Urinary Tract InfectionsNCT05712434
Chlorhexidine to Prevent Catheter-related Urinary Tract Infection
A study testing Long Intervention, Mid-length Intervention and Short Intervention in people with Urinary Tract Infections, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
The study is to investigate whether chlorhexidine (CHG)-based antiseptics is more effective to prevent catheter-related urinary tract infection (CAUTI) among inhospital patients who required Foley catheter insertion. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Urinary Tract Infections
- What is being tested?
- Long Intervention, Mid-length Intervention and Short Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30,994 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Mar 2023to 30 Apr 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Adult acute care wards or intensive care units, which primarily care for adult patients aged above 18 years.
- Currently not using chlorhexidine as disinfectants for Foley catheter insertion or routine care.
- Had patients who required Foley catheter insertion during the last 12 months prior to inclusion.
- Willing to implant measures to improve the rate of CAUTI, and to participate and follow the study protocol in our study.
Who cannot join
- Units currently using chlorhexidine as disinfectants for Foley catheter insertion or routine care.
- Wards or intensive care units with patients aged below 18 years of age in their routine practice.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multi-center, Stepped-wedge, Cluster-randomized Control Trial to Evaluation the Effectiveness of Chlorhexidine to Prevent Catheter-associated Urinary Tract Infection
The study is to investigate whether chlorhexidine (CHG)-based antiseptics is more effective to prevent catheter-related urinary tract infection (CAUTI) among inhospital patients who required Foley catheter insertion. This is a cluster-randomised, step-wedged clinical trial, in which every participated unit will used three different Foley catheter insertion protocols during the study period:
- Iodine protocol: using 10% povidone-iodine as the primary antiseptic during Foley insertion. This is the routine practice before this study in the participated hospital, as well as many Taiwanese hospitals.
- CHG protocol: instead of povidone-iodine solution, use 2% aqueous CHG solution as the primary disinfectant during Foley solution.
- CHG plus protocol: additional to 2% CHG solution, added 0.5% CHG impregnated gel as the lubrication during Foley insertion.
Read the detailed description
This is a open-labelled, cluster-randomized, step-wedged clinical trial aimed to observe the incidence if CAUTI during the designated study period (12 months for all participated units). All included units will start with the iodine protocol, which is the standard practice in the hospital, and then switched to CHG protocol than CHG plus protocol according to the results of randomization. Each unit will be randomized in to three different groups (A, B, and C):
Group A) 2 months of iodine protocol, followed by 4 months of CHG protocol, followed by 6 months of CHG plus protocol.
Group B) 4 months of iodine protocol, followed by 4 months of CHG protocol, followed by 4 months of CHG plus protocol.
Group C) 6 months of iodine protocol, followed by 4 months of CHG protocol, followed by 2 months of CHG plus protocol.
All unit will be monitored and compared for the occurrence of CAUTI, which is defined in accordance to the definition from the National Healthcare Safety Network (USCDC).
- Conditions
- Urinary Tract Infections
- Being tested
- Long Intervention, Mid-length Intervention, Short Intervention
- Keywords
- chlorhexidine, catheter-related urinary tract infection, disinfection, bundle care, Foley catheter, urinary catheter
- Medical subject headings
- Urinary Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Long InterventionOther
Also called 4-month CHG and 6-month CHG plus
Each unit will start with iodine protocol, which uses 10% povidone-iodine for disinfection during Foley insertion, for 2 months. After the designated duration of protocol (determined by the results of randomization), each unit will than switched to CHG protocol for 4 months, in which 2% aqueous chlorhexidine solution are used instead of iodine solution. Subsequently, in the final 6-month phase of study, each unit will than switched to CHG plus protocol, in which 0.05% CHG impregnated gel will be used alongside 2% CHG solution during Foley insertion.
Mid-length InterventionOther
Also called 4-month CHG and 4-month CHG plus
Each unit will start with iodine protocol, which uses 10% povidone-iodine for disinfection during Foley insertion, for 4 months. After the designated duration of protocol (determined by the results of randomization), each unit will than switched to CHG protocol for 4 months, in which 2% aqueous chlorhexidine solution are used instead of iodine solution. Subsequently, in the final 4-month phase of study, each unit will than switched to CHG plus protocol, in which 0.05% CHG impregnated gel will be used alongside 2% CHG solution during Foley insertion.
Short InterventionOther
Also called 4-month CHG and 2-month CHG plus
Each unit will start with iodine protocol, which uses 10% povidone-iodine for disinfection during Foley insertion, for 6 months. After the designated duration of protocol (determined by the results of randomization), each unit will than switched to CHG protocol for 4 months, in which 2% aqueous chlorhexidine solution are used instead of iodine solution. Subsequently, in the final 2-month phase of study, each unit will than switched to CHG plus protocol, in which 0.05% CHG impregnated gel will be used alongside 2% CHG solution during Foley insertion.
| Study group | Role | What they receive |
|---|---|---|
| Long CHG Intervention | Experimental | 2 months of iodine protocol, followed by 4 months of CHG protocol, followed by 6 months of CHG plus protocol. Receives: Other: Long Intervention |
| Mid-length CHG Intervention | Experimental | 4 months of iodine protocol, followed by 4 months of CHG protocol, followed by 4 months of CHG plus protocol. Receives: Other: Mid-length Intervention |
| Short CHG Intervention | Experimental | 6 months of iodine protocol, followed by 4 months of CHG protocol, followed by 2 months of CHG plus protocol. Receives: Other: Short Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of catheter-related urinary tract infection
The incidence of CAUTI, according to the updated definition of National Healthcare Safety Network (any Candida species will be excluded as pathogen)
Measured: During the entire observation period (12 months)
Secondary outcomes (2)
Incidence of catheter-related urinary tract infection (including candiduria)
The incidence of CAUTI, according to the updated definition of National Healthcare Safety Network, but candiduria not excluded as pathogen
Measured: During the entire observation period (12 months)
Incidence of catheter-related urinary tract infection, by different clinical relevant isolates
The incidence of CAUTI caused by different clinical relevant isolates (Pseudomonas aeruginosa, enterococci, enteric gram-negative bacteria, other pseudomonads, etc.)
Measured: During the entire observation period (12 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2023
- Study start1 Mar 2023
- Primary completion31 Mar 2024
- Study completion30 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary Tract InfectionsStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- Each enrolled units will start with iodine protocol, and then switched to CHG protocol at designated time, followed by CHG plus protocol subsequently. Each unit will be randomized in to three different groups (A, B, and C): Group A) 2 months of iodine protocol, followed by 4 months of CHG protocol, followed by 6 months of CHG plus protocol. Group B) 4 months of iodine protocol, followed by 4 months of CHG protocol, followed by 4 months of CHG plus protocol. Group C) 6 months of iodine protocol, followed by 4 months of CHG protocol, followed by 2 months of CHG plus protocol.
- Masking
- None (open label)
- Enrolment
- 30,994 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Taiwan University Hospital, Yun-Lin Branch, Hualien Tzu Chi General Hospital, National Taiwan University Hospital Hsin-Chu Branch, Lotung Poh-Ai Hospital, Min-Sheng General Hospital
- Responsible party
- Sponsor
- Investigators
- Yee-Chun Chen, PhD, Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05712434
- Sponsor's protocol ID
- 202212030MIFA
- Status last verified
- Jan 2023
- First submitted
- 25 Jan 2023
- Last updated
- 8 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Owing to the study design, informed consent is waived by the Research Ethic Committee of National Taiwan University Hospital. Therefore, individual data could not be shared as there is no consent.
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Stepped-wedge, Cluster-randomized Control Trial to Evaluation the Effectiveness of Chlorhexidine to Prevent Catheter-associated Urinary Tract Infection
- ClinicalTrials.gov ID
- NCT05712434
- Acronym / sponsor ID
- 202212030MIFA
- Conditions
- Urinary Tract Infections
- Keywords
- chlorhexidine, catheter-related urinary tract infection, disinfection, bundle care, Foley catheter, urinary catheter
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30,994 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Collaborators
- National Taiwan University Hospital, Yun-Lin Branch, Hualien Tzu Chi General Hospital, National Taiwan University Hospital Hsin-Chu Branch, Lotung Poh-Ai Hospital, Min-Sheng General Hospital
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 31 Mar 2024 (actual)
- Study completion
- 30 Apr 2024 (actual)
- First posted
- 3 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study is to investigate whether chlorhexidine (CHG)-based antiseptics is more effective to prevent catheter-related urinary tract infection (CAUTI) among inhospital patients who required Foley catheter insertion. This is a cluster-randomised, step-wedged clinical trial, in which every participated unit will used three different Foley catheter insertion protocols during the study period:
- Iodine protocol: using 10% povidone-iodine as the primary antiseptic during Foley insertion. This is the routine practice before this study in the participated hospital, as well as many Taiwanese hospitals.
- CHG protocol: instead of povidone-iodine solution, use 2% aqueous CHG solution as the primary disinfectant during Foley solution.
- CHG plus protocol: additional to 2% CHG solution, added 0.5% CHG impregnated gel as the lubrication during Foley insertion.
Detailed description
This is a open-labelled, cluster-randomized, step-wedged clinical trial aimed to observe the incidence if CAUTI during the designated study period (12 months for all participated units). All included units will start with the iodine protocol, which is the standard practice in the hospital, and then switched to CHG protocol than CHG plus protocol according to the results of randomization. Each unit will be randomized in to three different groups (A, B, and C):
Group A) 2 months of iodine protocol, followed by 4 months of CHG protocol, followed by 6 months of CHG plus protocol.
Group B) 4 months of iodine protocol, followed by 4 months of CHG protocol, followed by 4 months of CHG plus protocol.
Group C) 6 months of iodine protocol, followed by 4 months of CHG protocol, followed by 2 months of CHG plus protocol.
All unit will be monitored and compared for the occurrence of CAUTI, which is defined in accordance to the definition from the National Healthcare Safety Network (USCDC).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Each enrolled units will start with iodine protocol, and then switched to CHG protocol at designated time, followed by CHG plus protocol subsequently. Each unit will be randomized in to three different groups (A, B, and C): Group A) 2 months of iodine protocol, followed by 4 months of CHG protocol, followed by 6 months of CHG plus protocol. Group B) 4 months of iodine protocol, followed by 4 months of CHG protocol, followed by 4 months of CHG plus protocol. Group C) 6 months of iodine protocol, followed by 4 months of CHG protocol, followed by 2 months of CHG plus protocol.
| Arm | Type | Receives |
|---|---|---|
| Long CHG Intervention | Experimental | Other: Long Intervention2 months of iodine protocol, followed by 4 months of CHG protocol, followed by 6 months of CHG plus protocol. |
| Mid-length CHG Intervention | Experimental | Other: Mid-length Intervention4 months of iodine protocol, followed by 4 months of CHG protocol, followed by 4 months of CHG plus protocol. |
| Short CHG Intervention | Experimental | Other: Short Intervention6 months of iodine protocol, followed by 4 months of CHG protocol, followed by 2 months of CHG plus protocol. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Adult acute care wards or intensive care units, which primarily care for adult patients aged above 18 years.
- Currently not using chlorhexidine as disinfectants for Foley catheter insertion or routine care.
- Had patients who required Foley catheter insertion during the last 12 months prior to inclusion.
- Willing to implant measures to improve the rate of CAUTI, and to participate and follow the study protocol in our study.
Key exclusion criteria (2 listed)
- Units currently using chlorhexidine as disinfectants for Foley catheter insertion or routine care.
- Wards or intensive care units with patients aged below 18 years of age in their routine practice.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Long InterventionAlso: 4-month CHG and 6-month CHG plusEach unit will start with iodine protocol, which uses 10% povidone-iodine for disinfection during Foley insertion, for 2 months. After the designated duration of protocol (determined by the results of randomization), each unit will than switched to CHG protocol for 4 months, in which 2% aqueous chlorhexidine solution are used instead of iodine solution. Subsequently, in the final 6-month phase of study, each unit will than switched to CHG plus protocol, in which 0.05% CHG impregnated gel will be used alongside 2% CHG solution during Foley insertion. | Other | Long CHG Intervention |
| Mid-length InterventionAlso: 4-month CHG and 4-month CHG plusEach unit will start with iodine protocol, which uses 10% povidone-iodine for disinfection during Foley insertion, for 4 months. After the designated duration of protocol (determined by the results of randomization), each unit will than switched to CHG protocol for 4 months, in which 2% aqueous chlorhexidine solution are used instead of iodine solution. Subsequently, in the final 4-month phase of study, each unit will than switched to CHG plus protocol, in which 0.05% CHG impregnated gel will be used alongside 2% CHG solution during Foley insertion. | Other | Mid-length CHG Intervention |
| Short InterventionAlso: 4-month CHG and 2-month CHG plusEach unit will start with iodine protocol, which uses 10% povidone-iodine for disinfection during Foley insertion, for 6 months. After the designated duration of protocol (determined by the results of randomization), each unit will than switched to CHG protocol for 4 months, in which 2% aqueous chlorhexidine solution are used instead of iodine solution. Subsequently, in the final 2-month phase of study, each unit will than switched to CHG plus protocol, in which 0.05% CHG impregnated gel will be used alongside 2% CHG solution during Foley insertion. | Other | Short CHG Intervention |
Primary outcome
Incidence of catheter-related urinary tract infection
Time frame: During the entire observation period (12 months)
The incidence of CAUTI, according to the updated definition of National Healthcare Safety Network (any Candida species will be excluded as pathogen)
2 secondary outcomes
Incidence of catheter-related urinary tract infection (including candiduria)
Time frame: During the entire observation period (12 months)
Incidence of catheter-related urinary tract infection, by different clinical relevant isolates
Time frame: During the entire observation period (12 months)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2024.
- Individual participant dataSharing planned: No. Owing to the study design, informed consent is waived by the Research Ethic Committee of National Taiwan University Hospital. Therefore, individual data could not be shared as there is no consent.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yee-Chun Chen, PhD principal investigator
National Taiwan University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Long Intervention, Mid-length Intervention and Short Intervention in people with Urinary Tract Infections, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of catheter-related urinary tract infection (time frame: During the entire observation period (12 months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2024.