- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00903279
Treatment of Patients Colonized With Methicillin-Resistant Staphylococcus Aureus Prior to Bone and Joint Surgery (TOPS-MRSA)
January 30, 2017 updated by: Bay Pines VA Healthcare System
Treatment of Patients Colonized With Methicillin-Resistant Staphylococcus Aureus Prior to Bone and Joint Surgery (TOPS-MRSA)
The investigators anticipate that utilization of retapamulin preoperatively will eliminate MRSA colonization among patients who are colonized in their nares.
Study Overview
Status
Withdrawn
Intervention / Treatment
Detailed Description
Enhanced characterization of MRSA strains carried by patients and their eradication prior to surgery will significantly reduce healthcare costs to the VA by reducing the number of MRSA positive patients who need to be isolated and or closely monitored, and allow healthcare providers to better predict the patient's requirements.
In addition, the application of molecular methods will facilitate faster tracking of MRSA postoperative infections.
Study Type
Interventional
Phase
- Phase 2
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
-
-
Florida
-
Bay Pines, Florida, United States, 33744
- Bay Pines VAHCS
-
-
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
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Patients who are admitted for an orthopedic surgical procedure
- All patients will be screened and admitted to the study prior to surgery regardless of eventual culture results for MRSA
Exclusion Criteria:
- Pregnancy
- Serious systemic illness due to renal, cardiac or hepatic disease
- Inability to complete follow-up assessments
- Allergy or intolerance to retapamulin
- BMI > 30
- Uncontrolled diabetes, severe anemia, thrombocytopenia or an underlying hematopoietic disorder or malignancy
- Patients with serious life-threatening illnesses and those with terminal illness not expected to survive for two years or more will not be enrolled
- Antibiotics administered during the course of the study will be recorded (name, dose and dates)
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: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Placebo
|
Placebo will be administered intranasally an amount approximating 0.25 ml will be applied to each nasal vestibule by sterile cotton applicator in the evening prior to surgery and immediately on call on the day of surgery.
|
Experimental: Altabax
|
Retapamulin 1% ointment will be administered intranasally an amount approximating 0.25 ml will be applied to each nasal vestibule by sterile cotton applicator in the evening prior to surgery and immediately on call on the day of surgery.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Evaluate efficacy of Retapamulin 1% ointment in eliminating patients MRSA colonization
Time Frame: 30 days
|
30 days
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Identify a predominant clone among the MRSA isolates in this study
Time Frame: 2 years
|
2 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Suzane Silbert, PhD, Bay Pines VAHCS
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
August 1, 2009
Primary Completion
December 7, 2022
Study Completion (Anticipated)
December 1, 2010
Study Registration Dates
First Submitted
May 14, 2009
First Submitted That Met QC Criteria
May 14, 2009
First Posted (Estimate)
May 18, 2009
Study Record Updates
Last Update Posted (Estimate)
January 31, 2017
Last Update Submitted That Met QC Criteria
January 30, 2017
Last Verified
May 1, 2009
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- TOPS2009
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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