Human MicrobiomePhase 4NCT04222699

Cultures Before and After Decolonization in Community Dwelling Adults With Current S. Aureus Colonization

A Phase 4 study testing Mupirocin calcium ointment, 2% and Topical Chlorhexidine, 4% in people with Human Microbiome, run by VA Office of Research and Development at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Human Microbiome
What is being tested?: Mupirocin calcium ointment, 2% and Topical Chlorhexidine, 4%
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 58 participants
Where: 1 siteUnited States
Study dates: 18 Sep 2012to 18 Nov 2014
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 18 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Veteran living in the greater Baltimore, MD area
Adults >= 18 years of age
Living independently
Willing and able to provide anterior nares, skin, throat, and perirectal specimens over an 18 week time period.
Willing and able to administer intranasal mupirocin and topical chlorhexidine over a five day period
Capable of understanding and complying with the entire study protocol.
Provided signed and dated informed consent

Who cannot join

Use of anticancer chemotherapy or radiation therapy (cytotoxic) within the past 6 months
History of HIV infection with most recent CD4 of <200
Immunosuppression medications within the past 3 months
Use of systemic antibacterial or antifungal agents in the past 3 months
Use of nasal steroids currently or in the past 3 months
Use of nasal antimicrobial ointment in the past 3 months

Show all 12Show fewer

Any current indwelling percutaneous medical device or urinary catheter
Acute care hospitalization in the past 3 months
Planned surgery or hospitalization during the study period
History of an allergic reaction to chlorhexidine or mupirocin
Oral temperature of >100 F at enrollment visit
BMI <18 or >35 at enrollment visit

Trial locations and contacts

1 site in 1 country.

United States1 site

Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
Baltimore, Maryland, 21201

Other trials in United States

About this study

The investigators propose to study the microbiome of the nose, throat and three skin sites in a population without current exposure to the healthcare environment: 80 community dwelling adults. We will characterize the microbial communities in these body sites (nose, throat, perirectal and three skin sites) over time using culture-independent techniques. The investigators will then "decolonize" the subjects. Subjects will receive intranasal mupirocin and topical chlorhexidine. The investigators will then compare the microbial communities at baseline and after decolonization within individuals. Our overall hypothesis is that the microbial composition of these sites and the response to decolonization is influenced by the healthcare environment and that decolonization leads to re-colonization with an increasing proportion of Gram-negative bacilli.

Conditions: Human Microbiome
Being tested: Mupirocin calcium ointment, 2%, Topical Chlorhexidine, 4%
Keywords: intranasal mupirocin, topical chlorhexidine

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Mupirocin calcium ointment, 2%Drug
Also called BACTROBAN NASAL ointment
Mupirocin nasal ointment is used to treat or prevent infections in the nose due to certain strains of Staphylococcus aureus bacteria. This medicine works by killing bacteria or preventing their growth.
Topical Chlorhexidine, 4%Drug
Chlorhexidine is an antiseptic that fights bacteria.
Topical chlorhexidine is used to clean the skin to prevent infection that may be caused by surgery, injection, or skin injury.

Study groups in NCT04222699
Study group	Role	What they receive
Intranasal Mupirocin and Topical Chlorhexidine	Experimental	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. Receives: Drug: Mupirocin calcium ointment, 2%; Drug: Topical Chlorhexidine, 4%

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.

18 Sep 201218 Nov 2014

First posted10 Jan 2020
Study start18 Sep 2012
Primary completion18 Nov 2014
Study completion18 Nov 2014

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 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 4
Primary purpose: Health services research
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 58 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04222699
Sponsor's protocol ID: INFB-018-01CX
Status last verified: Apr 2020
First submitted: 23 Dec 2019
Last updated: 14 Apr 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 14 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Cultures Before and After Decolonization in Community Dwelling Adults With Current S. Aureus Colonization
ClinicalTrials.gov ID: NCT04222699
Acronym / sponsor ID: INFB-018-01CX
Conditions: Human Microbiome
Keywords: intranasal mupirocin, topical chlorhexidine
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 58 participants (actual)
Lead sponsor: VA Office of Research and DevelopmentUS federal agency
Study start: 18 Sep 2012 (actual)
Primary completion: 18 Nov 2014 (actual)
Study completion: 18 Nov 2014 (actual)
First posted: 10 Jan 2020 (actual)
Results: Posted 14 Apr 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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: Mupirocin calcium ointment, 2%, Drug: Topical Chlorhexidine, 4%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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

Veteran living in the greater Baltimore, MD area
Adults >= 18 years of age
Living independently
Willing and able to provide anterior nares, skin, throat, and perirectal specimens over an 18 week time period.
Willing and able to administer intranasal mupirocin and topical chlorhexidine over a five day period

Key exclusion criteria (12 listed)

Use of anticancer chemotherapy or radiation therapy (cytotoxic) within the past 6 months
History of HIV infection with most recent CD4 of <200
Immunosuppression medications within the past 3 months
Use of systemic antibacterial or antifungal agents in the past 3 months
Use of nasal steroids currently or in the past 3 months

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
Mupirocin calcium ointment, 2%Also: BACTROBAN NASAL ointmentMupirocin nasal ointment is used to treat or prevent infections in the nose due to certain strains of Staphylococcus aureus bacteria. This medicine works by killing bacteria or preventing their growth.	Drug	Intranasal Mupirocin and Topical Chlorhexidine
Topical Chlorhexidine, 4%Chlorhexidine is an antiseptic that fights bacteria. Topical chlorhexidine is used to clean the skin to prevent infection that may be caused by surgery, injection, or skin injury.	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

Results posted to the registry on 14 Apr 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Intranasal Mupirocin and Topical Chlorhexidine	28	26

Primary outcome: Change in the Abundance of Staphylococcus Aureus in the Nose After Decolonization

Time frame: 8 weeks. Mean (Standard Deviation). Unit: fg/uL

Measure	Intranasal Mupirocin and Topical Chlorhexidine n = 25
Value	-781 (3681)

Population analysed: Out of the 28 participants assigned to this group, 2 were lost to follow-up and 1 had an insufficient amount of sample collected and could not be included in the analysis.

Primary outcome: Change in the Abundance of Staphylococcus Aureus in the Throat After Decolonization

Time frame: 8 weeks. Mean (Standard Deviation). Unit: fg/uL

Measure	Intranasal Mupirocin and Topical Chlorhexidine n = 25
Value	-321 (7053)

Population analysed: Out of the 28 participants assigned to this group, 2 were lost to follow-up and 1 had an insufficient amount of sample collected and could not be included in the analysis.

Primary outcome: Change in the Abundance of Gram Negative Bacteria on the Subclavian Skin After Decolonization

Time frame: 12 months

Population analysed: Subclavian skin samples deteriorated prior to sample analysis and cannot be used.

Primary outcome: Change in the Abundance of Gram Negative Bacteria on the Femoral Skin After Decolonization

Time frame: 12 months

Population analysed: Femoral skin samples deteriorated prior to sample analysis and cannot be used.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Intranasal Mupirocin and Topical Chlorhexidine	0 of 28 (0%)	0 of 28 (0%)	0 of 28

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2020.
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 principal investigator

Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Mupirocin calcium ointment, 2% and Topical Chlorhexidine, 4% in people with Human Microbiome, run by VA Office of Research and Development 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 7 inclusion and 12 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 Apr 2020. 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.

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 14 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?

On the ClinicalTrials.gov record for NCT04222699.

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 Apr 2020.