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

Methicillin-resistant Staphylococcus Aureus Clinical Trial

— TOPS-MRSA  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00903279
• Other study ID #: TOPS2009
• Status: Withdrawn
• Phase: Phase 2
• First received: May 14, 2009
• Last updated: January 30, 2017
• Start date: August 2009
• Est. completion date: December 2010

Study information

• Verified date: May 2009
• Source: Bay Pines VA Healthcare System
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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)

Related Conditions & MeSH terms

• Methicillin-resistant Staphylococcus Aureus
• Orthopedic Procedures
• Staphylococcal Infections

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Bay Pines VAHCS	Bay Pines	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Bay Pines VA Healthcare System

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluate efficacy of Retapamulin 1% ointment in eliminating patients MRSA colonization		30 days
Secondary	Identify a predominant clone among the MRSA isolates in this study		2 years