Development of a Probiotic Strategy to Prevent or Eliminate Nasal Colonization With S. Aureus
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ClinicalTrials.gov Identifier: NCT00977496 |
Recruitment Status
:
Withdrawn
First Posted
: September 15, 2009
Last Update Posted
: March 18, 2015
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Condition or disease | Intervention/treatment |
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Hemodialysis | Procedure: Nasal Swab |
Study Type : | Observational |
Actual Enrollment : | 0 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | Development of a Probiotic Strategy to Prevent or Eliminate Nasal Colonization With S Aureus |
Study Start Date : | May 2011 |

Group/Cohort | Intervention/treatment |
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Nasal Swab
New chronic hemodialysis patients with no evidence of nasal carriage of Staphylococcus aureus from Boston Dialysis Center Inc., the outpatient hemodialysis clinic of Tufts Medical Center
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Procedure: Nasal Swab
Swabs will be moistened in sterile 0.9% sodium chloride solution and rotated in the anterior vestibule of both nares and processed for S aureus cultures and for bacterial DNA extraction.
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- To describe the clinical variables that may be associated with the acquisition of S aureus nasal colonization, over a six-month period. [ Time Frame: Monthly for 6 months or monthly until 1 month after positive nasal swab for S aureus ]
- To refine and test the feasibility of using non culture-based methods to study the microbial ecology and bacterial diversity of the anterior nares in patients starting hemodialysis using 16sRNA sequence analysis. [ Time Frame: Monthly for 6 months or monthly until 1 month after positive nasal swab for S aureus ]
- To explore changes in bacterial diversity in the anterior nares over a six-month period and in conjunction with S aureus colonization. [ Time Frame: Monthly for 6 months or monthly until 1 month after positive nasal swab for S aureus ]

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- 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 Criteria:
- 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00977496
Principal Investigator: | Patricia L Hibberd, MD, PhD | Tufts Medical Center |
Responsible Party: | Patricia Hibberd, MD, PhD, Tufts Medical Center |
ClinicalTrials.gov Identifier: | NCT00977496 History of Changes |
Other Study ID Numbers: |
8784 |
First Posted: | September 15, 2009 Key Record Dates |
Last Update Posted: | March 18, 2015 |
Last Verified: | March 2015 |
Keywords provided by Tufts Medical Center:
hemodialysis microbiota Staphylococcus aureus |