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

• Sponsor: PathWest Laboratory Medicine WA (Other)
• Overall Status: Completed
• CT.gov ID: NCT01214395
• Collaborator: (none)
• Enrollment: 5
• Location: 1
• Duration (Months): 18
• Patients Per Site Per Month: 0.3

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
End Stage Renal Failure on Dialysis	Drug: 5% tea tree oil nasal ointment	Phase 2

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 Design

• Study Type: Interventional
• Actual Enrollment: 5 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• 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 Start Date: Jun 1, 2010
• Actual Primary Completion Date: Nov 1, 2011
• Actual Study Completion Date: Dec 1, 2011

Outcome Measures

Primary Outcome Measures

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. [6 months]

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

Secondary Outcome Measures

1. The Number of Patients That Did Not Have a Staphylococcus Aureus Infection [6 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Sir Charles Gairdner Hospital	Perth	Western Australia	Australia	6009

Sponsors and Collaborators

• PathWest Laboratory Medicine WA

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Kerry Carson, Co-Investigator, PathWest Laboratory Medicine WA
• ClinicalTrials.gov Identifier: NCT01214395
• Other Study ID Numbers: 2006-199
• First Posted: Oct 5, 2010
• Last Update Posted: Aug 3, 2012
• Last Verified: Jun 1, 2012

• Keywords provided by Kerry Carson, Co-Investigator, PathWest Laboratory Medicine WA: haemodialysis; peritoneal dialysis
• Additional relevant MeSH terms: Kidney Failure, Chronic; Tea Tree Oil

Study Results

Participant Flow

Recruitment Details	Recruitment was from the Renal Unit at Sir Charles Gairdner Hospital and was conducted by the nursing staff in that ward. The recruitment period was from 1 July 2010-30 June 2011.
Pre-assignment Detail	All enrolled patients participated in the trial.

Arm/Group Title	Tea Tree Oil Application
Arm/Group Description	tea tree oil medication group
Period Title: Overall Study
STARTED	5
COMPLETED	0
NOT COMPLETED	5

Baseline Characteristics

Arm/Group Title	Tea Tree Oil Application
Arm/Group Description	tea tree oil medication group
Overall Participants	5
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	5 100%
>=65 years	0 0%
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	5 100%
>=65 years	0 0%
Sex: Female, Male (Count of Participants)
Female	2 40%
Male	3 60%
Region of Enrollment (participants) [Number]
Australia	5 100%

Outcome Measures

1. Primary Outcome

Title	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.
Description	Catheter-related infections will be defined according to standard guidelines Cases with "definite" and "probable" infections will be classified as infections.
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Tea Tree Oil
Arm/Group Description	tea tree oil application
Measure Participants	5
Number [participants]	0 0%

2. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

counted

Arm/Group Title	Did Not Have Staph. Aureus Infection
Arm/Group Description	No exit site infection or peritonitis with Staph. aureus
Measure Participants	5
Number [participants]	3 60%

Adverse Events

Time Frame	26 weeks
Arm/Group Title	Tea Tree Oil Application
Arm/Group Description	tea tree oil medication group
All Cause Mortality
	Tea Tree Oil Application
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Tea Tree Oil Application
	Affected / at Risk (%)	# Events
Total	2/5 (40%)
Renal and urinary disorders
peritonitis	2/5 (40%)	2
Other (Not Including Serious) Adverse Events
	Tea Tree Oil Application
	Affected / at Risk (%)	# Events
Total	0/5 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.