End Stage Renal Failure on DialysisPhase 2NCT01214395
Nasal Tea Tree Oil for the Prevention of Infections in PD Patients
A Phase 2 study testing 5% tea tree oil nasal ointment in people with End Stage Renal Failure on Dialysis, run by PathWest Laboratory Medicine WA at 1 site in Australia.
Trial summary
This study will compare the use of tea tree oil as a topical nasal antiseptic to prevent infections in patients that need renal dialysis. A maximum of fifty subjects will be recruited and will be assessed for signs of infection once per week for the first 6 weeks and then every 4 weeks until week 26. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- End Stage Renal Failure on Dialysis
- What is being tested?
- 5% tea tree oil nasal ointment
- How many people
- 5 participants
- Where
- 1 siteAustralia
- Study dates
- Jun 2010to Dec 2011
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men or women over 18 years of age
- A signed and dated written informed consent is obtained prior to participation.
- Able to comply with the requirements of the protocol.
- Have ESRD and dialysis is planned
- Requirement either haemodialysis or peritoneal dialysis
Who cannot join
- known sensitivity to TTO
- Use of mediated and non-medicated nasal ointments in the past 12 weeks
- HD patients likely to transfer to a another dialysis centre in the next 6 months
- Re-insertion of CVC
- serious, uncontrolled disease (including serious psychological disorders) likely to interfere with the study and/or likely to cause death within the study duration
- participation in another clinical trial during the last 12 weeks
Show all 20Show fewer
- previous participation in this trial
- known contraindication to any component of mupirocin
- concurrent diseases which exclude the administration of therapy as outlined by the study protocol
- active infections requiring systemically administered antibiotics or antiviral medications within the last 7 days
- acute renal failure
- non-compensated heart failure
- myocardial infarction during the last 6 months
- chronic lung disease with hypoxemia
- severe non-compensated hypertension
- severe non-compensated diabetes mellitus
- known HIV or active chronic hepatitis B or C infection
- subjects who, in the opinion of the investigator, are not likely to complete the study for what ever reason.
- subjects who, in the opinion of the investigator, abuse alcohol or drugs
- subjects with any clinically significant abnormality (to be determined by the investigator) following review of screening laboratory data and full physical examination. Stable medical conditions unlikely to affect patient safety or the outcome of the investigation may be acceptable if agreed by the study monitor appointed by the sponsor
Trial locations and contacts
1 site in 1 country.
Australia1 site
Sir Charles Gairdner Hospital
Perth, Western Australia, 6009
About this study
Official title: An Investigator Blinded Controlled Study of the Nasal Application of 5% Tea Tree Oil (TTO) for the Prevention of Catheter-associated Infections in Renal Dialysis Patients
This study will compare the use of tea tree oil as a topical nasal antiseptic to prevent infections in patients that need renal dialysis. A maximum of fifty subjects will be recruited and will be assessed for signs of infection once per week for the first 6 weeks and then every 4 weeks until week 26. They will also be checked for nasal carriage of 'Golden Staph' when they enroll in the trial. The subjects will complete the trial if they have 26 weeks infection-free or if they have an infection during that period
Read the detailed description
The patients for the trial are to be recruited in the Renal Unit at SCGH and at enrolment a nasal swab is taken to see if the patients has nasal carriage of S. aureus. The patient is also given a prescription for 5% TTO nasal ointment which was filled by the SCGH pharmacy. The application of medication will follow the usual procedure which consists of bi-daily nasal application for 5 days and then weekly application for the next 25 weeks of the trial. The patients are not blinded and are given all their medication at one dispensing which consists of 3 × 10 g tubes of 5% TTO. The patients have weekly assessments for the first 6 weeks of the trial and then 4 weekly assessments until week 26. All assessments are conducted during routine dressing changes or routine visits and are conducted by specially trained dialysis nurses. During each visit the catheter site is examined for any signs of infection and the findings documented on a questionnaire. Suspected cases of infection are identified by trained nurses and the consultant physician will then examined the patient. The findings will be documented by the nurse on a questionnaire and submitted to the primary investigator for review, confirmation, and classification. The primary endpoint is the proportion of patients with a catheter-related infection within 6 months after entry into the study. The infections included: (1) exit site infection (ESI); (2) tunnel infections; and (3) bacteraemia. The endpoint is evaluated by the primary investigator according to the definitions for catheter-related infections. Cases with "definite" and "probable" infections will be classified as infections.
All catheter-related infections are treated by the patient's nephrologist according to their usual practice. If a new catheter is clinically indicated, the patient will continued to receive the same ointment to which they had been assigned. Swabs for cultures and sensitivities at the catheter exit site are taken if an exit or tunnel infection is suspected and blood cultures if a bacteraemia is suspected. All microbiology samples will be sent to the PathWest laboratory for culture and sensitivities. The study will end when the last enrolled subject has completed the minimum 6-month study period.
- Conditions
- End Stage Renal Failure on Dialysis
- Being tested
- 5% tea tree oil nasal ointment
- Keywords
- haemodialysis, peritoneal dialysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
5% tea tree oil nasal ointmentDrug
daily for 5 days then weekly for 6 months
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Endpoint Will be the Number of Tea Tree Oil Patients That Did Not Have a Catheter-related Infection Within 6 Months After Entry Into the Trial.
