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

NCT00977496 | Withdrawn

• 1 other identifier: 8784
• Study Type: observational
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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 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.

Conditions

Hemodialysis

Keywords

hemodialysis; microbiota; Staphylococcus aureus

Outcome Measures

Primary Outcomes (3)

• To describe the clinical variables that may be associated with the acquisition of S aureus nasal colonization, over a six-month period.

  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.

  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.

  Monthly for 6 months or monthly until 1 month after positive nasal swab for S aureus

Study Arms (1)

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

Procedure: Nasal Swab

Interventions

Nasal Swab PROCEDURE

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Tufts Medical Center: lead

MeSH Terms

Conditions

Staphylococcal Infections

Condition Hierarchy (Ancestors)

Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Study Officials

• Patricia L Hibberd, MD, PhD

  Tufts Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 14, 2009
• First Posted: September 15, 2009
• Study Start: May 1, 2011
• Last Updated: March 18, 2015

Record last verified: 2015-03