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Development of a Probiotic Strategy to Prevent or Eliminate Nasal Colonization With S. Aureus

This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by:
Tufts Medical Center
ClinicalTrials.gov Identifier:
NCT00977496
First received: September 14, 2009
Last updated: November 17, 2010
Last verified: November 2010

September 14, 2009
November 17, 2010
May 2011
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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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00977496 on ClinicalTrials.gov Archive Site
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Development of a Probiotic Strategy to Prevent or Eliminate Nasal Colonization With S. Aureus
Development of a Probiotic Strategy to Prevent or Eliminate Nasal Colonization With S Aureus

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 bacteria Staphylococcus aureus, as nasal colonization with S. aureus is a major risk factor for invasive infection in hemodialysis patients. Fifteen subjects will be recruited into the study. Nasal swabs will be collected every month for six months or until one month after S. aureus colonization in order to determine any changes in the bacterial communities of the nose. Clinical data will also be collected to evaluate the possible influence of external factors on changes in the microbial communities in the patients' noses. This study will provide preliminary data on whether oral- and/or nasal-administered probiotics can eliminate nasal carriage of S. aureus.

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Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample

Patients from the Boston Dialysis Center Inc outpatient hemodialysis clinic of Tufts Medical Center.

Hemodialysis
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.
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
Intervention: Procedure: Nasal Swab
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
15
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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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
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NCT00977496
8784
No
Patricia Hibberd, MD, PhD, Tufts Medical Center
Tufts Medical Center
Not Provided
Principal Investigator: Patricia L Hibberd, MD, PhD Tufts Medical Center
Tufts Medical Center
November 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP