MRSABUGGNCT01318213
Benefits of Universal Glove and Gowning
An observational study of MRSA and VRE, run by University of Maryland, Baltimore at 1 site in United States.
Trial summary
This study will test if doctors, nurses and other people who take care of patients in hospitals wearing gloves and gown for all contact with patients in an intensive care unit (ICU) will: Decrease the chance of patients getting an infection while in the hospital Decrease the chance of patients picking up bacteria as a… Read more about this study
- Who is it for?
- Ages 18 years and older
- How many people
- 19,856 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2010to 16 Oct 2013
- Phase
- Observational
- 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
Study population: Adult patients in medical, surgical or combined medical/surgical ICUs.
Who may be able to join
- ICUs to be included are: adult medical, surgical or combined medical surgical ICU as defined below:
- Medical ICU (MICU) > 80% of patients have a medical condition and have not undergone a surgical procedure during the current hospital stay
- Surgical ICU (SICU) > 80% of the patients have undergone a surgical procedure during the current hospital stay
- Combined Medical/Surgical ICU (MICU/SICU) - a roughly equivalent mixture of patients with medical conditions who have not undergone surgical procedures and patients who have undergone surgical procedures during the current hospital stay. Each group makes up > 20% and less than 80% of the total number of patients
- Ability to collect the data required for analysis
- Written approval of the study from the institution's IRB. The institution may opt to use the IRB approval provided by the centralized IRB at the University of Maryland, School of Medicine
Show all 9Show fewer
- Memorandum of Understanding signed by the ICU Medical Director, ICU Nurse Manager or Director and the Hospital Epidemiologist indicating a commitment to supporting enrollment of an ICU and completion the study
- Ability to be matched with another ICU based on baseline acquisition of resistant bacteria on culture
- Agreement to not perform active surveillance for MRSA or VRE that will be fed back to patients during the study period
Who cannot join
- Pediatric ICUs and other non-medical or non-surgical ICUs will be excluded
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Maryland, Baltimore
Baltimore, Maryland, 21201
About this study
Official title: Effect of the Use of Universal Glove and Gowning on Healthcare Associated Infection Rates and Antibiotic Resistant Bacteria
This study will test if doctors, nurses and other people who take care of patients in hospitals wearing gloves and gown for all contact with patients in an intensive care unit (ICU) will:
- Decrease the chance of patients getting an infection while in the hospital
- Decrease the chance of patients picking up bacteria as a result of being in the hospital
- Decrease the time a patient spends in the ICU or in the hospital
- Increase the frequency of adverse events
Read more
The study will also look at whether making doctors, nurses and other people who take care of patients wear gloves and gown for all contact with patients will decrease the amount of time healthcare workers spend with patients.
This study will gather information by comparing what happens in ICUs that continue to do what they were doing before the study with what happens in ICUs that require healthcare workers to wear gloves and gown for all contact with patients.
This study will provide information that will help to make being in the hospital safer for all patients.
Read the detailed description
GOAL:
The overall goal of this project is to determine the effectiveness of universal glove and gowning procedures in reducing healthcare-associated infection (HAI) rates and acquisition of antibiotic-resistant bacteria in the Intensive Care Unit (ICU). More specifically, this project requires that a cluster-randomized trial (CRT) be designed and conducted to compare the effects of universal glove and gowning procedures as compared to the current standard of care in ICUs.
STUDY DESIGN: The study is a two arm, cluster-randomized trial. Randomization and analysis will be performed at the ICU level. A secondary statistical analysis will be performed at the patient level.
STUDY POPULATION: Adult patients in medical, surgical or combined medical/surgical ICUs.
SAMPLE SIZE: Based on the power calculations presented in Appendix I for each of the CRT aims, the study will use at least 18 ICU sites, half for the universal gown and glove intervention and half for CDC standards of care only. We will seek to maximize the number of ICUs involved to improve the scientific value of the study. The study is presently powered for a 1-year intervention study if 18 ICUs are included. After the 2 month pre-randomization period, we will use the actual number of sites enrolled and our baseline estimates to see if we can achieve the same degree of power for a study intervention of less than a year.
We have been able to recruit and retain 20 ICU sites. Upon completion of the pre-randomization period and based upon revised power calculations we will complete a 9-month intervention.
RANDOMIZATION: Randomization with pair matching based on the baseline data collection of outcomes will be used.
DATA ANALYSIS: Analyses of all aims will be performed according to the intention-to-treat (ITT) paradigm at the ICU level and will accommodate the matched-pairs design.
