This study will compare the use of tea tree oil against mupirocin as a topical nasal antiseptic to see which is best at preventing infections in patients that need renal dialysis. Fifty subjects will be recruited into each arm of the trial 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.
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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Prevention
Primary Outcome Measures:
- Primary endpoint will be the proportion of tea tree oil and mupirocin patients that have a catheter-related infection within 6 months after entry into the trial. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- Catheter-related infections will be defined according to standard guidelines.
- Cases with “definite” and “probable” infections will be classified as infections.
Secondary Outcome Measures:
- Secondary endpoints will be infection-free survival, survival probabilities and estimated mean survival times. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- These will be generated according to the Kaplan-Meier method. Differences in the survival curves between the two groups will be evaluated using the log rank test.
5% tea tree oil: Experimental intervention: Drug: tea tree oil.
Mupirocin (Bactroban):Active Comparator
– Drug: Bactroban
– Drug: tea tree oil
Drug: tea tree oil
5% tea tree oil ointment, nasal application, twice daily 5 days then weekly for 6 months
Drug: Bactroban nasal application, twice daily 5 days then weekly for 6 months
June 2010 – December 2011
Eligibility & Criteria
Ages Eligible for Study: 18 Years to 80 Years
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No
- 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 of either haemodialysis or peritoneal dialysis
- known sensitivity to TTO
- Use of mediated and non-medicated nasal ointments in the past 12 weeks
- HD patients likely to transfer to 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 hepatitis 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
Jon Hosking, B. Nursing
+61 9346 2806
Kerry Carson, PhD
+61 8 9346 4092