Status:
COMPLETED
Nasal Tea Tree Oil for the Prevention of Infections in PD Patients
Lead Sponsor:
PathWest Laboratory Medicine WA
Conditions:
End Stage Renal Failure on Dialysis
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
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 asse...
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 pres...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
June 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2011
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT01214395
Start Date
June 1 2010
End Date
December 1 2011
Last Update
August 3 2012
Active Locations (1)
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1
Sir Charles Gairdner Hospital
Perth, Western Australia, Australia, 6009