Nasal Tea Tree Oil for the Prevention of Infections in PD Patients
Condition: End Stage Renal Failure on Dialysis
MeSH terms: Kidney Failure, Chronic
Intervention: 5% tea tree oil nasal ointment
Intervention description: daily for 5 days then weekly for 6 months
Intervention MeSH terms: Tea Tree Oil
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 5.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: haemodialysis; peritoneal dialysis

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
    

Eligibility criteria:

        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

        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