INTERVENTION:
Aim 1: Perform a CRT in which healthcare workers in the intervention ICUs will wear gloves and gowns for all patient contact while the control units perform regular standard and contact precautions per CDC guidelines in their respective ICUs.
Aim 1a: Measure the colonization acquisition rates of antibiotic-resistant pathogens in both intervention and non-intervention ICUs.
Aim 1b: Measure the HAI rates of catheter-associated bloodstream infection, catheter-associated urinary tract infection and ventilator-associated pneumonia in both intervention and non-intervention ICUs.
Aim 1c: Measure in-hospital 30-day mortality in both intervention and non-intervention ICUs.
Aim 1d: Measure hospital length of stay in both intervention and non-intervention ICUs.
Aim 1e: Measure the frequency of adverse events including frequency of healthcare worker visits and frequency of adverse events using an IHI adverse event tool.
Aim 1f: Statistically determine whether the intervention was effective in decreasing acquisition of antibiotic-resistant bacteria (primary outcome), reducing HAI rates (secondary outcome), decreasing in-hospital 30-day mortality (secondary outcome), decreasing length of stay (secondary outcome) and not increasing adverse events (secondary outcome).
HYPOTHESES:
Hypothesis 1a: Healthcare workers wearing gloves and gowns during all patient contact in the ICU setting will reduce antibiotic-resistant pathogen acquisition in at-risk patients.
Hypothesis 1b: Healthcare workers wearing gloves and gowns during all patient contact in the ICU setting will decrease HAI rates.
Hypothesis 1c: Healthcare workers wearing gloves and gowns during all patient contact in the ICU setting will decrease 30-day mortality.
Hypothesis 1d: Healthcare workers wearing gloves and gowns during all patient contact in the ICU setting will decrease hospital length of stay.
Hypothesis 1e: Healthcare workers wearing gloves and gowns during all patient contact in the ICU setting will not lead to an increase of adverse events.
CRITERIA FOR EVALUATION:
Primary Outcome:
The primary outcome of interest is the acquisition of an antibiotic-resistant pathogen, specifically Vancomycin-resistant Enterococcus (VRE) or Methicillin Resistant Staphylococcus Aureus(MRSA), as determined by peri-anal surveillance cultures for VRE and by nasal surveillance cultures for MRSA. The outcomes will be analyzed both individually and collectively (i.e., VRE, MRSA and VRE or MRSA).
Acquisition will be defined as:
- A patient who has an initial ICU surveillance culture that is negative for an antibiotic-resistant pathogen and
- Any subsequent surveillance culture within the same ICU admission that is positive for an antibiotic-resistant pathogen.
Secondary Outcomes:
The HAI rates to be measured will consist of catheter-associated bloodstream infection, catheter-associated urinary tract infection and ventilator-associated pneumonia rates. Hospital length of stay and 30-day mortality will also be measured as secondary outcomes. Adverse events are also a secondary outcome and will be measured using the frequency of healthcare worker visits and the frequency of adverse events as measured by an IHI tool.
- Keywords
- VRE, MRSA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Arm | The intervention will consist of wearing gloves and gowns for all patient contact in the ICUs that are randomized to receive the intervention. During the intervention phases of the study, all healthcare workers (nurses, physicians, nurse extenders, respiratory therapists, social workers etc.) in the intervention group will be required to wear gloves and gowns for patient contact and when entering any patient room. In essence, healthcare workers will apply the CDC Contact Precautions guidelines for ALL patients. | |
| Non-intervention - Usual Standard of Care | The non-intervention units will follow their present standard of care. For all of these units, this will consist of healthcare workers following Contact Precautions (gloves and gowns) only for patients known to have antibiotic-resistant bacteria such as VRE and MRSA based on previous admission clinical and surveillance cultures or clinical cultures from the present admission. This represents on average 20-25% of patients on Contact Precautions. For the rest of the patients standard precautions will be followed. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of ICU Patients Who Acquire VRE or MRSA
The outcome of interest is the acquisition of VRE or MRSA as determined by peri-anal surveillance cultures for VRE and by nasal surveillance cultures for MRSA. The outcomes will be analyzed both individually and collectively.
Acquisition will be defined as:
- A patient who has an initial ICU surveillance culture that is negative for an antibiotic-resistant pathogen.
- Subsequent discharge surveillance culture within the same ICU admission that is positive for an antibiotic-resistant pathogen.
