Clostridium DifficileGLORINCT04036058
Effect of Expanding (Gloving) Barrier Precautions for Reducing Clostridium Difficile Acquisition (and Infection) in VA
A study testing Universal gloving in people with Clostridium Difficile, run by VA Office of Research and Development at 6 sites in United States.
Trial summary
Clostridium difficile (C. difficile) is a major pathogen causing serious healthcare-associated diarrheal illness in patients. Prevention of healthcare facility-onset C. difficile infection (CDI) is essential. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Clostridium Difficile
- What is being tested?
- Universal gloving
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 780 participants
- Where
- 6 sitesUnited States
- Study dates
- 29 Mar 2022to 30 Sep 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- VA inpatient units meeting the following criteria are eligible to participate in the study:
- Ability to identify one of the following inpatient units as defined by Centers for Disease Control (CDC) National Healthcare Safety Network30 by reviewing prior 12-month patient mix data (at least 80% of patients meet patient type):
- Adult Acute Medical Ward: Hospital area for the evaluation and treatment of patients with medical conditions or disorders.
- Adult Acute Medical/Surgical Ward: Hospital area for the evaluation of patients with medical and/or surgical conditions.
- Adult Acute Surgical Ward: Hospital area for evaluation and treatment of patients who have undergone a surgical procedure.
- Ability to collect and upload data (HAIs, mortality, length of stay, hand hygiene and barrier precaution compliance; glove use and glove plus gown use for contact precautions) required for analysis.
Show all 12Show fewer
- Local R\&D Committee approval.
- Letter of support from the Hospital Director or Chief of Staff.
- Ability to enroll one unit to intervention and one unit to control.
- To participate in interviews or focus groups, the individual must be:
- 18 years of age or older
- A patient admitted to the participating unit OR a healthcare worker who has regular work duties on the participating unit.
Who cannot join
- Intensive care units
- Long term care units
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Edward Hines Jr. VA Hospital, Hines, IL
Hines, Illinois, 60141-3030
William S. Middleton Memorial Veterans Hospital, Madison, WI
Madison, Wisconsin, 53705-2254
Clement J. Zablocki VA Medical Center, Milwaukee, WI
Milwaukee, Wisconsin, 53295-0001
VA Portland Health Care System, Portland, OR
Portland, Oregon, 97207-2964
James J. Peters VA Medical Center, Bronx, NY
The Bronx, New York, 10468-3904
Washington DC VA Medical Center, Washington, DC
Washington D.C., District of Columbia, 20422-0001
About this study
Official title: Effect of Expanding Barrier Precautions for Reducing Clostridium Difficile Acquisition in VA
Clostridium difficile (C. difficile) is a major pathogen causing serious healthcare-associated diarrheal illness in patients. Prevention of healthcare facility-onset C. difficile infection (CDI) is essential. Many CDI cases are caused by the transmission of the pathogen from patients who carry the bacteria, but do not have symptoms. However, there are limited data on how to prevent the transmission of C. difficile from patients who do not have symptoms. Universal gloving practices - the use of gloves by all healthcare workers for all patient contacts - may reduce CDI cases. In this study, the investigators will examine the effectiveness of universal gloving practices as compared to standard of care (use of gloving for contact only in patients with known CDI or other infections). The investigators will compare the effects of these practices on the transmission of C. difficile within participating hospital units to determine if universal gloving is an effective practice to prevent healthcare-associated CDI.
Read the detailed description
Background: Clostridium difficile infection (CDI) has become the most common healthcare-associated infection (HAI) in US hospitals, causing approximately 500,000 infections and 30,000 deaths per year. Prevention of healthcare-onset (HO) CDI has quickly become a priority for many hospitals. Hospital prevention measures are limited to modifiable risk factors (i.e., prudent antibiotic use and limiting exposure to C. difficile). Hospital exposure to C. difficile can occur directly (i.e., hands or clothing of healthcare workers) or indirectly (i.e., environmental surfaces or shared equipment), so infection prevention measures focus on healthcare worker hand hygiene, barrier precautions (use of gowns and gloves) and cleaning of the hospital environment and reusable medical equipment. However, these interventions are limited to symptomatic patients who test positive for CDI. Asymptomatic patients serve as a reservoir for cross-contamination, but microbiological screening for asymptomatic carriage of C. difficile is not routinely performed in healthcare. Gloving for all patient contacts may interrupt transmission from asymptomatic patients colonized with C. difficile.
