Comparison of Decolonization of Methicillin-resistant Staphylococcus Aureus (MRSA) Using Theraworx (SJMRSA)
Primary Purpose
Methicillin-Resistant Staphylococcus Aureus
Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Theraworx
mupirocin antibiotic ointment
Sponsored by
About this trial
This is an interventional treatment trial for Methicillin-Resistant Staphylococcus Aureus focused on measuring Methicillin resistance
Eligibility Criteria
Inclusion Criteria:
- Positive MRSA culture
Exclusion Criteria:
- Patients currently on or start antibiotic therapy directed for MRSA.(Prophylaxis antibiotic for surgical procedure not considered therapy.)
- Patients with MRSA infected wounds
- Patients under the age of 18 years
- A woman currently pregnant or nursing a child
- Patients participating in another study within 30 days of randomization
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
No Intervention
Experimental
Active Comparator
Arm Label
1
2
3
Arm Description
No Treatment
Theraworx intranasal
mupirocin antibiotic ointment intranasal
Outcomes
Primary Outcome Measures
Evidence of decolonization confirmed by intranasal culture
Secondary Outcome Measures
Economic-Cost comparison of treatment Evidence of decolonization
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00713674
Brief Title
Comparison of Decolonization of Methicillin-resistant Staphylococcus Aureus (MRSA) Using Theraworx
Acronym
SJMRSA
Official Title
Comparison of Decolonization of MRSA Using Theraworx
Study Type
Interventional
2. Study Status
Record Verification Date
March 2017
Overall Recruitment Status
Withdrawn
Why Stopped
Lack of patient recruitment.
Study Start Date
March 2008 (undefined)
Primary Completion Date
February 2009 (Actual)
Study Completion Date
February 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mercy Research
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to examine treatment method of Methicillin-resistant Staphylococcus aureus (MRSA) decolonization in patients.
Detailed Description
Decolonization therapy is indicated for management of patients with MRSA. Theraworx is reported to be an effective antimicrobial against multiple organisms. In this study, patients with positive MRSA colonization culture will be treated with Theraworx to evaluate decolonization duration capability.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Methicillin-Resistant Staphylococcus Aureus
Keywords
Methicillin resistance
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
No Intervention
Arm Description
No Treatment
Arm Title
2
Arm Type
Experimental
Arm Description
Theraworx intranasal
Arm Title
3
Arm Type
Active Comparator
Arm Description
mupirocin antibiotic ointment intranasal
Intervention Type
Other
Intervention Name(s)
Theraworx
Intervention Description
Theraworx swab intranasal BID for 5 days
Intervention Type
Drug
Intervention Name(s)
mupirocin antibiotic ointment
Intervention Description
mupirocin antibiotic ointment swab intranasal BID for 5 days
Primary Outcome Measure Information:
Title
Evidence of decolonization confirmed by intranasal culture
Time Frame
Up to 14 days post treatment (+/- 1-2 days)
Secondary Outcome Measure Information:
Title
Economic-Cost comparison of treatment Evidence of decolonization
Time Frame
5 days of treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Positive MRSA culture
Exclusion Criteria:
Patients currently on or start antibiotic therapy directed for MRSA.(Prophylaxis antibiotic for surgical procedure not considered therapy.)
Patients with MRSA infected wounds
Patients under the age of 18 years
A woman currently pregnant or nursing a child
Patients participating in another study within 30 days of randomization
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Roger E Huckfeldt, MD
Organizational Affiliation
Mercy/St. John's Hospital - Springfield
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Comparison of Decolonization of Methicillin-resistant Staphylococcus Aureus (MRSA) Using Theraworx
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