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

June 22, 2012 updated by: Kerry Carson, PathWest Laboratory Medicine WA

An Investigator Blinded Controlled Study of the Nasal Application of 5% Tea Tree Oil (TTO) for the Prevention of Catheter-associated Infections in Renal Dialysis Patients

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

Study Overview

Status

Completed

Conditions

End Stage Renal Failure on Dialysis

Intervention / Treatment

Drug: 5% tea tree oil nasal ointment

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 prescription for 5% TTO nasal ointment which was filled by the SCGH pharmacy. The application of medication will follow the usual procedure which consists of bi-daily nasal application for 5 days and then weekly application for the next 25 weeks of the trial. The patients are not blinded and are given all their medication at one dispensing which consists of 3 × 10 g tubes of 5% TTO. The patients have weekly assessments for the first 6 weeks of the trial and then 4 weekly assessments until week 26. All assessments are conducted during routine dressing changes or routine visits and are conducted by specially trained dialysis nurses. During each visit the catheter site is examined for any signs of infection and the findings documented on a questionnaire. Suspected cases of infection are identified by trained nurses and the consultant physician will then examined the patient. The findings will be documented by the nurse on a questionnaire and submitted to the primary investigator for review, confirmation, and classification. The primary endpoint is the proportion of patients with a catheter-related infection within 6 months after entry into the study. The infections included: (1) exit site infection (ESI); (2) tunnel infections; and (3) bacteraemia. The endpoint is evaluated by the primary investigator according to the definitions for catheter-related infections. Cases with "definite" and "probable" infections will be classified as infections.

All catheter-related infections are treated by the patient's nephrologist according to their usual practice. If a new catheter is clinically indicated, the patient will continued to receive the same ointment to which they had been assigned. Swabs for cultures and sensitivities at the catheter exit site are taken if an exit or tunnel infection is suspected and blood cultures if a bacteraemia is suspected. All microbiology samples will be sent to the PathWest laboratory for culture and sensitivities. The study will end when the last enrolled subject has completed the minimum 6-month study period.

Study Type

Interventional

Enrollment (Actual)

Phase

Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Australia
- Western Australia
  - Perth, Western Australia, Australia, 6009
    - Sir Charles Gairdner Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: PREVENTION
Allocation: NA
Interventional Model: SINGLE_GROUP
Masking: NONE

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Primary Endpoint Will be the Number of Tea Tree Oil Patients That Did Not Have a Catheter-related Infection Within 6 Months After Entry Into the Trial. Time Frame: 6 months	Catheter-related infections will be defined according to standard guidelines Cases with "definite" and "probable" infections will be classified as infections.	6 months

Secondary Outcome Measures

Outcome Measure	Time Frame
The Number of Patients That Did Not Have a Staphylococcus Aureus Infection Time Frame: 6 months	6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

PathWest Laboratory Medicine WA

Investigators

Principal Investigator: Brian Hutchison, MBBS, Sir Charles Gairdner Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2010

Primary Completion (ACTUAL)

November 1, 2011

Study Completion (ACTUAL)

December 1, 2011

Study Registration Dates

First Submitted

October 4, 2010

First Submitted That Met QC Criteria