Trial Outcomes & Findings for Nasal Tea Tree Oil for the Prevention of Infections in PD Patients (NCT NCT01214395)

NCT ID: NCT01214395

Last Updated: 2012-08-03

Results Overview

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

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 5 participants
• Primary outcome timeframe: 6 months
• Results posted on: 2012-08-03

Participant Flow

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.

All enrolled patients participated in the trial.

Participant milestones

Measure	Tea Tree Oil Application tea tree oil medication group
Overall Study STARTED	5
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	5

Reasons for withdrawal

Measure	Tea Tree Oil Application tea tree oil medication group
Overall Study All patients had infection	5

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Tea Tree Oil Application n=5 Participants tea tree oil medication group
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	5 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants
Region of Enrollment Australia	5 participants n=5 Participants

PRIMARY outcome

Timeframe: 6 months

Catheter-related infections will be defined according to standard guidelines

Cases with "definite" and "probable" infections will be classified as infections.

Outcome measures

Measure	Tea Tree Oil n=5 Participants tea tree oil application
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.	0 participants

SECONDARY outcome

Timeframe: 6 months

Population: counted

Outcome measures

Measure	Tea Tree Oil n=5 Participants tea tree oil application
The Number of Patients That Did Not Have a Staphylococcus Aureus Infection	3 participants

Adverse Events

Tea Tree Oil Application

Serious events: 2 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Tea Tree Oil Application n=5 participants at risk tea tree oil medication group
Renal and urinary disorders peritonitis	40.0% 2/5 • Number of events 2 • 26 weeks

Other adverse events

Adverse event data not reported

Additional Information

Dr Kerry Carson Trial Manager

PathWest Laboratory Medicine WA

Phone: +61 8 93464092

Email: kerry.carson@uwa.edu.au

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place