital discharge, truncated at 28 days after enrollment
measure: Proportion compliant with hand hygiene
timeFrame: Up to 8 months
measure: Proportion compliant with contact isolation
timeFrame: Up to 8 months
measure: Estimated cost of gowns and gloves
timeFrame: Up to 8 months
measure: Rate of gowns delivered to ICU per patient-day
timeFrame: Up to 8 months
measure: Rate of gloves delivered to ICU per patient-day
timeFrame: Up to 8 months
measure: Adverse events (composite of falls, medication administration errors, and pressure ulcers)
timeFrame: Study enrollment until study ICU discharge, truncated at 28 days after enrollment
measure: Falls
timeFrame: Study enrollment until study ICU discharge, truncated at 28 days after enrollment
measure: Medication administration errors
timeFrame: Study enrollment until study ICU discharge, truncated at 28 days after enrollment
measure: Pressure ulcers
timeFrame: Study enrollment until study ICU discharge, truncated at 28 days after enrollment
measure: New MRSA colonization
timeFrame: Study enrollment until study ICU discharge, truncated at 28 days after enrollment
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
Study officials:
affiliation: Vanderbilt University Medical Center
name: Todd W Rice, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Derde LPG, Cooper BS, Goossens H, Malhotra-Kumar S, Willems RJL, Gniadkowski M, Hryniewicz W, Empel J, Dautzenberg MJD, Annane D, Aragao I, Chalfine A, Dumpis U, Esteves F, Giamarellou H, Muzlovic I, Nardi G, Petrikkos GL, Tomic V, Marti AT, Stammet P, Brun-Buisson C, Bonten MJM; MOSAR WP3 Study Team. Interventions to reduce colonisation and transmission of antimicrobial-resistant bacteria in intensive care units: an interrupted time series study and cluster randomised trial. Lancet Infect Dis. 2014 Jan;14(1):31-39. doi: 10.1016/S1473-3099(13)70295-0. Epub 2013 Oct 23.