- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00997139
Clearance of Nasal Staphylococcus Aureus With Triple Antibiotic Ointment
December 11, 2014 updated by: Dennis West, Northwestern University
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
216
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Illinois
-
Chicago, Illinois, United States, 60611
- Northwestern University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Willing and able to give informed consent
- Must have consented prior to registration for the study
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Carrier Rate for Staphylococcus Aureus
Time Frame: Baseline
|
Percentage of subjects with baseline culture positive for Staphylococcus aureus (via nasal swab)
|
Baseline
|
MSSA Clearance Rate
Time Frame: 14 days
|
Percentage of subjects with methicillin-sensitive S. aureus on Baseline culture who achieved clearance with treatment.
|
14 days
|
MRSA Clearance Rate
Time Frame: 14 days
|
Percentage of subjects with methicillin-resistant S. aureus on Baseline culture who achieved clearance with treatment.
|
14 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Peter Lio, MD, Northwestern Unviersity
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2009
Primary Completion (Actual)
November 1, 2010
Study Completion (Actual)
November 1, 2010
Study Registration Dates
First Submitted
October 15, 2009
First Submitted That Met QC Criteria
October 16, 2009
First Posted (Estimate)
October 19, 2009
Study Record Updates
Last Update Posted (Estimate)
January 5, 2015
Last Update Submitted That Met QC Criteria
December 11, 2014
Last Verified
December 1, 2014
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Infections
- Bacterial Infections
- Bacterial Infections and Mycoses
- Gram-Positive Bacterial Infections
- Staphylococcal Infections
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents, Local
- Anti-Infective Agents
- Enzyme Inhibitors
- Anti-Bacterial Agents
- Protein Synthesis Inhibitors
- Neomycin
- Polymyxins
- Bacitracin
- Polymyxin B
- Bacitracin zinc, neomycin sulfate, polymyxin B, drug combination
Other Study ID Numbers
- NU-9892
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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