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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01214395




Registration number
NCT01214395
Ethics application status
Date submitted
4/10/2010
Date registered
5/10/2010
Date last updated
3/08/2012

Titles & IDs
Public title
Nasal Tea Tree Oil for the Prevention of Infections in PD Patients
Scientific 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
Secondary ID [1] 0 0
2006-199
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
End Stage Renal Failure on Dialysis 0 0
Condition category
Condition code
Renal and Urogenital 0 0 0 0
Kidney disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - 5% tea tree oil nasal ointment

Treatment: Drugs: 5% tea tree oil nasal ointment
daily for 5 days then weekly for 6 months
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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.
Timepoint [1] 0 0
6 months
Secondary outcome [1] 0 0
The Number of Patients That Did Not Have a Staphylococcus Aureus Infection
Timepoint [1] 0 0
6 months

Eligibility
Key inclusion criteria
* 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
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* 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
* 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

Study design
Purpose of the study
Prevention
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/06/2010
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/12/2011
Sample size
Target
Accrual to date
Final
5
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 0 0
Sir Charles Gairdner Hospital - Perth
Recruitment postcode(s) [1] 0 0
6009 - Perth

Funding & Sponsors
Primary sponsor type
Government body
Name
PathWest Laboratory Medicine WA
Address
Country

Ethics approval
Ethics application status

Summary
Brief 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. 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
Trial website
https://clinicaltrials.gov/study/NCT01214395
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Brian Hutchison, MBBS
Address 0 0
Sir Charles Gairdner Hospital
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT01214395