Nasal Colonization With Staph AureusNCT02045329
Impact of Mupirocin Decolonization on the Nasal Microbiome
An observational study of Nasal Colonization With Staph Aureus, run by VA Eastern Colorado Health Care System at 1 site in United States.
Trial summary
The normal bacteria that inhabit the human nose, also known as the nasal microbiome, may serve as a host defense mechanism against colonization and infection by Staphylococcus aureus, including methicillin resistant S. aureus (MRSA). Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Nasal Colonization With Staph Aureus
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2013to 5 Jun 2015
- 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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who are treated with mupirocin to clear nasal colonization with Staphylococcus aureus
Who may be able to join
None listed.
Who cannot join
- Age < 18 years Pregnant women Prisoners Decisionally challenged subjects
Trial locations and contacts
1 site in 1 country.
United States1 site
Veterans Affairs Eastern Colorado Healthcare System
Denver, Colorado, 80220
About this study
The normal bacteria that inhabit the human nose, also known as the nasal microbiome, may serve as a host defense mechanism against colonization and infection by Staphylococcus aureus, including methicillin resistant S. aureus (MRSA). Mupirocin is a topical antibacterial agent that may be used to clear nasal colonization with S. aureus, and reduce risk of S. aureus infection. The impact of mupirocin on the normal nasal microbiome is not known. We hypothesize that the nasal microbiome is changed by mupirocin. Our study aims to define the nasal microbiome before and after decolonization therapy with mupirocin.
Read the detailed description
- Outcome Measures: This is essentially a descriptive study. We will define the nasal microbiota before and after decolonization therapy with mupirocin.
- Description of Population to be Enrolled: Patients at VA-Denver who are starting a course of nasal mupirocin therapy for S. aureus decolonization will be enrolled. The common indications for decolonization therapy are preparation for joint replacement surgery and to facilitate removing patient from isolation for a prolonged stay on the rehabilitation service. Written informed consent will be obtained.
- Study design and research methods: A nasal swab will be obtained just prior to initiation of mupirocin therapy, within 48 hours of the completion of mupirocin therapy, one week, two weeks, four weeks, eight weeks, and 16 weeks following the completion of mupirocin therapy. The swab will be inserted into one nare and rotated for 3 seconds. The procedure will be repeated on the other nare. The two heads will be refrigerated immediately, and held at 2-5o C until they can be placed into sterile micro tubes for storage at -80o C. A separate swab will be passed through the mouth and rubbed over the tonsils and posterior oropharynx , and stored in the same fashion.
Broad-Range PCR and High throughput DNA Sequencing PCR amplification and sequencing of rRNA genes will follow our previously published protocol (13). In brief, DNA lysates are subjected to PCR with pan-bacterial 16S rDNA rDNA primers, which yields libraries of PCR amplicons representative of all bacteria or fungi in a specimen (14). Triplicate PCR reactions will be performed and amplicons pooled for each sample. Poisoning controls spiked with bacterial (e.g. Bacillus subtilis) genomic DNA will be assayed to detect the presence of PCR inhibitors in template DNA preparations; although not typically a problem with nasal swabs, inhibitory samples will be purified by ethanol precipitation and then resubmitted for PCR. PCR amplicon libraries will be sequenced using the high-throughput Illumina MiSeq personal sequencing platform. which is available through the University of Colorado's Division of Infectious Diseases. This platform can generate 5-20x106 DNA sequences in a single instrument run with mean read lengths ~450 nts. The primers used for broad-range PCR include unique barcoded sequences in order to simultaneously sequence multiple amplicon libraries in a single instrument run (15). We will construct and sequence libraries from 100 specimens (50 persistent MRSA carriers [cases] and 50 non-carriers [controls]) to a depth of >50,000 high-quality sequencing reads per specimen. Our preliminary study indicates that this depth of coverage will represent a complete survey of the nares microbiota for each specimen.
Sequence Analysis Microbes present in specimens will be identified through use of the Naïve Bayesian Classifier Tool (16) of the Ribosomal Database Project (17). To reduce the overall complexity of the datasets, similar rDNA sequences will be clustered into operational taxonomic units (OTUs) by clustering sequences based on taxonomic assignments. Data matrices are then assembled that tabulate the frequency of each OTU in a sample. Sampling coverage for each amplicon library will be estimated (18-20) and additional sequences screened if coverage is less than 95%. All sequences will be deposited into GenBank for public use.
