Nasal Carriers of Staphylococcus AureusNCT00997139
Clearance of Nasal Staphylococcus Aureus With Triple Antibiotic Ointment
A study testing Neosporin (polymyxin B 5,000units, bacitracin 400 units, neomycin 3.5mg) in people with Nasal Carriers of Staphylococcus Aureus, run by Northwestern University at 1 site in United States.
Trial summary
Staphylococcus aureus, a bacteria that lives commonly in the anterior nostrils, is seen in about 30% of healthcare workers. Applying mupirocin ointment, a prescription, to the nostrils twice daily for 5 days is the current standard of care for treatment to clear this bacteria. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Nasal Carriers of Staphylococcus Aureus
- What is being tested?
- Neosporin (polymyxin B 5,000units, bacitracin 400 units, neomycin 3.5mg)
- How many people
- 216 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2009to Nov 2010
- 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
- Willing and able to give informed consent
- Must have consented prior to registration for the study
Who cannot join
- active infection
- concurrent treatment with antibiotics, topical or systemic
- S. aureus decolonization attempt in prior six months
- history of HIV
- chemotherapy or systemic immunosuppressive therapy
- history of neomycin allergy or sensitivity
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clearance of Nasal Staphylococcus Aureus Colonization With Triple Antibiotic Ointment
Staphylococcus aureus, a bacteria that lives commonly in the anterior nostrils, is seen in about 30% of healthcare workers. Applying mupirocin ointment, a prescription, to the nostrils twice daily for 5 days is the current standard of care for treatment to clear this bacteria. This research study is designed to determine the rate of clearance of this bacteria in healthcare workers who are carriers when using triple antibiotic ointment instead of mupirocin ointment.
- Conditions
- Nasal Carriers of Staphylococcus Aureus
- Being tested
- Neosporin (polymyxin B 5,000units, bacitracin 400 units, neomycin 3.5mg)
- Keywords
- healthcare, staphylococcus aureus, nasal
- Medical subject headings
- Staphylococcal Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neosporin (polymyxin B 5,000units, bacitracin 400 units, neomycin 3.5mg)Drug
2 1/32oz packages will be dispensed. If positive nasal swab for S. aureus, subjects will apply a small amount to anterior nares twice daily for 5 days.
What is being measured
The primary outcome is the main question the study is designed to answer.
Carrier Rate for Staphylococcus Aureus
Percentage of subjects with baseline culture positive for Staphylococcus aureus (via nasal swab)
Measured: Baseline
MSSA Clearance Rate
Percentage of subjects with methicillin-sensitive S. aureus on Baseline culture who achieved clearance with treatment.
Measured: 14 days
MRSA Clearance Rate
Percentage of subjects with methicillin-resistant S. aureus on Baseline culture who achieved clearance with treatment.
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2009 (estimated)
- Study startSep 2009
- Primary completionNov 2010
- Study completionNov 2010
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 Nasal Carriers of Staphylococcus AureusStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 216 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dennis West, Northwestern University
- Investigators
- Peter Lio, MD, Principal investigator, Northwestern Unviersity
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00997139
- Sponsor's protocol ID
- NU-9892
- Status last verified
- Dec 2014
- First submitted
- 15 Oct 2009
- Last updated
- 5 Jan 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clearance of Nasal Staphylococcus Aureus Colonization With Triple Antibiotic Ointment
- ClinicalTrials.gov ID
- NCT00997139
- Acronym / sponsor ID
- NU-9892
- Conditions
- Nasal Carriers of Staphylococcus Aureus
- Keywords
- healthcare, staphylococcus aureus, nasal
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 216 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Study start
- Sep 2009
- Primary completion
- Nov 2010 (actual)
- Study completion
- Nov 2010 (actual)
- First posted
- 19 Oct 2009 (estimated)
- Results
- Posted 8 May 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Staphylococcus aureus, a bacteria that lives commonly in the anterior nostrils, is seen in about 30% of healthcare workers. Applying mupirocin ointment, a prescription, to the nostrils twice daily for 5 days is the current standard of care for treatment to clear this bacteria. This research study is designed to determine the rate of clearance of this bacteria in healthcare workers who are carriers when using triple antibiotic ointment instead of mupirocin ointment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Willing and able to give informed consent
- Must have consented prior to registration for the study
Key exclusion criteria (6 listed)
- active infection
- concurrent treatment with antibiotics, topical or systemic
- S. aureus decolonization attempt in prior six months
- history of HIV
- chemotherapy or systemic immunosuppressive therapy
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 |
|---|---|---|
| Neosporin (polymyxin B 5,000units, bacitracin 400 units, neomycin 3.5mg)2 1/32oz packages will be dispensed. If positive nasal swab for S. aureus, subjects will apply a small amount to anterior nares twice daily for 5 days. | Drug | – |
Primary outcome
Carrier Rate for Staphylococcus Aureus
Time frame: Baseline
Percentage of subjects with baseline culture positive for Staphylococcus aureus (via nasal swab)
MSSA Clearance Rate
Time frame: 14 days
Percentage of subjects with methicillin-sensitive S. aureus on Baseline culture who achieved clearance with treatment.
MRSA Clearance Rate
Time frame: 14 days
Percentage of subjects with methicillin-resistant S. aureus on Baseline culture who achieved clearance with treatment.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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.
Peter Lio, MD principal investigator
Northwestern Unviersity
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neosporin (polymyxin B 5,000units, bacitracin 400 units, neomycin 3.5mg) in people with Nasal Carriers of Staphylococcus Aureus, run by Northwestern University 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 2 inclusion and 6 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 5 Jan 2015. 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?
Yes. Results are posted in the registry (first posted 8 May 2012). 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?
Carrier Rate for Staphylococcus Aureus (time frame: Baseline). The study lists 3 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 5 Jan 2015.