A randomized controlled trial of tea tree oil (5%) body wash versus standard body wash to prevent colonization with methicillin-resistant Staphylococcus aureus (MRSA) in critically ill adults - Effectiveness of tea tree oil in preventing colonization with MRSA

Phase 1

• Conditions: Colonization with methicillin-resistant Staphylococcus aureus (MRSA)

• Registration Number: EUCTR2007-002853-21-GB
• Lead Sponsor: Belfast Health & Social Care Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2007-08-01
• Study Completion: 2009-08-17
• Last Update Posted: 10 December 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 1080

Inclusion Criteria

Patients admitted to the Regional Intensive Care Unit at the Belfast Health & Social Care Trust (Royal Victoria Hospital, Belfast) and the Intensive Care Unit at the South Eastern Health & social Care Trust (Ulster Hospital, Dundonald) during the study period will be eligible for inclusion in the study
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.Age < 18 years.
2.Those patients who are known to be colonized at the time of admission.
3.Patients who on admission are unlikely to remain in the ICU for at least 48 hours.
4.Patients who are recruited, whose pre-intervention MRSA screening tests are subsequently found to be positive will be withdrawn from the study.
5. Consent declined.
6. Known sensitivity to TTO.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> Main Objective: The hypothesis of the study is that treatment with tea tree oil (Novabac) can prevent colonisation with MRSA in critically ill adults.<br><br> The primary outcome is the incidence of new MRSA colonization.<br><br> ;<br> Secondary Objective: The secondary objectives are to<br><br> 1) investigate if treatment with tea tree oil is more cost-effective than standard body wash (Johnston’s softwash).<br> 2) investigate if the is no difference in sensitivity and specificity between a PCR-based assay for detection of colonization with MRSA and the standard culture method.<br> ;Primary end point(s): The primary outcome measure will be MRSA colonization at ICU discharge, measured using standard culture techniques