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Treatment of Patients Colonized With Methicillin-Resistant Staphylococcus Aureus Prior to Bone and Joint Surgery (TOPS-MRSA)

This study has been withdrawn prior to enrollment.
(Funding)
Sponsor:
Information provided by:
Bay Pines VA Healthcare System
ClinicalTrials.gov Identifier:
NCT00903279
First received: May 14, 2009
Last updated: October 7, 2010
Last verified: May 2009
History of Changes
  Purpose

The investigators anticipate that utilization of retapamulin preoperatively will eliminate MRSA colonization among patients who are colonized in their nares.


Condition Intervention Phase
Orthopedic Procedures
Methicillin-resistant Staphylococcus Aureus
 Drug: Placebo
Drug: Altabax (retapamulin)
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Treatment of Patients Colonized With Methicillin-Resistant Staphylococcus Aureus Prior to Bone and Joint Surgery (TOPS-MRSA)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Bay Pines VA Healthcare System:

Primary Outcome Measures:
  • Evaluate efficacy of Retapamulin 1% ointment in eliminating patients MRSA colonization [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Identify a predominant clone among the MRSA isolates in this study [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 400
Study Start Date: August 2009
Estimated Study Completion Date: December 2010
Arms Assigned Interventions
Placebo Comparator: Placebo Drug: 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 Drug: Altabax (retapamulin)
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 Name: Retapamulin

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00903279

Locations
United States, Florida
Bay Pines VAHCS
Bay Pines, Florida, United States, 33744
Sponsors and Collaborators
Bay Pines VA Healthcare System
Investigators
Study Director: Suzane Silbert, PhD Bay Pines VAHCS
  More Information

No publications provided

Responsible Party: David P. Johnson, MD, Bay Pines VAHCS
ClinicalTrials.gov Identifier: NCT00903279     History of Changes
Other Study ID Numbers: TOPS2009
Study First Received: May 14, 2009
Last Updated: October 7, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Bay Pines VA Healthcare System:
MRSA colonization
Orthopedic Surgery
Altabax
Placebo

Additional relevant MeSH terms:
Staphylococcal Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Methicillin
 Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 17, 2013