Clinical trial NCT01214395: Nasal Tea Tree Oil for the Prevention of Infections in PD Patients
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: End Stage Renal Failure on Dialysis
Keywords: haemodialysis
peritoneal dialysis
Lead sponsor: PathWest Laboratory Medicine WA
Sponsor class: OTHER_GOV
First posted: 2010-10-05
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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 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

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.

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

Primary outcomes:
measure: 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.
timeFrame: 6 months
Secondary outcomes:
measure: The Number of Patients That Did Not Have a Staphylococcus Aureus Infection
timeFrame: 6 months
Other outcomes:
Locations:
city: Perth
country: Australia
facility: Sir Charles Gairdner Hospital
state: Western Australia
Study officials:
affiliation: Sir Charles Gairdner Hospital
name: Brian Hutchison, MBBS
role: PRINCIPAL_INVESTIGATOR
References: