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

End Stage Renal Failure on Dialysis Clinical Trial

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

Status Completed

Clinical Trial 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

Clinical Trial 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

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• End Stage Renal Failure on Dialysis
• Kidney Failure, Chronic

• NCT number: NCT01214395
• Study type: Interventional
• Source: PathWest Laboratory Medicine WA
• Status: Completed
• Phase: Phase 2
• Start date: June 2010
• Completion date: December 2011