MRSACONTACT-PILOTNCT03268122
Comparison of Standard Isolation With Targeted Isolation for Preventing Nosocomial Transmission of MRSA and VRE
A study testing Standard Contact Isolation and Targeted Contact Isolation in people with MRSA and VRE Infection, run by Vanderbilt University Medical Center at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- MRSA, VRE Infection
- What is being tested?
- Standard Contact Isolation and Targeted Contact Isolation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,974 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2017to 30 May 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All adult patients admitted to the study ICU, the Vanderbilt University Medical Center Medical Intensive Care Unit, during an active enrollment period
Who cannot join
- Age less than 18 years old
- Patients admitted during a run-in period
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt University Medical Center
Nashville, Tennessee, 37209
About this study
Official title: Comparison of Standard Isolation With Targeted Isolation for Preventing Nosocomial Transmission of MRSA and VRE: A Pilot Clinical Trial
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.
Read the 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.
- Conditions
- MRSA, VRE Infection
- Being tested
- Standard Contact Isolation, Targeted Contact Isolation
- Keywords
- Patient Isolation, Methicillin-Resistant Staphylococcus aureus, Vancomycin-Resistant Enterococci
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard Contact IsolationOther
Also called Standard Contact Precautions
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
Targeted Contact IsolationOther
Also called Targeted Contact Precautions
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.
| Study group | Role | What they receive |
|---|---|---|
| Standard Contact Isolation | Active comparator | 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. Receives: Other: Standard Contact Isolation |
| Targeted Contact Isolation | Active comparator | 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. Receives: Other: Targeted Contact Isolation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite rate of ICU-acquired MRSA or VRE infections
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.
Measured: 48 hours after enrollment to 48 hours after study ICU discharge, censored at 28 days after enrollment
Secondary outcomes (22)
Rate of ICU-acquired MRSA infection
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.
Measured: 48 hours after enrollment to 48 hours after study ICU discharge, censored at 28 days after enrollment
Rate of ICU-acquired VRE infection
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.
Measured: 48 hours after enrollment to 48 hours after study ICU discharge, censored at 28 days after enrollment
Rate of ICU-acquired MRSA bacteremia
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.
Measured: 48 hours after enrollment to 48 hours after study ICU discharge, censored at 28 days after enrollment
Rate of ICU-acquired VRE bacteremia
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.
Measured: 48 hours after enrollment to 48 hours after study ICU discharge, censored at 28 days after enrollment
Composite rate of ICU-acquired MRSA or VRE bacteremia
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.
Measured: 48 hours after enrollment to 48 hours after study ICU discharge, censored at 28 days after enrollment
Composite rate of hospital-acquired MRSA or VRE infection
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.
Measured: 48 hours after enrollment to 48 hours after study hospital discharge, truncated at 28 days after enrollment
Composite rate of hospital-acquired CLABSI, CAUTI, BSI, Clostridium difficile infection, and VAP.
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.
Measured: 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)
28-day mortality
All-cause mortality up until 28 days after enrollment, censored at hospital discharge
Measured: Date of enrollment until 28 days after enrollment
In-hospital mortality
All-cause death while admitted to the study hospital, truncated 28 days after enrollment
Measured: Date of enrollment until hospital discharge, censored at 28 days after enrollment
ICU mortality
All-cause death while admitted to the study ICU, truncated 28 days after enrollment
Measured: Date of enrollment until study ICU discharge, censored at 28 days after enrollment
ICU length of stay
Length of Stay in the ICU
Measured: Study enrollment until study ICU discharge, truncated at 28 days after enrollment
Hospital length of stay
Length of Stay in the Hospital
Measured: Study enrollment until study hospital discharge, truncated at 28 days after enrollment
Proportion compliant with hand hygiene
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.
Measured: Up to 8 months
Proportion compliant with contact isolation
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.
Measured: Up to 8 months
Estimated cost of gowns and gloves
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.
Measured: Up to 8 months
Rate of gowns delivered to ICU per patient-day
Number of gowns divided by patient ICU days
Measured: Up to 8 months
Rate of gloves delivered to ICU per patient-day
Number of gloves divided by patient ICU days
Measured: Up to 8 months
Adverse events (composite of falls, medication administration errors, and pressure ulcers)
Composite of falls, medication administration errors, and pressure ulcers, as defined in their respective outcomes
Measured: Study enrollment until study ICU discharge, truncated at 28 days after enrollment
Falls
Documented patient fall, regardless of degree of injury sustained
Measured: Study enrollment until study ICU discharge, truncated at 28 days after enrollment
Medication administration errors
Documented error in administration of medications to patients, regardless of any adverse effect on the patient
Measured: Study enrollment until study ICU discharge, truncated at 28 days after enrollment
Pressure ulcers
Documented new pressure ulcer
Measured: Study enrollment until study ICU discharge, truncated at 28 days after enrollment
New MRSA colonization
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).
Measured: Study enrollment until study ICU discharge, truncated at 28 days after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2017
- Study start1 Sep 2017
- Primary completion30 May 2018
- Study completion30 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for MRSAStudies of the same condition, open and under way.
- More trials run by Vanderbilt University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Multiple-crossover, cluster-randomized, controlled trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,974 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Todd Rice, Vanderbilt University Medical Center
- Investigators
- Todd W Rice, MD, MSc, Principal investigator, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03268122
- Sponsor's protocol ID
- 161137
- Acronym
- CONTACT-PILOT
- Status last verified
- Jun 2018
- First submitted
- 9 Aug 2017
- Last updated
- 14 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Huskins WC, Huckabee CM, O'Grady NP, Murray P, Kopetskie H, Zimmer L, Walker ME, Sinkowitz-Cochran RL, Jernigan JA, Samore M, Wallace D, Goldmann DA; STAR*ICU Trial Investigators. Intervention to reduce transmission of resistant bacteria in intensive care. N Engl J Med. 2011 Apr 14;364(15):1407-18. doi: 10.1056/NEJMoa1000373.
PubMed 21488763Harris AD, Pineles L, Belton B, Johnson JK, Shardell M, Loeb M, Newhouse R, Dembry L, Braun B, Perencevich EN, Hall KK, Morgan DJ; Benefits of Universal Glove and Gown (BUGG) Investigators; Shahryar SK, Price CS, Gadbaw JJ, Drees M, Kett DH, Munoz-Price LS, Jacob JT, Herwaldt LA, Sulis CA, Yokoe DS, Maragakis L, Lissauer ME, Zervos MJ, Warren DK, Carver RL, Anderson DJ, Calfee DP, Bowling JE, Safdar N. Universal glove and gown use and acquisition of antibiotic-resistant bacteria in the ICU: a randomized trial. JAMA. 2013 Oct 16;310(15):1571-80. doi: 10.1001/jama.2013.277815.
PubMed 24097234Huang SS, Septimus E, Kleinman K, Moody J, Hickok J, Avery TR, Lankiewicz J, Gombosev A, Terpstra L, Hartford F, Hayden MK, Jernigan JA, Weinstein RA, Fraser VJ, Haffenreffer K, Cui E, Kaganov RE, Lolans K, Perlin JB, Platt R; CDC Prevention Epicenters Program; AHRQ DECIDE Network and Healthcare-Associated Infections Program. Targeted versus universal decolonization to prevent ICU infection. N Engl J Med. 2013 Jun 13;368(24):2255-65. doi: 10.1056/NEJMoa1207290. Epub 2013 May 29.
PubMed 23718152Morgan DJ, Murthy R, Munoz-Price LS, Barnden M, Camins BC, Johnston BL, Rubin Z, Sullivan KV, Shane AL, Dellinger EP, Rupp ME, Bearman G. Reconsidering contact precautions for endemic methicillin-resistant Staphylococcus aureus and vancomycin-resistant Enterococcus. Infect Control Hosp Epidemiol. 2015 Oct;36(10):1163-72. doi: 10.1017/ice.2015.156. Epub 2015 Jul 3.
PubMed 26138329Derde 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.
PubMed 24161233
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Standard Isolation With Targeted Isolation for Preventing Nosocomial Transmission of MRSA and VRE: A Pilot Clinical Trial
- ClinicalTrials.gov ID
- NCT03268122
- Acronym / sponsor ID
- CONTACT-PILOT / 161137
- Conditions
- MRSA, VRE Infection
- Keywords
- Patient Isolation, Methicillin-Resistant Staphylococcus aureus, Vancomycin-Resistant Enterococci
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,974 participants (actual)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Study start
- 1 Sep 2017 (actual)
- Primary completion
- 30 May 2018 (actual)
- Study completion
- 30 May 2018 (actual)
- First posted
- 31 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Multiple-crossover, cluster-randomized, controlled trial
| Arm | Type | Receives |
|---|---|---|
| Standard Contact Isolation | Active comparator | Other: Standard Contact IsolationPatients 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. |
| Targeted Contact Isolation | Active comparator | Other: Targeted Contact IsolationPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All adult patients admitted to the study ICU, the Vanderbilt University Medical Center Medical Intensive Care Unit, during an active enrollment period
Key exclusion criteria (2 listed)
- Age less than 18 years old
- Patients admitted during a run-in period
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard Contact IsolationAlso: Standard Contact PrecautionsWith 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 | Standard Contact Isolation |
| Targeted Contact IsolationAlso: Targeted Contact PrecautionsWith 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 | Targeted Contact Isolation |
Primary outcome
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.