Validation of candidate microorganisms Microbes identified through broad-range rDNA analysis as potentially impacting S. aureus colonization will be further evaluated based on targeted QPCR measurements. Based on our preliminary results and previously published studies that suggest their interference with S. aureus growth, both S. epidermidis, (femA) and Corynebacterium spp., (rpoB PCR) will be enumerated by Q-PCR (Table, below). Primer sets for Q-PCR assays of novel microbial groups will be designed for detection of rDNA operons (i.e. 16S-ITS-23S genes) through the ARB software package (21). In the case of previously recognized microbial groups and/or species, PCR primer sets may be identified by literature search.
- Conditions
- Nasal Colonization With Staph Aureus
- Keywords
- Staphylococcus aureus, mupirocin, decolonization
- Medical subject headings
- Staphylococcal Infections
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 |
|---|---|---|
| Staphylococcus aureus nasal carriers | Patients who are treated with mupirocin to clear nasal colonization with Staphylococcus aureus |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nasal microbiome changes with mupirocin
This is a descriptive study. We will define the nasal microbiota before and after decolonization therapy with mupirocin.
Measured: 16 weeks
Secondary outcomes (1)
Recurrence of S. aureus colonization
We will look at differences in the nasal microbiome of subjects who realpse with colonization and those who remain free of S. aureus colonization.
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2014 (estimated)
- Study startOct 2013
- Primary completion5 Jun 2015
- Study completion5 Jun 2015
Why it stopped: Logistically unable to recruit subjects
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Nasal Colonization With Staph AureusStudies of the same condition, open and under way.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Eastern Colorado Health Care System
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Mary T Bessesen, MD, Principal investigator, Veterans Affairs Eastern Colorado Healthcare System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02045329
- Sponsor's protocol ID
- COMIRB 13-1513
- Other IDs
- Grant funding
- Status last verified
- May 2018
- First submitted
- 22 Jan 2014
- Last updated
- 17 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Frank DN, Feazel LM, Bessesen MT, Price CS, Janoff EN, Pace NR. The human nasal microbiota and Staphylococcus aureus carriage. PLoS One. 2010 May 17;5(5):e10598. doi: 10.1371/journal.pone.0010598.
PubMed 20498722
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Mupirocin Decolonization on the Nasal Microbiome
- ClinicalTrials.gov ID
- NCT02045329
- Acronym / sponsor ID
- COMIRB 13-1513
- Conditions
- Nasal Colonization With Staph Aureus
- Keywords
- Staphylococcus aureus, mupirocin, decolonization
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Logistically unable to recruit subjects
- Enrolment
- 1 participants (actual)
- Lead sponsor
- VA Eastern Colorado Health Care SystemUS federal agency
- Study start
- Oct 2013
- Primary completion
- 5 Jun 2015 (actual)
- Study completion
- 5 Jun 2015 (actual)
- First posted
- 24 Jan 2014 (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.
The normal bacteria that inhabit the human nose, also known as the nasal microbiome, may serve as a host defense mechanism against colonization and infection by Staphylococcus aureus, including methicillin resistant S. aureus (MRSA). Mupirocin is a topical antibacterial agent that may be used to clear nasal colonization with S. aureus, and reduce risk of S. aureus infection. The impact of mupirocin on the normal nasal microbiome is not known. We hypothesize that the nasal microbiome is changed by mupirocin. Our study aims to define the nasal microbiome before and after decolonization therapy with mupirocin.
Detailed description
- Outcome Measures: This is essentially a descriptive study. We will define the nasal microbiota before and after decolonization therapy with mupirocin.
- Description of Population to be Enrolled: Patients at VA-Denver who are starting a course of nasal mupirocin therapy for S. aureus decolonization will be enrolled. The common indications for decolonization therapy are preparation for joint replacement surgery and to facilitate removing patient from isolation for a prolonged stay on the rehabilitation service. Written informed consent will be obtained.