Catheter-related infections will be defined according to standard guidelines
Cases with "definite" and "probable" infections will be classified as infections.
Measured: 6 months
Secondary outcomes (1)
The Number of Patients That Did Not Have a Staphylococcus Aureus Infection
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2010 (estimated)
- Study startJun 2010
- Primary completionNov 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for End Stage Renal Failure on DialysisStudies 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- PathWest Laboratory Medicine WA
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Kerry Carson, PathWest Laboratory Medicine WA
- Investigators
- Brian Hutchison, MBBS, Principal investigator, Sir Charles Gairdner Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01214395
- Sponsor's protocol ID
- 2006-199
- Status last verified
- Jun 2012
- First submitted
- 4 Oct 2010
- Last updated
- 3 Aug 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Investigator Blinded Controlled Study of the Nasal Application of 5% Tea Tree Oil (TTO) for the Prevention of Catheter-associated Infections in Renal Dialysis Patients
- ClinicalTrials.gov ID
- NCT01214395
- Acronym / sponsor ID
- 2006-199
- Conditions
- End Stage Renal Failure on Dialysis
- Keywords
- haemodialysis, peritoneal dialysis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- PathWest Laboratory Medicine WAOther government
- Study start
- Jun 2010
- Primary completion
- Nov 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 5 Oct 2010 (estimated)
- Results
- Posted 3 Aug 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will compare the use of tea tree oil as a topical nasal antiseptic to prevent infections in patients that need renal dialysis. A maximum of fifty subjects will be recruited and will be assessed for signs of infection once per week for the first 6 weeks and then every 4 weeks until week 26. They will also be checked for nasal carriage of 'Golden Staph' when they enroll in the trial. The subjects will complete the trial if they have 26 weeks infection-free or if they have an infection during that period
Detailed description
The patients for the trial are to be recruited in the Renal Unit at SCGH and at enrolment a nasal swab is taken to see if the patients has nasal carriage of S. aureus. The patient is also given a prescription for 5% TTO nasal ointment which was filled by the SCGH pharmacy. The application of medication will follow the usual procedure which consists of bi-daily nasal application for 5 days and then weekly application for the next 25 weeks of the trial. The patients are not blinded and are given all their medication at one dispensing which consists of 3 × 10 g tubes of 5% TTO. The patients have weekly assessments for the first 6 weeks of the trial and then 4 weekly assessments until week 26. All assessments are conducted during routine dressing changes or routine visits and are conducted by specially trained dialysis nurses. During each visit the catheter site is examined for any signs of infection and the findings documented on a questionnaire. Suspected cases of infection are identified by trained nurses and the consultant physician will then examined the patient. The findings will be documented by the nurse on a questionnaire and submitted to the primary investigator for review, confirmation, and classification. The primary endpoint is the proportion of patients with a catheter-related infection within 6 months after entry into the study. The infections included: (1) exit site infection (ESI); (2) tunnel infections; and (3) bacteraemia. The endpoint is evaluated by the primary investigator according to the definitions for catheter-related infections. Cases with "definite" and "probable" infections will be classified as infections.
All catheter-related infections are treated by the patient's nephrologist according to their usual practice. If a new catheter is clinically indicated, the patient will continued to receive the same ointment to which they had been assigned. Swabs for cultures and sensitivities at the catheter exit site are taken if an exit or tunnel infection is suspected and blood cultures if a bacteraemia is suspected. All microbiology samples will be sent to the PathWest laboratory for culture and sensitivities. The study will end when the last enrolled subject has completed the minimum 6-month study period.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Men or women over 18 years of age
- A signed and dated written informed consent is obtained prior to participation.
- Able to comply with the requirements of the protocol.
- Have ESRD and dialysis is planned
- Requirement either haemodialysis or peritoneal dialysis
Key exclusion criteria (20 listed)
- known sensitivity to TTO
- Use of mediated and non-medicated nasal ointments in the past 12 weeks
- HD patients likely to transfer to a another dialysis centre in the next 6 months
- Re-insertion of CVC
- serious, uncontrolled disease (including serious psychological disorders) likely to interfere with the study and/or likely to cause death within the study duration
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 |
|---|---|---|
| 5% tea tree oil nasal ointmentdaily for 5 days then weekly for 6 months | Drug | – |
Primary outcome
Primary Endpoint Will be the Number of Tea Tree Oil Patients That Did Not Have a Catheter-related Infection Within 6 Months After Entry Into the Trial.
Time frame: 6 months
Catheter-related infections will be defined according to standard guidelines Cases with "definite" and "probable" infections will be classified as infections.
1 secondary outcome
The Number of Patients That Did Not Have a Staphylococcus Aureus Infection
Time frame: 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Brian Hutchison, MBBS principal investigator
Sir Charles Gairdner Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 5% tea tree oil nasal ointment in people with End Stage Renal Failure on Dialysis, run by PathWest Laboratory Medicine WA at 1 site in Australia.
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 5 inclusion and 20 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: finished, as of the sponsor's last update on 3 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Aug 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Primary Endpoint Will be the Number of Tea Tree Oil Patients That Did Not Have a Catheter-related Infection Within 6 Months After Entry Into the Trial. (time frame: 6 months). 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 3 Aug 2012.