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

Phase 2

Withdrawn

• Conditions: Orthopedic Procedures; Methicillin-resistant Staphylococcus Aureus
• Interventions: Drug: Placebo; Drug: Altabax (retapamulin)

• Registration Number: NCT00903279
• Lead Sponsor: Bay Pines VA Healthcare System

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.

Study Timeline

• Status Verified: 2009-05
• Study First Submitted: 2009-05-14
• Study First Submitted QC: 2009-05-14
• Study First Posted: 2009-05-18
• Study Start: 2009-08
• Study Completion: 2010-12
• Last Update Submitted: 2017-01-30
• Last Update Posted: 2017-01-31

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
Altabax	Altabax (retapamulin)	-

Primary Outcome Measures

Name	Time	Method
Evaluate efficacy of Retapamulin 1% ointment in eliminating patients MRSA colonization	30 days

Secondary Outcome Measures

Name	Time	Method
Identify a predominant clone among the MRSA isolates in this study	2 years

Trial Locations

Locations (1)

Bay Pines VAHCS; 🇺🇸 Bay Pines, Florida, United States