Measured: 9 months
Secondary outcomes (6)
Number of ICU Patients Who Acquire CABSI
In all of the intensive-care units, catheter-associated bloodstream infection, catheter-associated urinary tract infection and ventilator-associated pneumonia rates will be measured in a standardized fashion at the cluster or group level. Data is collected on an individual patient basis in a de-identified fashion and will be reported to investigators at the cluster level
Measured: 9 months
Number of ICU Patients Who Acquire CAUTI
In all of the intensive-care units, catheter-associated urinary tract infection rates will be measured in a standardized fashion at the cluster or group level. Data is collected on an individual patient basis in a de-identified fashion and will be reported to investigators at the cluster level
Measured: 9 months
Number of ICU Patients Who Acquire VAP
In all of the intensive-care units, ventilator-associated pneumonia rates will be measured in a standardized fashion at the cluster or group level. Data is collected on an individual patient basis in a de-identified fashion and will be reported to investigators at the cluster level
Measured: 9 months
Changes from Baseline in 30-day Mortality Rate
Thirty-day mortality will be a binary outcome of either the patient died at 30-days or was alive at 30-days after ICU admission date. This information will be recorded on an individual basis by the coordinator but will be reported on a group-level to the research center.
Measured: 9 months
Changes from Baseline in ICU LOS
ICU length of stay will be a continuous variable. This information will be recorded on an individual basis by the coordinator but will be reported on a group-level to the research center.
Measured: 9 months
Number of Adverse Events Occuring in the ICU
The study will look at a number of adverse events including 30-day mortality and the frequency of healthcare worker visits. Compliance with hand hygiene and the frequency of adverse events as measured by a modified Institute for Healthcare Improvement (IHI) trigger tool.
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2011 (estimated)
- Study startDec 2010
- Primary completion4 Oct 2012
- Study completion16 Oct 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for MRSAStudies of the same condition, open and under way.
- More trials run by University of Maryland, BaltimoreThe 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 19,856 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Maryland, Baltimore
- Sponsor type
- University, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ), Centers for Disease Control and Prevention, University of Iowa, Joint Commission on Accreditation of Healthcare Organizations
- Responsible party
- Principal investigator, Anthony Harris, University of Maryland, Baltimore
- Investigators
- Anthony D Harris, MD, MPH, Principal investigator, University of Maryland, Baltimore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01318213
- Sponsor's protocol ID
- HP-00047673
- Other IDs
- HHSA290200600015i
- Acronym
- BUGG
- Status last verified
- Aug 2019
- First submitted
- 16 Mar 2011
- Last updated
- 20 Aug 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Harris 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 24097234Morgan DJ, Dubberke ER, Hink T, Paszkiewicz G, Burnham CD, Pineles L, Magder L, Johnson JK, Leekha S, Harris AD. The Impact of Universal Glove and Gown Use on Clostridioides Difficile Acquisition: A Cluster-Randomized Trial. Clin Infect Dis. 2023 Feb 8;76(3):e1202-e1207. doi: 10.1093/cid/ciac519.
PubMed 35776131Harris AD, Morgan DJ, Pineles L, Magder L, O'Hara LM, Johnson JK. Acquisition of Antibiotic-Resistant Gram-negative Bacteria in the Benefits of Universal Glove and Gown (BUGG) Cluster Randomized Trial. Clin Infect Dis. 2021 Feb 1;72(3):431-437. doi: 10.1093/cid/ciaa071.
PubMed 31970393
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of the Use of Universal Glove and Gowning on Healthcare Associated Infection Rates and Antibiotic Resistant Bacteria
- ClinicalTrials.gov ID
- NCT01318213
- Acronym / sponsor ID
- BUGG / HP-00047673
- Keywords
- VRE, MRSA
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 19,856 participants (actual)
- Lead sponsor
- University of Maryland, BaltimoreUniversity, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ), Centers for Disease Control and Prevention, University of Iowa, Joint Commission on Accreditation of Healthcare Organizations
- Study start
- Dec 2010
- Primary completion
- 4 Oct 2012 (actual)
- Study completion
- 16 Oct 2013 (actual)
- First posted
- 18 Mar 2011 (estimated)
- 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.
This study will test if doctors, nurses and other people who take care of patients in hospitals wearing gloves and gown for all contact with patients in an intensive care unit (ICU) will:
- Decrease the chance of patients getting an infection while in the hospital
- Decrease the chance of patients picking up bacteria as a result of being in the hospital
- Decrease the time a patient spends in the ICU or in the hospital
- Increase the frequency of adverse events
The study will also look at whether making doctors, nurses and other people who take care of patients wear gloves and gown for all contact with patients will decrease the amount of time healthcare workers spend with patients.