Objectives: The overall purpose of the study is to determine the effectiveness of healthcare worker use of gloves for all patient contact (universal gloving) on reducing acquisition of C. difficile and hospital-onset CDI in inpatient hospital units. The main objective of the study is to compare the effects of universal gloving for all patient contact to the current standard of care (i.e., glove and gown use only for known CDI cases). The specific aims are: 1) compare the effects of universal gloving for all patient contact to the current standard of care on C. difficile acquisition rates in hospitalized patients; 2) compare the effects of universal gloving compared to standard of care on CDI rates, other HAI rates, 30-day mortality, and unit length of stay; and 3) evaluate intervention fidelity, cost, and stakeholder experiences with universal gloving.
Methods: The study will be a cluster randomized trial (CRT) in ten inpatient VA hospital units. Hospital units will be randomized either to implement universal gloving intervention or to continue standard of care. The universal gloving intervention will consist of all healthcare workers (nurses, providers, respiratory therapists, radiology and laboratory technicians, etc) utilizing gloves for all patient contacts in the units that are randomized to receive the intervention. The non-intervention units will follow standard of care which consists of healthcare workers using gowns and gloves only for patients with known CDI and other infections (e.g., MRSA). Unit-level data will be collected, including C. difficile acquisition and infection rates, mortality, length of stay, barrier precaution compliance, and end-user perceptions.
- Conditions
- Clostridium Difficile
- Being tested
- Universal gloving
- Keywords
- Clostridium difficile, Barrier Precautions, Personal Protective Equipment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Universal glovingOther
Also called Expanded barrier precautions
The intervention will consist of all healthcare workers (nurses, providers, respiratory therapists, radiology and laboratory technicians, etc) utilizing universal gloving (non-sterile gloves) for all patient contacts in the units that are randomized to receive the intervention. If a patient in the intervention unit is known to have CDI or a multidrug-resistant organisms, both gowns and gloves will be used as is currently recommended. Signage denoting what type of precautions are needed will be utilized.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Enact universal gloving practices Receives: Other: Universal gloving |
| Control | No intervention | Continue standard of care gloving practices |
What is being measured
The primary outcome is the main question the study is designed to answer.
C. Difficile Acquisition Rates
Acquisition will be defined as a patient who has an initial stool culture upon unit admission that is negative for C. difficile and the patient's subsequent discharge culture within the same unit that is positive for C. difficile. Acquisition rate will be (# of acquisitions/patient days)
Measured: during hospitalization, approximately 5 days
Secondary outcomes (10)
Hospital-onset C. Difficile Infection (HO-CDI) Rates
The development of CDI as determined by the presence of clinical symptoms and positive laboratory results. Infection rates will be measured on the unit level. Infection rate will be (# of CDI/patient days)
Measured: monthly, up to 18 months
MRSA (HAI) Rates
The rates of healthcare-associated methicillin-resistant Staphylococcus aureus (MRSA) infection will be measured as (# of MRSA cases/patient days) on the unit level.
Measured: monthly, up to 18 months
CLABSI (HAI) Rates
The rates of healthcare-associated central line-associated bloodstream infection (CLABSI) will be measured as (# of CLABSI cases per number of device days) on the unit level.
Measured: monthly, up to 18 months
CAUTI (HAI) Rates
The rates of healthcare-associated catheter-associated urinary tract infection (CAUTI) will be measured as (# of CAUTI cases per number of device days) on the unit level.
Measured: monthly, up to 18 months
Intervention Fidelity - Barrier Precaution Compliance
Healthcare worker barrier precaution compliance with unit-wide gloving practices during patient care activities will be measured via observations in participating units. Compliance will be measured as a percentage of use of appropriate gloving practices per opportunities for gloving practices.
