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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This study has been withdrawn prior to enrollment.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:
ClinicalTrials.gov Identifier:
NCT00903279
First Posted: May 18, 2009
Last Update Posted: January 31, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Bay Pines VA Healthcare System
  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
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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:


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 ]

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

Enrollment: 0
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

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: David P. Johnson, MD, Bay Pines VAHCS
ClinicalTrials.gov Identifier: NCT00903279     History of Changes
Other Study ID Numbers: TOPS2009
First Submitted: May 14, 2009
First Posted: May 18, 2009
Last Update Posted: January 31, 2017
Last Verified: May 2009

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