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

B

Bay Pines VA Healthcare System

Status and phase

Withdrawn
Phase 2

Conditions

Methicillin-resistant Staphylococcus Aureus
Orthopedic Procedures

Treatments

Drug: Altabax (retapamulin)
Drug: Placebo

Study type

Interventional

Funder types

Other U.S. Federal agency

Identifiers

NCT00903279
TOPS2009

Details and patient eligibility

About

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

Full 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.

Sex

All

Volunteers

Accepts Healthy Volunteers

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)

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

0 participants in 2 patient groups, including a placebo group

Placebo
Placebo Comparator group
Treatment:
Drug: Placebo
Altabax
Experimental group
Treatment:
Drug: Altabax (retapamulin)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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