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

Sponsor

Bay Pines VA Healthcare System (U.S. Fed)

Overall Status

Withdrawn

CT.gov ID

NCT00903279

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

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

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 Design

Study Type:

Interventional

Actual Enrollment :

0 participants

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)

Study Start Date :

Aug 1, 2009

Anticipated Study Completion Date :

Dec 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
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 Names: Retapamulin

Arm

Intervention/Treatment

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 Names:

Retapamulin

Outcome Measures

Primary Outcome Measures

Evaluate efficacy of Retapamulin 1% ointment in eliminating patients MRSA colonization [30 days]

Secondary Outcome Measures

Identify a predominant clone among the MRSA isolates in this study [2 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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)