Measured: monthly, up to 18 months
30-day Mortality
Mortality will be defined as the number of patients who die per the number of patient days at risk during study period. Mortality rate will be (# of deaths/patient days)
Measured: during hospitalization, up to one month
Length of Stay
the average number of days spent in the participating unit based on unit admission and unit discharge dates
Measured: during hospitalization, approximately 5 days
HAI Costs
total costs in U.S. dollars attributed to the number of HAIs during study period
Measured: through study completion, an average of 18 months
Supply Costs
total costs in U.S. dollars attributed to the number of gloves used during study period
Measured: through study completion, an average of 18 months
Patient and Healthcare Worker Experience
Qualitative data describing the patient and healthcare worker experience with the intervention of universal gloving.
Measured: months 12 - 18
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2019
- Study start29 Mar 2022
- Primary completion29 Dec 2023
- Study completion30 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Clostridium DifficileStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two-arm parallel assignment: the 10 participating units will be randomized; at each site, one unit will be randomized to the intervention group and one unit to the control group so that 5 units will enact the universal gloving intervention and 5 units will continue standard of care gloving practices.
- Masking
- None (open label)
- Enrolment
- 780 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Collaborators
- University of Wisconsin, Madison
- Responsible party
- Sponsor
- Investigators
- Nasia Safdar, MD PhD, Principal investigator, William S. Middleton Memorial Veterans Hospital, Madison, WI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04036058
- Sponsor's protocol ID
- IIR 18-087
- Acronym
- GLORI
- Status last verified
- Jun 2025
- First submitted
- 24 Jul 2019
- Last updated
- 11 Jul 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Expanding Barrier Precautions for Reducing Clostridium Difficile Acquisition in VA
- ClinicalTrials.gov ID
- NCT04036058
- Acronym / sponsor ID
- GLORI / IIR 18-087
- Conditions
- Clostridium Difficile
- Keywords
- Clostridium difficile, Barrier Precautions, Personal Protective Equipment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 780 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Collaborators
- University of Wisconsin, Madison
- Study start
- 29 Mar 2022 (actual)
- Primary completion
- 29 Dec 2023 (actual)
- Study completion
- 30 Sep 2024 (actual)
- First posted
- 29 Jul 2019 (actual)
- Results
- Posted 11 Jul 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Clostridium difficile (C. difficile) is a major pathogen causing serious healthcare-associated diarrheal illness in patients. Prevention of healthcare facility-onset C. difficile infection (CDI) is essential. Many CDI cases are caused by the transmission of the pathogen from patients who carry the bacteria, but do not have symptoms. However, there are limited data on how to prevent the transmission of C. difficile from patients who do not have symptoms. Universal gloving practices - the use of gloves by all healthcare workers for all patient contacts - may reduce CDI cases. In this study, the investigators will examine the effectiveness of universal gloving practices as compared to standard of care (use of gloving for contact only in patients with known CDI or other infections). The investigators will compare the effects of these practices on the transmission of C. difficile within participating hospital units to determine if universal gloving is an effective practice to prevent healthcare-associated CDI.
Detailed description
Background: Clostridium difficile infection (CDI) has become the most common healthcare-associated infection (HAI) in US hospitals, causing approximately 500,000 infections and 30,000 deaths per year. Prevention of healthcare-onset (HO) CDI has quickly become a priority for many hospitals. Hospital prevention measures are limited to modifiable risk factors (i.e., prudent antibiotic use and limiting exposure to C. difficile). Hospital exposure to C. difficile can occur directly (i.e., hands or clothing of healthcare workers) or indirectly (i.e., environmental surfaces or shared equipment), so infection prevention measures focus on healthcare worker hand hygiene, barrier precautions (use of gowns and gloves) and cleaning of the hospital environment and reusable medical equipment. However, these interventions are limited to symptomatic patients who test positive for CDI. Asymptomatic patients serve as a reservoir for cross-contamination, but microbiological screening for asymptomatic carriage of C. difficile is not routinely performed in healthcare. Gloving for all patient contacts may interrupt transmission from asymptomatic patients colonized with C. difficile.
