Nasal Tea Tree Oil for the Prevention of Infections in PD Patients

• Status: Completed
• Trial end date: 2011-12-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: PathWest Laboratory Medicine WA
• Treatments: Tea Tree Oil

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