Human MicrobiomePhase 4NCT04218799
Human Microbiome and Healthcare Associated Infections - Nursing Home Dwelling Older Veterans
A Phase 4 study testing Intranasal Mupirocin and Topical Chlorhexidine in people with Human Microbiome, run by University of Maryland, Baltimore at 2 sites in United States.
Trial summary
The purpose of the research is to find out the effect of commonly used topical antibiotics on the bacteria that live in the nose, throat and on the skin of older adults. In addition, the investigators want to determine if these topical antibiotics affect how bacteria are spread in Community Living Centers of the VA… Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Human Microbiome
- What is being tested?
- Intranasal Mupirocin and Topical Chlorhexidine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 2 sitesUnited States
- Study dates
- 12 Aug 2014to 22 Sep 2015
- Phase
- Phase 4
- 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 50 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 50 years or older.
- Living in a participating nursing home for at least 80% of the past 3 months-
- Willing to provide anterior nares, posterior pharynx, skin and throat specimens over the study period.
- Willing to use intranasal mupirocin and topical chlorhexidine over a five day period.
- Provide signed and dated informed consent from subject or LAR.
Who cannot join
- Recent history of MRSA colonization
- Use of mupirocin nasal ointment in past 3 months
- Use of topical chlorhexidine in past 3 months
- History of an allergic reaction to chlorhexidine or mupirocin
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Loch Raven VA Community Living Center
Baltimore, Maryland, 21218
Perry Point VA Community Living Center
Perry Point, Maryland, 21902
About this study
The purpose of the research is to find out the effect of commonly used topical antibiotics on the bacteria that live in the nose, throat and on the skin of older adults. In addition, the investigators want to determine if these topical antibiotics affect how bacteria are spread in Community Living Centers of the VA Maryland Health Care System.
- Conditions
- Human Microbiome
- Being tested
- Intranasal Mupirocin and Topical Chlorhexidine
- Keywords
- intranasal mupirocin, topical chlorhexidine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intranasal Mupirocin and Topical ChlorhexidineDrug
Antimicrobial antiseptic skin cleanser (4% chlorhexidine) for daily use on Day 1, 3 and 5 of Week 8 of the study. BACTROBAN NASAL ointment (mupirocin calcium ointment, 2%) for use intranasally twice-daily on Day 1, 2, 3, 4 and 5 of Week 8 of the study.
| Study group | Role | What they receive |
|---|---|---|
| Intranasal Mupirocin and Topical Chlorhexidine | Experimental | Not described Receives: Drug: Intranasal Mupirocin and Topical Chlorhexidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the Abundance of Staphylococcus Aureus in the Nose After Decolonization
Change in the abundance of Staphylococcus aureus in the nose from immediately before mupirocin administration to 8 weeks after mupirocin administration.
Measured: 8 weeks
Change in the Abundance of Staphylococcus Aureus in the Throat After Decolonization
Change in the abundance of Staphylococcus aureus in the throat from immediately before mupirocin administration to 8 weeks after mupirocin administration.
Measured: 8 weeks
Change in the Abundance of Gram Negative Bacteria on the Subclavian Skin After Decolonization
Quantitative PCR using 16s rRNA is used to quantify the total bacterial load of Gram negative bacteria on the subclavian skin before and after decolonization.
