Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000874011
Ethics application status
Approved
Date submitted
15/10/2010
Date registered
18/10/2010
Date last updated
10/05/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
The use of 5% tea tree oil for the prevention of infections in renal dialysis patients
Scientific title
An investigator blinded controlled study of the nasal application of 5% tea tree oil (TTO) versus mupirocin for the prevention of catheter-associated infections in renal dialysis patients
Secondary ID [1] 252822 0
NCT01214395
Universal Trial Number (UTN)
U1111-1117-3394
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Infection in renal dialysis patients 258309 0
Condition category
Condition code
Alternative and Complementary Medicine 258501 258501 0 0
Other alternative and complementary medicine
Infection 258598 258598 0 0
Studies of infection and infectious agents
Renal and Urogenital 258599 258599 0 0
Kidney disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Use of 5% tea tree oil ointment as a nasal treatment instead of 2% mupirocin cream to eradicate nasal carriage of Staphylococcus aureus in renal dialysis patients. The mode of administration is 0.25g per nostril applied topically inside nostrils for both 5% tea tree oil ointment and 2% mupirocin cream and treatment time is daily for the first 5 days and then weekly for 26 weeks.
Intervention code [1] 257328 0
Treatment: Drugs
Intervention code [2] 257430 0
Treatment: Other
Intervention code [3] 257431 0
Prevention
Comparator / control treatment
0.25 g of 2% mupirocin cream applied topically inside each nostril daily for the first 5 days and then weekly for 26 weeks
Control group
Active

Outcomes
Primary outcome [1] 259336 0
Primary endpoint will be the proportions of TTO and mupirocin patients that have a catheter-related infection within 26 weeks after entry into the study. Catheter related infections will be defined as according to standard guidelines-
1. definite exit site infection if purulent discharge is present , or 2 out of 3 of erythema, tenderness and duration with a positive culture of bacteria from the exudate
2. tunnel infection will be defined as 2 out of 3 of erythema, tenderness and duration >2cm from the catheter exit site along the subcutaneous tract of a tunnel catheter, with or without concomitant blood stream infection
3. definite catheter-associated bacteraemia will be defined as a single positive blood culture together with a positive culture of the catheter tip or exit site with an identical organism
4. a probable catheter-associated bacteraemia is recorded if there are 2 or more positive blood cultures (or a single blood culture of Staphylococcus aureus) with no evidence of infection source other than the device
Cases with definite or probable infections will be classed as infections. Comparisons between the two groups will be performed using Student's t-test or the Mann-Whitney U test depending on data distribution. Differences in proportions will be evaluated by the Chi Square or Fisher's Exact tests
Timepoint [1] 259336 0
At the end of the study which is 26 weeks for those who have not had an infection and the time of infection (end of study) for those who have an infection
Secondary outcome [1] 265786 0
Secondary endpoints will be infection-free survival between the two treatment groups according to Kaplan-Meier method. Survival curves between the two groups will be evaluated using log rank test
Timepoint [1] 265786 0
End of the study at 26 weeks for those who have not had an infection and the time of infection (end of study) for those who have an infection
Secondary outcome [2] 265787 0
survival probabilities between the two treatment groups according to Kaplan-Meier method. Survival curves between the two groups will be evaluated using log rank test
Timepoint [2] 265787 0
End of the study at 26 weeks for those who have not had an infection and the time of infection (end of study) for those who have an infection
Secondary outcome [3] 265788 0
estimated mean survival times between the two treatment groups according to Kaplan-Meier method. Survival curves between the two groups will be evaluated using log rank test
Timepoint [3] 265788 0
End of the study at 26 weeks for those who have not had an infection and the time of infection (end of study) for those who have an infection

Eligibility
Key inclusion criteria
Have ESRD
Haemodialysis or peritoneal dialysis planned
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Known sensitivity to tea tree oil
Use of medicated and non-medicated nasal ointments in the past 12 weeks
Serious, uncontrolled disease (including serious psychological disorders) likely to interfere with the study and/or likely to cause death within the study duration
Acute renal failure

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Patient will be enrolled after consent has been obtained. A nasal swab will be taken and after a catheter has been inserted they will be prescribed trail medication from hospital pharmacy. The pharmacy holds the randomised list of patient numbers and trial medication allocated
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The medication will be randomised using a block
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/08/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 257768 0
Government body
Name [1] 257768 0
Rural Industry Research Development Corporation
Country [1] 257768 0
Australia
Primary sponsor type
University
Name
The University of Western Australia
Address
Stirling highway
Crawley WA 6009
Country
Australia
Secondary sponsor category [1] 256980 0
None
Name [1] 256980 0
Address [1] 256980 0
Country [1] 256980 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259810 0
Sir Charles Gairdner Hospital Group Human Research Ethics Committee
Ethics committee address [1] 259810 0
Ethics committee country [1] 259810 0
Australia
Date submitted for ethics approval [1] 259810 0
Approval date [1] 259810 0
28/02/2008
Ethics approval number [1] 259810 0
2006-199

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31726 0
Address 31726 0
Country 31726 0
Phone 31726 0
Fax 31726 0
Email 31726 0
Contact person for public queries
Name 14973 0
Kerry Carson
Address 14973 0
Senior Research Scientist
Division of Microbiology & Infectious Diseases
Pathwest Laboratory Medicine WA
Hospital Ave
Nedlands WA 6009
Country 14973 0
Australia
Phone 14973 0
+61 8 9346 4092
Fax 14973 0
Email 14973 0
[email protected]
Contact person for scientific queries
Name 5901 0
Kerry Carson
Address 5901 0
Senior Research Scientist
Division of Microbiology & Infectious Diseases
Pathwest Laboratory Medicine WA
Hospital Ave
Nedlands WA 6009
Country 5901 0
Australia
Phone 5901 0
+61 8 9346 4092
Fax 5901 0
Email 5901 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.