This study will gather information by comparing what happens in ICUs that continue to do what they were doing before the study with what happens in ICUs that require healthcare workers to wear gloves and gown for all contact with patients.
This study will provide information that will help to make being in the hospital safer for all patients.
Detailed description
GOAL:
The overall goal of this project is to determine the effectiveness of universal glove and gowning procedures in reducing healthcare-associated infection (HAI) rates and acquisition of antibiotic-resistant bacteria in the Intensive Care Unit (ICU). More specifically, this project requires that a cluster-randomized trial (CRT) be designed and conducted to compare the effects of universal glove and gowning procedures as compared to the current standard of care in ICUs.
STUDY DESIGN: The study is a two arm, cluster-randomized trial. Randomization and analysis will be performed at the ICU level. A secondary statistical analysis will be performed at the patient level.
STUDY POPULATION: Adult patients in medical, surgical or combined medical/surgical ICUs.
SAMPLE SIZE: Based on the power calculations presented in Appendix I for each of the CRT aims, the study will use at least 18 ICU sites, half for the universal gown and glove intervention and half for CDC standards of care only. We will seek to maximize the number of ICUs involved to improve the scientific value of the study. The study is presently powered for a 1-year intervention study if 18 ICUs are included. After the 2 month pre-randomization period, we will use the actual number of sites enrolled and our baseline estimates to see if we can achieve the same degree of power for a study intervention of less than a year.
We have been able to recruit and retain 20 ICU sites. Upon completion of the pre-randomization period and based upon revised power calculations we will complete a 9-month intervention.
RANDOMIZATION: Randomization with pair matching based on the baseline data collection of outcomes will be used.
DATA ANALYSIS: Analyses of all aims will be performed according to the intention-to-treat (ITT) paradigm at the ICU level and will accommodate the matched-pairs design.
INTERVENTION:
Aim 1: Perform a CRT in which healthcare workers in the intervention ICUs will wear gloves and gowns for all patient contact while the control units perform regular standard and contact precautions per CDC guidelines in their respective ICUs.
Aim 1a: Measure the colonization acquisition rates of antibiotic-resistant pathogens in both intervention and non-intervention ICUs.
Aim 1b: Measure the HAI rates of catheter-associated bloodstream infection, catheter-associated urinary tract infection and ventilator-associated pneumonia in both intervention and non-intervention ICUs.
Aim 1c: Measure in-hospital 30-day mortality in both intervention and non-intervention ICUs.
Aim 1d: Measure hospital length of stay in both intervention and non-intervention ICUs.
Aim 1e: Measure the frequency of adverse events including frequency of healthcare worker visits and frequency of adverse events using an IHI adverse event tool.
Aim 1f: Statistically determine whether the intervention was effective in decreasing acquisition of antibiotic-resistant bacteria (primary outcome), reducing HAI rates (secondary outcome), decreasing in-hospital 30-day mortality (secondary outcome), decreasing length of stay (secondary outcome) and not increasing adverse events (secondary outcome).
HYPOTHESES:
Hypothesis 1a: Healthcare workers wearing gloves and gowns during all patient contact in the ICU setting will reduce antibiotic-resistant pathogen acquisition in at-risk patients.
Hypothesis 1b: Healthcare workers wearing gloves and gowns during all patient contact in the ICU setting will decrease HAI rates.
Hypothesis 1c: Healthcare workers wearing gloves and gowns during all patient contact in the ICU setting will decrease 30-day mortality.
Hypothesis 1d: Healthcare workers wearing gloves and gowns during all patient contact in the ICU setting will decrease hospital length of stay.
Hypothesis 1e: Healthcare workers wearing gloves and gowns during all patient contact in the ICU setting will not lead to an increase of adverse events.
CRITERIA FOR EVALUATION:
Primary Outcome:
The primary outcome of interest is the acquisition of an antibiotic-resistant pathogen, specifically Vancomycin-resistant Enterococcus (VRE) or Methicillin Resistant Staphylococcus Aureus(MRSA), as determined by peri-anal surveillance cultures for VRE and by nasal surveillance cultures for MRSA. The outcomes will be analyzed both individually and collectively (i.e., VRE, MRSA and VRE or MRSA).