22 secondary outcomes
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
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
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
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
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
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
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)
28-day mortality
Time frame: Date of enrollment until 28 days after enrollment
In-hospital mortality
Time frame: Date of enrollment until hospital discharge, censored at 28 days after enrollment
ICU mortality
Time frame: Date of enrollment until study ICU discharge, censored at 28 days after enrollment
ICU length of stay
Time frame: Study enrollment until study ICU discharge, truncated at 28 days after enrollment
Hospital length of stay
Time frame: Study enrollment until study hospital discharge, truncated at 28 days after enrollment
Proportion compliant with hand hygiene
Time frame: Up to 8 months
Proportion compliant with contact isolation
Time frame: Up to 8 months
Estimated cost of gowns and gloves
Time frame: Up to 8 months
Rate of gowns delivered to ICU per patient-day
Time frame: Up to 8 months
Rate of gloves delivered to ICU per patient-day
Time frame: Up to 8 months
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
Falls
Time frame: Study enrollment until study ICU discharge, truncated at 28 days after enrollment
Medication administration errors
Time frame: Study enrollment until study ICU discharge, truncated at 28 days after enrollment
Pressure ulcers
Time frame: Study enrollment until study ICU discharge, truncated at 28 days after enrollment
New MRSA colonization
Time frame: Study enrollment until study ICU discharge, truncated at 28 days after enrollment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2018.
- Background: PubMed 21488763Huskins WC, Huckabee CM, O'Grady NP, Murray P, Kopetskie H, Zimmer L, Walker ME, Sinkowitz-Cochran RL, Jernigan JA, Samore M, Wallace D, Goldmann DA; STAR*ICU Trial Investigators. Intervention to reduce transmission of resistant bacteria in intensive care. N Engl J Med. 2011 Apr 14;364(15):1407-18. doi: 10.1056/NEJMoa1000373.
- Background: PubMed 24097234Harris AD, Pineles L, Belton B, Johnson JK, Shardell M, Loeb M, Newhouse R, Dembry L, Braun B, Perencevich EN, Hall KK, Morgan DJ; Benefits of Universal Glove and Gown (BUGG) Investigators; Shahryar SK, Price CS, Gadbaw JJ, Drees M, Kett DH, Munoz-Price LS, Jacob JT, Herwaldt LA, Sulis CA, Yokoe DS, Maragakis L, Lissauer ME, Zervos MJ, Warren DK, Carver RL, Anderson DJ, Calfee DP, Bowling JE, Safdar N. Universal glove and gown use and acquisition of antibiotic-resistant bacteria in the ICU: a randomized trial. JAMA. 2013 Oct 16;310(15):1571-80. doi: 10.1001/jama.2013.277815.
- Background: PubMed 23718152Huang SS, Septimus E, Kleinman K, Moody J, Hickok J, Avery TR, Lankiewicz J, Gombosev A, Terpstra L, Hartford F, Hayden MK, Jernigan JA, Weinstein RA, Fraser VJ, Haffenreffer K, Cui E, Kaganov RE, Lolans K, Perlin JB, Platt R; CDC Prevention Epicenters Program; AHRQ DECIDE Network and Healthcare-Associated Infections Program. Targeted versus universal decolonization to prevent ICU infection. N Engl J Med. 2013 Jun 13;368(24):2255-65. doi: 10.1056/NEJMoa1207290. Epub 2013 May 29.
- Background: PubMed 26138329Morgan DJ, Murthy R, Munoz-Price LS, Barnden M, Camins BC, Johnston BL, Rubin Z, Sullivan KV, Shane AL, Dellinger EP, Rupp ME, Bearman G. Reconsidering contact precautions for endemic methicillin-resistant Staphylococcus aureus and vancomycin-resistant Enterococcus. Infect Control Hosp Epidemiol. 2015 Oct;36(10):1163-72. doi: 10.1017/ice.2015.156. Epub 2015 Jul 3.
- Background: PubMed 24161233Derde 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Todd W Rice, MD, MSc principal investigator
Vanderbilt University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard Contact Isolation and Targeted Contact Isolation in people with MRSA and VRE Infection, run by Vanderbilt University Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03268122, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jun 2018.