Measured: 12 months
Change in the Abundance of Gram Negative Bacteria on the Femoral Skin After Decolonization
Quantitative PCR using 16s rRNA is used to quantify the total bacterial load of Gram negative bacteria on the femoral skin before and after decolonization.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2020
- Study start12 Aug 2014
- Primary completion22 Sep 2015
- Study completion22 Sep 2015
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 Human MicrobiomeStudies 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 4
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Maryland, Baltimore
- Sponsor type
- University, hospital or other
- Collaborators
- VA Office of Research and Development
- Responsible party
- Principal investigator, Mary-Claire Roghmann, University of Maryland, Baltimore
- Investigators
- Mary-Claire Roghmann, MD, MS, Principal investigator, University of Maryland, Baltimore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04218799
- Sponsor's protocol ID
- HP-00058923
- Status last verified
- Jun 2023
- First submitted
- 20 Dec 2019
- Last updated
- 6 Jun 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Human Microbiome and Healthcare Associated Infections - Nursing Home Dwelling Older Veterans
- ClinicalTrials.gov ID
- NCT04218799
- Acronym / sponsor ID
- HP-00058923
- Conditions
- Human Microbiome
- Keywords
- intranasal mupirocin, topical chlorhexidine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- University of Maryland, BaltimoreUniversity, hospital or other
- Collaborators
- VA Office of Research and Development
- Study start
- 12 Aug 2014 (actual)
- Primary completion
- 22 Sep 2015 (actual)
- Study completion
- 22 Sep 2015 (actual)
- First posted
- 6 Jan 2020 (actual)
- Results
- Posted 24 Apr 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the research is to find out the effect of commonly used topical antibiotics on the bacteria that live in the nose, throat and on the skin of older adults. In addition, the investigators want to determine if these topical antibiotics affect how bacteria are spread in Community Living Centers of the VA Maryland Health Care System.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intranasal Mupirocin and Topical Chlorhexidine | Experimental | Drug: Intranasal Mupirocin and Topical Chlorhexidine |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 50 years or older.
- Living in a participating nursing home for at least 80% of the past 3 months-
- Willing to provide anterior nares, posterior pharynx, skin and throat specimens over the study period.
- Willing to use intranasal mupirocin and topical chlorhexidine over a five day period.
- Provide signed and dated informed consent from subject or LAR.
Key exclusion criteria (4 listed)
- Recent history of MRSA colonization
- Use of mupirocin nasal ointment in past 3 months
- Use of topical chlorhexidine in past 3 months
- History of an allergic reaction to chlorhexidine or mupirocin
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 |
|---|---|---|
| Intranasal Mupirocin and Topical ChlorhexidineAntimicrobial antiseptic skin cleanser (4% chlorhexidine) for daily use on Day 1, 3 and 5 of Week 8 of the study. BACTROBAN NASAL ointment (mupirocin calcium ointment, 2%) for use intranasally twice-daily on Day 1, 2, 3, 4 and 5 of Week 8 of the study. | Drug | Intranasal Mupirocin and Topical Chlorhexidine |
Primary outcome
Change in the Abundance of Staphylococcus Aureus in the Nose After Decolonization
Time frame: 8 weeks
Change in the abundance of Staphylococcus aureus in the nose from immediately before mupirocin administration to 8 weeks after mupirocin administration.
Change in the Abundance of Staphylococcus Aureus in the Throat After Decolonization
Time frame: 8 weeks
Change in the abundance of Staphylococcus aureus in the throat from immediately before mupirocin administration to 8 weeks after mupirocin administration.
Change in the Abundance of Gram Negative Bacteria on the Subclavian Skin After Decolonization
Time frame: 12 months
Quantitative PCR using 16s rRNA is used to quantify the total bacterial load of Gram negative bacteria on the subclavian skin before and after decolonization.
Change in the Abundance of Gram Negative Bacteria on the Femoral Skin After Decolonization
Time frame: 12 months
Quantitative PCR using 16s rRNA is used to quantify the total bacterial load of Gram negative bacteria on the femoral skin before and after decolonization.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2023.
- 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.
Mary-Claire Roghmann, MD, MS principal investigator
University of Maryland, Baltimore
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Intranasal Mupirocin and Topical Chlorhexidine in people with Human Microbiome, 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 5 inclusion and 4 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 6 Jun 2023. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Apr 2020). 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?
Change in the Abundance of Staphylococcus Aureus in the Nose After Decolonization (time frame: 8 weeks). The study lists 4 primary outcomes in all. 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 6 Jun 2023.