Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000278437
Ethics application status
Approved
Date submitted
31/03/2025
Date registered
11/04/2025
Date last updated
11/04/2025
Date data sharing statement initially provided
11/04/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Effect of chlorhexidine 0.1% wipes on catheter associated urinary tract infections: a double-blind randomised control trial
Scientific title
Effect of chlorhexidine 0.1% wipes on catheter associated urinary tract infections in adult inpatients: a double-blind randomised control trial
Secondary ID [1] 314088 0
None
Universal Trial Number (UTN)
Trial acronym
CATION 2.0
Linked study record

Health condition
Health condition(s) or problem(s) studied:
urinary tract infection 336857 0
catheter associated urinary tract infection 336858 0
Condition category
Condition code
Infection 333333 333333 0 0
Studies of infection and infectious agents
Public Health 333334 333334 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention is the use of a sterile wipe, containing 0.1% chlorhexidine solution, for meatal cleaning prior to urinary catheter insertion. The intervention will be delivered by a specific staff member or members at the hospital.
A single wipe will be used once, for the cleaning process, which should take approximately 15 seconds.
The intervention will be administrated by a registered nurse or medical doctor.
Adherence will be monitored through audits of medical records.
Intervention code [1] 330663 0
Prevention
Comparator / control treatment
The control is the use of a sterile wipe, containing 0.9% normal saline, for meatal cleaning prior to urinary catheter insertion.
Control group
Placebo

Outcomes
Primary outcome [1] 340908 0
Proportion of participants with a catheter associated urinary tract infection.
Timepoint [1] 340908 0
The outcome will be evaluated at the end of the trial i.e. 8 months.
Secondary outcome [1] 445423 0
The proportion of participants with catheter-associated asymptomatic bacteriuria
Timepoint [1] 445423 0
The outcome will be evaluated at the end of the trial i.e. 8 months.
Secondary outcome [2] 445424 0
The time in days to first catheter associated urinary traction infection
Timepoint [2] 445424 0
The outcome will be evaluated at the end of the trial i.e. 8 months.

Eligibility
Key inclusion criteria
- inpatients in the enrolled hospital
- 18 years of age and over
- persons receiving an indwelling urinary catheter as determined as part of their usual medical care.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- under 18 years of age
- an allergy, contraindication or other medical reason preventing the use of the intervention for cleaning the urethral meatal area
- those who require in-and-out or suprapubic catheterisation
- those with symptoms and signs suggestive of UTI and patients already undergoing treatment for UTI.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Following randomisation, the allocation of participant to groups will be restricted to a password protected file, only accessible by one researcher. Data on allocation will only accessible by one researcher not involved with data collection.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants will be randomised (double-blind) in a 1:1 ratio and allocated to either a usual care followed by intervention or intervention followed by usual care. Randomisation and blinding will be coordinated by a researcher not involved with data collection, through computer generated randomisation by another researcher not involved in data collection.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The dependent variable for analysis will be a confirmed catheter associated urinary tract infection (CAUTI) within 7 days of catheter insertion (No, Yes). Descriptive analysis will present observed proportions for the control and intervention condition, unadjusted for clustering by hospital. Data will be analysed by logistic regression to estimate the odds of CAUTI within 7 days of catheter insertion associated with the intervention condition, compared with the control condition. The model specification will include a binary fixed effect for the intervention and a fixed effect for each hospital (strata). Model results will provide information about the marginal difference in proportions as point estimates with bootstrapped 95% confidence intervals. The null hypothesis is that CAUTI proportions are equal between control and intervention arms, which will be tested against a two-sided alternative hypothesis. Statistical significance will be defined a p-value < 0.05.

Secondary outcomes:

The analysis will follow the same steps as per the primary outcome for catheter-associated asymptomatic bacteriura.

Time to first CAUTI will be described using Kaplan-Meier survival curves. A log-rank (Mantell- Cox) test will be used to compare survival distributions for control and intervention arms. A Cox proportional hazard model will be developed to estimate the hazard of CAUTI (yes or no), comparing those in the control and intervention arms. The proposed null hypothesis is that use of chlorhexidine 0.1% will not increase the hazard of a CAUTI compared to saline 0.9%. Hazard ratio will be adjusted for age, sex, and other clinically relevant patient characteristics assessed at baseline.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
4/08/2025
Actual
Date of last participant enrolment
Anticipated
23/06/2026
Actual
Date of last data collection
Anticipated
30/06/2026
Actual
Sample size
Target
1200
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD

Funding & Sponsors
Funding source category [1] 318595 0
Government body
Name [1] 318595 0
NHMRC
Country [1] 318595 0
Australia
Primary sponsor type
University
Name
Avondale University
Address
Country
Australia
Secondary sponsor category [1] 320996 0
None
Name [1] 320996 0
None
Address [1] 320996 0
Country [1] 320996 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 317196 0
Hunter New England Human Research Ethics Committee
Ethics committee address [1] 317196 0
Ethics committee country [1] 317196 0
Australia
Date submitted for ethics approval [1] 317196 0
30/01/2025
Approval date [1] 317196 0
18/02/2025
Ethics approval number [1] 317196 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 140310 0
Prof Brett Mitchell
Address 140310 0
Avondale University, School of Nursing and Health, 582 Freemans Drive Cooranbong NSW 2265
Country 140310 0
Australia
Phone 140310 0
+61 249802213
Fax 140310 0
Email 140310 0
[email protected]
Contact person for public queries
Name 140311 0
Brett Mitchell
Address 140311 0
Avondale University, School of Nursing and Health, 582 Freemans Drive Cooranbong NSW 2265
Country 140311 0
Australia
Phone 140311 0
+61 249802213
Fax 140311 0
Email 140311 0
[email protected]
Contact person for scientific queries
Name 140312 0
Brett Mitchell
Address 140312 0
Avondale University, School of Nursing and Health, 582 Freemans Drive Cooranbong NSW 2265
Country 140312 0
Australia
Phone 140312 0
+61 249802213
Fax 140312 0
Email 140312 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No
No IPD sharing reason/comment: To protect the privacy of participants no individual participant data will be made available.



What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.