Status:
WITHDRAWN
Development of a Probiotic Strategy to Prevent or Eliminate Nasal Colonization With S. Aureus
Lead Sponsor:
Tufts Medical Center
Conditions:
Hemodialysis
Eligibility:
All Genders
18+ years
Brief Summary
The goal of this study is characterize the changes in bacterial diversity of the nares of hemodialysis patients. Another goal is to determine when hemodialysis patients become colonized with the bacte...
Eligibility Criteria
Inclusion
- Male and female subjects aged 18 years or older
- On a stable hemodialysis schedule three times a week at Tufts Medical Center outpatient hemodialysis unit
- Able to speak English, Spanish, Cantonese, or Mandarin (One of these languages is spoken by \>95% of our hemodialysis population)
- Provides informed consent to participate in the study
- No plans to be absent from the dialysis unit in the next 6 months
- Willingness to report on adverse events during the study period
Exclusion
- Patients in which hemodialysis was indicated for acute renal failure secondary to septic shock, acute tubular necrosis, or other condition which is felt to be temporary or secondary to a life threatening illness or likelihood of hemodialysis for less than 6 months.
- Treatment with systemic anti-staphylococcal antibiotic therapy within 30 days prior to enrollment or planned use of topical mupirocin applied to the nares
- Receiving peritoneal dialysis (concordance between the colonizing and infecting strain is not as high as in the hemodialysis population (105))
- Absolute neutrophil count less than 500/mm3 or anticipated fall in neutrophil count \< 500/mm3 (e.g. as a result of recent chemotherapy)
- Bleeding diathesis such as platelets count less than 20 or INR \>4 within the last 30 days
- On immunosuppressive therapy
- Anticipated renal transplant during the next 6 months
- Evidence of active bowel leak, acute abdomen or colitis
Key Trial Info
Start Date :
May 1 2011
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00977496
Start Date
May 1 2011
Last Update
March 18 2015
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