- Study design and research methods: A nasal swab will be obtained just prior to initiation of mupirocin therapy, within 48 hours of the completion of mupirocin therapy, one week, two weeks, four weeks, eight weeks, and 16 weeks following the completion of mupirocin therapy. The swab will be inserted into one nare and rotated for 3 seconds. The procedure will be repeated on the other nare. The two heads will be refrigerated immediately, and held at 2-5o C until they can be placed into sterile micro tubes for storage at -80o C. A separate swab will be passed through the mouth and rubbed over the tonsils and posterior oropharynx , and stored in the same fashion.
Broad-Range PCR and High throughput DNA Sequencing PCR amplification and sequencing of rRNA genes will follow our previously published protocol (13). In brief, DNA lysates are subjected to PCR with pan-bacterial 16S rDNA rDNA primers, which yields libraries of PCR amplicons representative of all bacteria or fungi in a specimen (14). Triplicate PCR reactions will be performed and amplicons pooled for each sample. Poisoning controls spiked with bacterial (e.g. Bacillus subtilis) genomic DNA will be assayed to detect the presence of PCR inhibitors in template DNA preparations; although not typically a problem with nasal swabs, inhibitory samples will be purified by ethanol precipitation and then resubmitted for PCR. PCR amplicon libraries will be sequenced using the high-throughput Illumina MiSeq personal sequencing platform. which is available through the University of Colorado's Division of Infectious Diseases. This platform can generate 5-20x106 DNA sequences in a single instrument run with mean read lengths ~450 nts. The primers used for broad-range PCR include unique barcoded sequences in order to simultaneously sequence multiple amplicon libraries in a single instrument run (15). We will construct and sequence libraries from 100 specimens (50 persistent MRSA carriers [cases] and 50 non-carriers [controls]) to a depth of >50,000 high-quality sequencing reads per specimen. Our preliminary study indicates that this depth of coverage will represent a complete survey of the nares microbiota for each specimen.
Sequence Analysis Microbes present in specimens will be identified through use of the Naïve Bayesian Classifier Tool (16) of the Ribosomal Database Project (17). To reduce the overall complexity of the datasets, similar rDNA sequences will be clustered into operational taxonomic units (OTUs) by clustering sequences based on taxonomic assignments. Data matrices are then assembled that tabulate the frequency of each OTU in a sample. Sampling coverage for each amplicon library will be estimated (18-20) and additional sequences screened if coverage is less than 95%. All sequences will be deposited into GenBank for public use.
Validation of candidate microorganisms Microbes identified through broad-range rDNA analysis as potentially impacting S. aureus colonization will be further evaluated based on targeted QPCR measurements. Based on our preliminary results and previously published studies that suggest their interference with S. aureus growth, both S. epidermidis, (femA) and Corynebacterium spp., (rpoB PCR) will be enumerated by Q-PCR (Table, below). Primer sets for Q-PCR assays of novel microbial groups will be designed for detection of rDNA operons (i.e. 16S-ITS-23S genes) through the ARB software package (21). In the case of previously recognized microbial groups and/or species, PCR primer sets may be identified by literature search.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Staphylococcus aureus nasal carriers | – | –Patients who are treated with mupirocin to clear nasal colonization with Staphylococcus aureus |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who are treated with mupirocin to clear nasal colonization with Staphylococcus aureus
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- Age < 18 years Pregnant women Prisoners Decisionally challenged subjects
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
Nasal microbiome changes with mupirocin
Time frame: 16 weeks
This is a descriptive study. We will define the nasal microbiota before and after decolonization therapy with mupirocin.
1 secondary outcome
Recurrence of S. aureus colonization
Time frame: 16 weeks
Results and safety
The study was stopped early (reason given: Logistically unable to recruit subjects). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2018.
- Background: PubMed 20498722Frank DN, Feazel LM, Bessesen MT, Price CS, Janoff EN, Pace NR. The human nasal microbiota and Staphylococcus aureus carriage. PLoS One. 2010 May 17;5(5):e10598. doi: 10.1371/journal.pone.0010598.
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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 T Bessesen, MD principal investigator
Veterans Affairs Eastern Colorado Healthcare System
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 Nasal Colonization With Staph Aureus, run by VA Eastern Colorado Health Care System 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 0 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: stopped early, as of the sponsor's last update on 17 Oct 2018. 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 was stopped early (reason given: Logistically unable to recruit subjects). Results are not available in the source record.
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?
Nasal microbiome changes with mupirocin (time frame: 16 weeks). 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 NCT02045329, which also lists 1 linked publication.
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 17 Oct 2018.