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Chlorhexidine to Prevent Catheter-related Urinary Tract Infection

Primary Purpose

Urinary Tract Infections

Status
Recruiting
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Long Intervention
Mid-length Intervention
Short Intervention
Sponsored by
National Taiwan University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Urinary Tract Infections focused on measuring chlorhexidine, catheter-related urinary tract infection, disinfection, bundle care, Foley catheter, urinary catheter

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

This is a cluster-randomized clinical trial. The enrollment is for healthcare units (wards, ICUs) in the participated hospitals rather than individuals. Patients who were admitted in the included unit with be enrolled in our study automatically. Inclusion Criteria (for units): 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. Exclusion Criteria (for units): 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.

Sites / Locations

  • National Taiwan University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Long CHG Intervention

Mid-length CHG Intervention

Short CHG Intervention

Arm Description

2 months of iodine protocol, followed by 4 months of CHG protocol, followed by 6 months of CHG plus protocol.

4 months of iodine protocol, followed by 4 months of CHG protocol, followed by 4 months of CHG plus protocol.

6 months of iodine protocol, followed by 4 months of CHG protocol, followed by 2 months of CHG plus protocol.

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

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
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.)

Full Information

First Posted
January 25, 2023
Last Updated
May 4, 2023
Sponsor
National Taiwan University Hospital
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
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1. Study Identification

Unique Protocol Identification Number
NCT05712434
Brief Title
Chlorhexidine to Prevent Catheter-related Urinary Tract Infection
Official Title
A Multi-center, Stepped-wedge, Cluster-randomized Control Trial to Evaluation the Effectiveness of Chlorhexidine to Prevent Catheter-associated Urinary Tract Infection
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 1, 2023 (Actual)
Primary Completion Date
March 31, 2024 (Anticipated)
Study Completion Date
March 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Taiwan University Hospital
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

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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. 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Tract Infections
Keywords
chlorhexidine, catheter-related urinary tract infection, disinfection, bundle care, Foley catheter, urinary catheter

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
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)
Allocation
Randomized
Enrollment
15000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Long CHG Intervention
Arm Type
Experimental
Arm Description
2 months of iodine protocol, followed by 4 months of CHG protocol, followed by 6 months of CHG plus protocol.
Arm Title
Mid-length CHG Intervention
Arm Type
Experimental
Arm Description
4 months of iodine protocol, followed by 4 months of CHG protocol, followed by 4 months of CHG plus protocol.
Arm Title
Short CHG Intervention
Arm Type
Experimental
Arm Description
6 months of iodine protocol, followed by 4 months of CHG protocol, followed by 2 months of CHG plus protocol.
Intervention Type
Other
Intervention Name(s)
Long Intervention
Other Intervention Name(s)
4-month CHG and 6-month CHG plus
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Mid-length Intervention
Other Intervention Name(s)
4-month CHG and 4-month CHG plus
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Short Intervention
Other Intervention Name(s)
4-month CHG and 2-month CHG plus
Intervention Description
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.
Primary Outcome Measure Information:
Title
Incidence of catheter-related urinary tract infection
Description
The incidence of CAUTI, according to the updated definition of National Healthcare Safety Network (any Candida species will be excluded as pathogen)
Time Frame
During the entire observation period (12 months)
Secondary Outcome Measure Information:
Title
Incidence of catheter-related urinary tract infection (including candiduria)
Description
The incidence of CAUTI, according to the updated definition of National Healthcare Safety Network, but candiduria not excluded as pathogen
Time Frame
During the entire observation period (12 months)
Title
Incidence of catheter-related urinary tract infection, by different clinical relevant isolates
Description
The incidence of CAUTI caused by different clinical relevant isolates (Pseudomonas aeruginosa, enterococci, enteric gram-negative bacteria, other pseudomonads, etc.)
Time Frame
During the entire observation period (12 months)
Other Pre-specified Outcome Measures:
Title
The occurrence of severe adverse effects related to topical CHG disinfection
Description
The occurrence of severe adverse effects related to topical CHG disinfection
Time Frame
During the entire observation period (12 months)

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
This is a cluster-randomized clinical trial. The enrollment is for healthcare units (wards, ICUs) in the participated hospitals rather than individuals. Patients who were admitted in the included unit with be enrolled in our study automatically. Inclusion Criteria (for units): 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. Exclusion Criteria (for units): 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Guan-Jhou Chen, MD, MSc
Phone
+886-3-3179599
Ext
2070
Email
guanjhouchen@ntu.edu.tw
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yee-Chun Chen, PhD
Organizational Affiliation
National Taiwan University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Taiwan University Hospital
City
Taipei
ZIP/Postal Code
100
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Guan-Jhou Chen, MD, MSc
Email
guanjhouchen@ntu.edu.tw

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
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.

Learn more about this trial

Chlorhexidine to Prevent Catheter-related Urinary Tract Infection

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