Acquisition will be defined as:
- A patient who has an initial ICU surveillance culture that is negative for an antibiotic-resistant pathogen and
- Any subsequent surveillance culture within the same ICU admission that is positive for an antibiotic-resistant pathogen.
Secondary Outcomes:
The HAI rates to be measured will consist of catheter-associated bloodstream infection, catheter-associated urinary tract infection and ventilator-associated pneumonia rates. Hospital length of stay and 30-day mortality will also be measured as secondary outcomes. Adverse events are also a secondary outcome and will be measured using the frequency of healthcare worker visits and the frequency of adverse events as measured by an IHI tool.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Arm | – | –The intervention will consist of wearing gloves and gowns for all patient contact in the ICUs that are randomized to receive the intervention. During the intervention phases of the study, all healthcare workers (nurses, physicians, nurse extenders, respiratory therapists, social workers etc.) in the intervention group will be required to wear gloves and gowns for patient contact and when entering any patient room. In essence, healthcare workers will apply the CDC Contact Precautions guidelines for ALL patients. |
| Non-intervention - Usual Standard of Care | – | –The non-intervention units will follow their present standard of care. For all of these units, this will consist of healthcare workers following Contact Precautions (gloves and gowns) only for patients known to have antibiotic-resistant bacteria such as VRE and MRSA based on previous admission clinical and surveillance cultures or clinical cultures from the present admission. This represents on average 20-25% of patients on Contact Precautions. For the rest of the patients standard precautions will be followed. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients in medical, surgical or combined medical/surgical ICUs.
Key inclusion criteria (9 listed)
- ICUs to be included are: adult medical, surgical or combined medical surgical ICU as defined below:
- Medical ICU (MICU) > 80% of patients have a medical condition and have not undergone a surgical procedure during the current hospital stay
- Surgical ICU (SICU) > 80% of the patients have undergone a surgical procedure during the current hospital stay
- Combined Medical/Surgical ICU (MICU/SICU) - a roughly equivalent mixture of patients with medical conditions who have not undergone surgical procedures and patients who have undergone surgical procedures during the current hospital stay. Each group makes up > 20% and less than 80% of the total number of patients
Key exclusion criteria (1 listed)
- Pediatric ICUs and other non-medical or non-surgical ICUs will be excluded
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of ICU Patients Who Acquire VRE or MRSA
Time frame: 9 months
The outcome of interest is the acquisition of VRE or MRSA as determined by peri-anal surveillance cultures for VRE and by nasal surveillance cultures for MRSA. The outcomes will be analyzed both individually and collectively. Acquisition will be defined as: 1. A patient who has an initial ICU surveillance culture that is negative for an antibiotic-resistant pathogen. 2. Subsequent discharge surveillance culture within the same ICU admission that is positive for an antibiotic-resistant pathogen.
6 secondary outcomes
Number of ICU Patients Who Acquire CABSI
Time frame: 9 months
Number of ICU Patients Who Acquire CAUTI
Time frame: 9 months
Number of ICU Patients Who Acquire VAP
Time frame: 9 months
Changes from Baseline in 30-day Mortality Rate
Time frame: 9 months
Changes from Baseline in ICU LOS
Time frame: 9 months
Number of Adverse Events Occuring in the ICU
Time frame: 9 months
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 20 Aug 2019.
- Results publication: 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.
- Derived from this study: PubMed 35776131Morgan DJ, Dubberke ER, Hink T, Paszkiewicz G, Burnham CD, Pineles L, Magder L, Johnson JK, Leekha S, Harris AD. The Impact of Universal Glove and Gown Use on Clostridioides Difficile Acquisition: A Cluster-Randomized Trial. Clin Infect Dis. 2023 Feb 8;76(3):e1202-e1207. doi: 10.1093/cid/ciac519.
- Derived from this study: PubMed 31970393Harris AD, Morgan DJ, Pineles L, Magder L, O'Hara LM, Johnson JK. Acquisition of Antibiotic-Resistant Gram-negative Bacteria in the Benefits of Universal Glove and Gown (BUGG) Cluster Randomized Trial. Clin Infect Dis. 2021 Feb 1;72(3):431-437. doi: 10.1093/cid/ciaa071.
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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.
Anthony D Harris, MD, MPH principal investigator
University of Maryland, Baltimore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of MRSA and VRE, run by University of Maryland, Baltimore 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 9 inclusion and 1 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 20 Aug 2019. 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?
Number of ICU Patients Who Acquire VRE or MRSA (time frame: 9 months). 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 NCT01318213, which also lists 3 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 20 Aug 2019.