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

NCT01214395 | Completed Phase 2 Results

• 1 other identifier: 2006-199
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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

Conditions

End Stage Renal Failure on Dialysis

Keywords

haemodialysis; peritoneal dialysis

Outcome Measures

Primary Outcomes (1)

• 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.

  Catheter-related infections will be defined according to standard guidelines Cases with "definite" and "probable" infections will be classified as infections.

  6 months

Secondary Outcomes (1)

• The Number of Patients That Did Not Have a Staphylococcus Aureus Infection

  6 months

Interventions

5% tea tree oil nasal ointment DRUG

daily for 5 days then weekly for 6 months

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• PathWest Laboratory Medicine WA: lead

Study Sites (1)

Sir Charles Gairdner Hospital

Perth, Western Australia, 6009, Australia

Location

Results Point of Contact

• Title: Dr Kerry Carson Trial Manager
• Organization: PathWest Laboratory Medicine WA

kerry.carson@uwa.edu.au

+61 8 93464092

Study Officials

• Brian Hutchison, MBBS

  Sir Charles Gairdner Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Co-Investigator

Study Record Dates

• First Submitted: October 4, 2010
• First Posted: October 5, 2010
• Study Start: June 1, 2010
• Primary Completion: November 1, 2011
• Study Completion: December 1, 2011
• Last Updated: August 3, 2012
• Results First Posted: August 3, 2012

Record last verified: 2012-06

Locations

AU (1)