Staphylococcus AureusNCT03319368
Preventing the Spread of Infection in Nursing Homes
A study testing Targeted gown and glove use in people with Staphylococcus Aureus, run by University of Maryland, Baltimore at 2 sites in United States.
Trial summary
This study evaluates the feasibility of targeting more frequent gown and glove use for specific high risk moments of care in specific nursing home residents in order to prevent Staphylococcus aureus (SA) acquisition and infection. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Staphylococcus Aureus
- What is being tested?
- Targeted gown and glove use
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 367 participants
- Where
- 2 sitesUnited States
- Study dates
- 18 Dec 2017to 26 Jul 2018
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years
- Reside in a participating nursing home
Who cannot join
- Identified by nursing home staff as combative or with other behavioral problems which could lead to agitation if approached by project staff
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Lorien Riverside
Belcamp, Maryland, 21017
Lorien Mays Chapel
Lutherville-Timonium, Maryland, 21093
About this study
Official title: Implementation of a Novel Strategy to Prevent Staphylococcus Aureus (SA) Acquisition in Community-Based Nursing Homes to Prevent Invasive SA Infection - Feasibility and Pilot to Guide a Multicenter Stepped Wedge Cluster Trial
This study evaluates the feasibility of targeting more frequent gown and glove use for specific high risk moments of care in specific nursing home residents in order to prevent Staphylococcus aureus (SA) acquisition and infection.
Read the detailed description
Nursing homes are settings with a high rate of Staphylococcus aureus (SA) acquisition, which leads to infection, particularly for short stay residents. The current standard of care for preventing SA acquisition and SA infection in nursing homes is Standard Precautions (gowns and gloves for anticipated contact with blood, body fluids, skin breakdown or mucous membranes) for all residents.
The investigators propose a feasibility study of a novel strategy, the addition of targeted gown and glove use, to prevent SA acquisition and SA infection in residents of nursing homes. Rather than wearing gowns and gloves for all care activities to prevent transmission, gown and glove use can be targeted to specific high risk "moments" of care for specific high risk residents. High risk "moments" for gown and glove use are care activities most likely to transmit SA based on prior research. Residents with chronic wounds and medical devices are: 1) most likely to be colonized with SA; 2) most likely to acquire SA; 3) most likely to transmit SA to healthcare worker clothing and hands; and 4) most likely to develop a SA infection based on prior research and thus would be considered high risk residents.
The investigators will perform a quasi-experimental (before-after) study of this intervention, targeted gown and glove use, at two community-based nursing homes to demonstrate its feasibility and evaluate its effect on SA acquisition and SA infection rates.
- Conditions
- Staphylococcus Aureus
- Being tested
- Targeted gown and glove use
- Medical subject headings
- Staphylococcal Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Targeted gown and glove useOther
Gown and glove use for high risk care activities in high risk residents
| Study group | Role | What they receive |
|---|---|---|
| Intervention: Targeted gown and glove use | Experimental | Additional gowns and gloves used for high risk care activities Receives: Other: Targeted gown and glove use |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rates of Staphylococcus Aureus Acquisition: Percentage of Short Stay Participants Who Acquired MRSA or MSSA (or Both) During the Study Period
Rates of Staphylococcus aureus acquisition in the baseline and intervention periods: Participants were swabbed in the anterior nares and inguinal fold at nursing home admission (or start of study period) and again at discharge (or end of study period). This is the percentage of participants who acquired MRSA or MSSA (or both) during the study period.
Measured: 5 months: 2 months in the baseline period, one month to prep the intervention, then 2 months in the intervention period
Secondary outcomes (1)
Rates of Staphylococcus Aureus Transmission: Percentage of Short Stay Participants Who Acquired MRSA or MSSA (or Both) From MRSA/MSSA Transmission From Another Study Participant During the Study Period
Rates of Staphylococcus aureus transmission in the baseline and intervention periods: Participants were swabbed in the anterior nares and inguinal fold at nursing home admission (or start of study period) and again at discharge (or end of study period). The DNA sequences of each SA isolate from each acquisition were evaluated to see if there was a match to another epidemiologically linked (same floor, same study period) SA isolate. This is the percentage of participants who acquired MRSA or MSSA (or both) from MRSA/MSSA transmission from another study participant during the study period.
Measured: 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2017
- Study start18 Dec 2017
- Primary completion26 Jul 2018
- Study completion26 Jul 2018
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.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Staphylococcus AureusStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 367 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Maryland, Baltimore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mary-Claire Roghmann, University of Maryland, Baltimore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03319368
- Sponsor's protocol ID
- HP-00077879
- Status last verified
- Sep 2023
- First submitted
- 18 Oct 2017
- Last updated
- 21 Mar 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Roghmann MC, O'Hara LM, Mayoryk S, Robinson GL, Lydecker AD, French I, Paszkiewicz G, Johnson JK. Improving infection control in nursing homes: Enhanced barrier precautions and multidrug-resistant organism colonization. Am J Infect Control. 2026 Jun 18:S0196-6553(26)00553-5. doi: 10.1016/j.ajic.2026.06.013. Online ahead of print.
PubMed 42314874Lydecker AD, Osei PA, Pineles L, Johnson JK, Meisel J, Stine OC, Magder L, Gurses AP, Hebden J, Oruc C, Mody L, Jacobs Slifka K, Stone ND, Roghmann MC. Targeted gown and glove use to prevent Staphylococcus aureus acquisition in community-based nursing homes: A pilot study. Infect Control Hosp Epidemiol. 2021 Apr;42(4):448-454. doi: 10.1017/ice.2020.1219. Epub 2020 Oct 20.
PubMed 33077004
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation of a Novel Strategy to Prevent Staphylococcus Aureus (SA) Acquisition in Community-Based Nursing Homes to Prevent Invasive SA Infection - Feasibility and Pilot to Guide a Multicenter Stepped Wedge Cluster Trial
- ClinicalTrials.gov ID
- NCT03319368
- Acronym / sponsor ID
- HP-00077879
- Conditions
- Staphylococcus Aureus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 367 participants (actual)
- Lead sponsor
- University of Maryland, BaltimoreUniversity, hospital or other
- Study start
- 18 Dec 2017 (actual)
- Primary completion
- 26 Jul 2018 (actual)
- Study completion
- 26 Jul 2018 (actual)
- First posted
- 24 Oct 2017 (actual)
- Results
- Posted 21 Mar 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study evaluates the feasibility of targeting more frequent gown and glove use for specific high risk moments of care in specific nursing home residents in order to prevent Staphylococcus aureus (SA) acquisition and infection.
Detailed description
Nursing homes are settings with a high rate of Staphylococcus aureus (SA) acquisition, which leads to infection, particularly for short stay residents. The current standard of care for preventing SA acquisition and SA infection in nursing homes is Standard Precautions (gowns and gloves for anticipated contact with blood, body fluids, skin breakdown or mucous membranes) for all residents.
The investigators propose a feasibility study of a novel strategy, the addition of targeted gown and glove use, to prevent SA acquisition and SA infection in residents of nursing homes. Rather than wearing gowns and gloves for all care activities to prevent transmission, gown and glove use can be targeted to specific high risk "moments" of care for specific high risk residents. High risk "moments" for gown and glove use are care activities most likely to transmit SA based on prior research. Residents with chronic wounds and medical devices are: 1) most likely to be colonized with SA; 2) most likely to acquire SA; 3) most likely to transmit SA to healthcare worker clothing and hands; and 4) most likely to develop a SA infection based on prior research and thus would be considered high risk residents.
The investigators will perform a quasi-experimental (before-after) study of this intervention, targeted gown and glove use, at two community-based nursing homes to demonstrate its feasibility and evaluate its effect on SA acquisition and SA infection rates.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention: Targeted gown and glove use | Experimental | Other: Targeted gown and glove useAdditional gowns and gloves used for high risk care activities |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age ≥18 years
- Reside in a participating nursing home
Key exclusion criteria (1 listed)
- Identified by nursing home staff as combative or with other behavioral problems which could lead to agitation if approached by project staff
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 |
|---|---|---|
| Targeted gown and glove useGown and glove use for high risk care activities in high risk residents | Other | Intervention: Targeted gown and glove use |
Primary outcome
Rates of Staphylococcus Aureus Acquisition: Percentage of Short Stay Participants Who Acquired MRSA or MSSA (or Both) During the Study Period
Time frame: 5 months: 2 months in the baseline period, one month to prep the intervention, then 2 months in the intervention period
Rates of Staphylococcus aureus acquisition in the baseline and intervention periods: Participants were swabbed in the anterior nares and inguinal fold at nursing home admission (or start of study period) and again at discharge (or end of study period). This is the percentage of participants who acquired MRSA or MSSA (or both) during the study period.
1 secondary outcome
Rates of Staphylococcus Aureus Transmission: Percentage of Short Stay Participants Who Acquired MRSA or MSSA (or Both) From MRSA/MSSA Transmission From Another Study Participant During the Study Period
Time frame: 5 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 42314874Roghmann MC, O'Hara LM, Mayoryk S, Robinson GL, Lydecker AD, French I, Paszkiewicz G, Johnson JK. Improving infection control in nursing homes: Enhanced barrier precautions and multidrug-resistant organism colonization. Am J Infect Control. 2026 Jun 18:S0196-6553(26)00553-5. doi: 10.1016/j.ajic.2026.06.013. Online ahead of print.
- Derived from this study: PubMed 33077004Lydecker AD, Osei PA, Pineles L, Johnson JK, Meisel J, Stine OC, Magder L, Gurses AP, Hebden J, Oruc C, Mody L, Jacobs Slifka K, Stone ND, Roghmann MC. Targeted gown and glove use to prevent Staphylococcus aureus acquisition in community-based nursing homes: A pilot study. Infect Control Hosp Epidemiol. 2021 Apr;42(4):448-454. doi: 10.1017/ice.2020.1219. Epub 2020 Oct 20.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Targeted gown and glove use in people with Staphylococcus Aureus, run by University of Maryland, Baltimore at 2 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 2 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 21 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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 21 Mar 2024). 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?
Rates of Staphylococcus Aureus Acquisition: Percentage of Short Stay Participants Who Acquired MRSA or MSSA (or Both) During the Study Period (time frame: 5 months: 2 months in the baseline period, one month to prep the intervention, then 2 months in the intervention period). 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 NCT03319368, which also lists 2 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 21 Mar 2024.