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CompletedNCT00997139Updated Jan 5, 2015Results posted

Clearance of Nasal Staphylococcus Aureus With Triple Antibiotic Ointment

An interventional study of Neosporin (polymyxin B 5,000units, bacitracin 400 units, neomycin 3.5mg) in Nasal Carriers of Staphylococcus Aureus, sponsored by Northwestern University. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-01-05.

Sponsored by Northwestern University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
216
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Nasal Carriers of Staphylococcus Aureus

Keywords

  • healthcare
  • staphylococcus aureus
  • nasal
03

In context

Staphylococcal Infections

273 studies on the registry are indexed under Staphylococcal Infections; 29 are open to participants now.

This study's enrollment of 216 is above the median of 120 across 177 interventional studies indexed under Staphylococcal Infections.

Browse Staphylococcal Infections studies →

Lead sponsor

Northwestern University is the lead sponsor of 1,396 studies on the registry; 199 are open to participants now.

Of its 102 completed or terminated interventional studies of FDA-regulated products, 73 (72%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Willing and able to give informed consent
  • Must have consented prior to registration for the study

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
216 participants (actual)

Interventions

  • DrugNeosporin (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.

06

What researchers measure

Primary outcomes

  1. Carrier Rate for Staphylococcus Aureus

    Percentage of subjects with baseline culture positive for Staphylococcus aureus (via nasal swab)

    Time frame: Baseline

  2. MSSA Clearance Rate

    Percentage of subjects with methicillin-sensitive S. aureus on Baseline culture who achieved clearance with treatment.

    Time frame: 14 days

  3. MRSA Clearance Rate

    Percentage of subjects with methicillin-resistant S. aureus on Baseline culture who achieved clearance with treatment.

    Time frame: 14 days

07

Results

Posted May 8, 2012

Participant flow

Participant flow — Overall Study
MilestoneAll Subjects
Started216
Treated for positive baseline culture30
Completed30
Not completed186

Outcome measures

PrimaryCarrier Rate for Staphylococcus Aureus

Percentage of subjects with baseline culture positive for Staphylococcus aureus (via nasal swab)

Time frame:
Baseline
Reported as:
Number · percentage of subjects
Carrier Rate for Staphylococcus Aureus
percentage of subjectsAll Subjects
Carrier Rate for Staphylococcus Aureus20.8
PrimaryMSSA Clearance Rate

Percentage of subjects with methicillin-sensitive S. aureus on Baseline culture who achieved clearance with treatment.

Time frame:
14 days
Reported as:
Number · percentage of subjects
MSSA Clearance Rate
percentage of subjectsMSSA
MSSA Clearance Rate57.1
PrimaryMRSA Clearance Rate

Percentage of subjects with methicillin-resistant S. aureus on Baseline culture who achieved clearance with treatment.

Time frame:
14 days
Reported as:
Number · percentage of subjects
MRSA Clearance Rate
percentage of subjectsMRSA
MRSA Clearance Rate0

Adverse events

Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
All Subjects—0/216 (0%)0/216 (0%)

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)Treatment Group
<=18 years0
Between 18 and 65 years30
>=65 years0
Age, Continuous
Age, Continuous(years)Treatment Group
Mean39.3 ± 10.9
Sex: Female, Male
Sex: Female, Male(Participants)Treatment Group
Female21
Male9
Region of Enrollment
Region of Enrollment(participants)Treatment Group
United States30
08

Study locations

1 site
  • Northwestern University
    Chicago, Illinois 60611, United States
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 5, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00997139
Lead sponsor
Northwestern University
Responsible party
Dennis West (Professor in Dermatology and Pediatrics, Northwestern University) — Principal investigator
First posted
Oct 19, 2009
Start date
Sep 2009
Primary completion
Nov 2010
Completion
Nov 2010
Results posted
May 8, 2012
Last update
Jan 5, 2015

Study contacts

Peter Lio, MD
principal investigator · Northwestern Unviersity

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2014. You cannot join it, but the record below documents what was studied.

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