Back to resultsTreatment of Patients Colonized With Methicillin-Resistant Staphylococcus Aureus Prior to Bone and Joint Surgery (TOPS-MRSA)
Primary Purpose
Orthopedic Procedures, Methicillin-resistant Staphylococcus Aureus
Status
Withdrawn
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Placebo
Altabax (retapamulin)
Sponsored by
About this trial
This is an interventional treatment trial for Orthopedic Procedures focused on measuring MRSA colonization, Orthopedic Surgery, Altabax, Placebo
Eligibility Criteria
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)
Sites / Locations
- Bay Pines VAHCS
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
Placebo
Altabax
Arm Description
Outcomes
Primary Outcome Measures
Evaluate efficacy of Retapamulin 1% ointment in eliminating patients MRSA colonization
Secondary Outcome Measures
Identify a predominant clone among the MRSA isolates in this study
Full Information
NCT ID
NCT00903279
First Posted
May 14, 2009
Last Updated
January 30, 2017
Sponsor
Bay Pines VA Healthcare System
1. Study Identification
Unique Protocol Identification Number
NCT00903279
Brief Title
Treatment of Patients Colonized With Methicillin-Resistant Staphylococcus Aureus Prior to Bone and Joint Surgery
Acronym
TOPS-MRSA
Official Title
Treatment of Patients Colonized With Methicillin-Resistant Staphylococcus Aureus Prior to Bone and Joint Surgery (TOPS-MRSA)
Study Type
Interventional
2. Study Status
Record Verification Date
May 2009
Overall Recruitment Status
Withdrawn
Why Stopped
Funding
Study Start Date
August 2009 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2010 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Bay Pines VA Healthcare System
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The investigators anticipate that utilization of retapamulin preoperatively will eliminate MRSA colonization among patients who are colonized in their nares.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Orthopedic Procedures, Methicillin-resistant Staphylococcus Aureus
Keywords
MRSA colonization, Orthopedic Surgery, Altabax, Placebo
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Title
Altabax
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Altabax (retapamulin)
Other Intervention Name(s)
Retapamulin
Intervention Description
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.
Primary Outcome Measure Information:
Title
Evaluate efficacy of Retapamulin 1% ointment in eliminating patients MRSA colonization
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Identify a predominant clone among the MRSA isolates in this study
Time Frame
2 years
10. Eligibility
Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Suzane Silbert, PhD
Organizational Affiliation
Bay Pines VAHCS
Official's Role
Study Director
Facility Information:
Facility Name
Bay Pines VAHCS
City
Bay Pines
State/Province
Florida
ZIP/Postal Code
33744
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Treatment of Patients Colonized With Methicillin-Resistant Staphylococcus Aureus Prior to Bone and Joint Surgery
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