HemodialysisNCT00977496
Development of a Probiotic Strategy to Prevent or Eliminate Nasal Colonization With S. Aureus
An observational study of Hemodialysis, run by Tufts Medical Center.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hemodialysis
- What is being tested?
- Nasal Swab
- Type of treatment
- Surgery or procedure
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- May 2011to not given
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients from the Boston Dialysis Center Inc outpatient hemodialysis clinic of Tufts Medical Center.
Who may be able to join
- 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
Who cannot join
- 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
About this study
Official title: 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.
- Conditions
- Hemodialysis
- Being tested
- Nasal Swab
- Keywords
- hemodialysis, microbiota, Staphylococcus aureus
- Medical subject headings
- Staphylococcal Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nasal SwabProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Procedure: Nasal Swab |
What is being measured
The primary outcome is the main question the study is designed to answer.
To describe the clinical variables that may be associated with the acquisition of S aureus nasal colonization, over a six-month period.
Measured: 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.
Measured: 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.
Measured: Monthly for 6 months or monthly until 1 month after positive nasal swab for S aureus
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2009 (estimated)
- Study startMay 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HemodialysisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tufts Medical Center
- Sponsor type
- University, hospital or other
- Investigators
- Patricia L Hibberd, MD, PhD, Principal investigator, Tufts Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00977496
- Sponsor's protocol ID
- 8784
- Status last verified
- Mar 2015
- First submitted
- 14 Sep 2009
- Last updated
- 18 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a Probiotic Strategy to Prevent or Eliminate Nasal Colonization With S Aureus
- ClinicalTrials.gov ID
- NCT00977496
- Acronym / sponsor ID
- 8784
- Conditions
- Hemodialysis
- Keywords
- hemodialysis, microbiota, Staphylococcus aureus
- Study type
- Observational
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Tufts Medical CenterUniversity, hospital or other
- Study start
- May 2011
- First posted
- 15 Sep 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Nasal Swab | – | Procedure: Nasal SwabNew 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients from the Boston Dialysis Center Inc outpatient hemodialysis clinic of Tufts Medical Center.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nasal SwabSwabs 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. | Procedure or surgery | Nasal Swab |
Primary outcome
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
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Patricia L Hibberd, MD, PhD principal investigator
Tufts Medical Center
Questions about this trial
What is this clinical trial studying?
An observational study of Hemodialysis, run by Tufts Medical Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 18 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2015.