Objectives: The overall purpose of the study is to determine the effectiveness of healthcare worker use of gloves for all patient contact (universal gloving) on reducing acquisition of C. difficile and hospital-onset CDI in inpatient hospital units. The main objective of the study is to compare the effects of universal gloving for all patient contact to the current standard of care (i.e., glove and gown use only for known CDI cases). The specific aims are: 1) compare the effects of universal gloving for all patient contact to the current standard of care on C. difficile acquisition rates in hospitalized patients; 2) compare the effects of universal gloving compared to standard of care on CDI rates, other HAI rates, 30-day mortality, and unit length of stay; and 3) evaluate intervention fidelity, cost, and stakeholder experiences with universal gloving.
Methods: The study will be a cluster randomized trial (CRT) in ten inpatient VA hospital units. Hospital units will be randomized either to implement universal gloving intervention or to continue standard of care. The universal gloving intervention will consist of all healthcare workers (nurses, providers, respiratory therapists, radiology and laboratory technicians, etc) utilizing gloves for all patient contacts in the units that are randomized to receive the intervention. The non-intervention units will follow standard of care which consists of healthcare workers using gowns and gloves only for patients with known CDI and other infections (e.g., MRSA). Unit-level data will be collected, including C. difficile acquisition and infection rates, mortality, length of stay, barrier precaution compliance, and end-user perceptions.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Two-arm parallel assignment: the 10 participating units will be randomized; at each site, one unit will be randomized to the intervention group and one unit to the control group so that 5 units will enact the universal gloving intervention and 5 units will continue standard of care gloving practices.
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: Universal glovingEnact universal gloving practices |
| Control | No intervention | –Continue standard of care gloving practices |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- VA inpatient units meeting the following criteria are eligible to participate in the study:
- Ability to identify one of the following inpatient units as defined by Centers for Disease Control (CDC) National Healthcare Safety Network30 by reviewing prior 12-month patient mix data (at least 80% of patients meet patient type):
- Ability to collect and upload data (HAIs, mortality, length of stay, hand hygiene and barrier precaution compliance; glove use and glove plus gown use for contact precautions) required for analysis.
- Local R\&D Committee approval.
- Letter of support from the Hospital Director or Chief of Staff.
Key exclusion criteria (2 listed)
- Intensive care units
- Long term care units
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 |
|---|---|---|
| Universal glovingAlso: Expanded barrier precautionsThe intervention will consist of all healthcare workers (nurses, providers, respiratory therapists, radiology and laboratory technicians, etc) utilizing universal gloving (non-sterile gloves) for all patient contacts in the units that are randomized to receive the intervention. If a patient in the intervention unit is known to have CDI or a multidrug-resistant organisms, both gowns and gloves will be used as is currently recommended. Signage denoting what type of precautions are needed will be utilized. | Other | Intervention |
Primary outcome
C. Difficile Acquisition Rates
Time frame: during hospitalization, approximately 5 days
Acquisition will be defined as a patient who has an initial stool culture upon unit admission that is negative for C. difficile and the patient's subsequent discharge culture within the same unit that is positive for C. difficile. Acquisition rate will be (# of acquisitions/patient days)
10 secondary outcomes
Hospital-onset C. Difficile Infection (HO-CDI) Rates
Time frame: monthly, up to 18 months
MRSA (HAI) Rates
Time frame: monthly, up to 18 months
CLABSI (HAI) Rates
Time frame: monthly, up to 18 months
CAUTI (HAI) Rates
Time frame: monthly, up to 18 months
Intervention Fidelity - Barrier Precaution Compliance
Time frame: monthly, up to 18 months
30-day Mortality
Time frame: during hospitalization, up to one month
Length of Stay
Time frame: during hospitalization, approximately 5 days
HAI Costs
Time frame: through study completion, an average of 18 months
Supply Costs
Time frame: through study completion, an average of 18 months
Patient and Healthcare Worker Experience
Time frame: months 12 - 18
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Nasia Safdar, MD PhD principal investigator
William S. Middleton Memorial Veterans Hospital, Madison, WI
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Universal gloving in people with Clostridium Difficile, run by VA Office of Research and Development at 6 sites 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 12 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 11 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites 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?
Yes. Results are posted in the registry (first posted 11 Jul 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
C. Difficile Acquisition Rates (time frame: during hospitalization, approximately 5 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Jul 2025.