Chlorhexidine to Prevent Catheter-related Urinary Tract Infection

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:

1. 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.
2. CHG protocol: instead of povidone-iodine solution, use 2% aqueous CHG solution as the primary disinfectant during Foley solution.
3. CHG plus protocol: additional to 2% CHG solution, added 0.5% CHG impregnated gel as the lubrication during Foley insertion.

Study Overview

• Status: Recruiting
• Conditions: Urinary Tract Infections
• Intervention / Treatment: Other: Long Intervention; Other: Mid-length Intervention; Other: Short Intervention

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 Type: Interventional
• Enrollment (Anticipated): 15000
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Taipei, Taiwan, 100
    • Recruiting
    • National Taiwan University Hospital
    • Contact: Guan-Jhou Chen, MD, MSc; Email: guanjhouchen@ntu.edu.tw

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Long CHG Intervention; 2 months of iodine protocol, followed by 4 months of CHG protocol, followed by 6 months of CHG plus protocol.	Other: Long Intervention; 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.; Other Names: 4-month CHG and 6-month CHG plus
Experimental: Mid-length CHG Intervention; 4 months of iodine protocol, followed by 4 months of CHG protocol, followed by 4 months of CHG plus protocol.	Other: Mid-length Intervention; 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.; Other Names: 4-month CHG and 4-month CHG plus
Experimental: Short CHG Intervention; 6 months of iodine protocol, followed by 4 months of CHG protocol, followed by 2 months of CHG plus protocol.	Other: Short Intervention; 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.; Other Names: 4-month CHG and 2-month CHG plus

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	During the entire observation period (12 months)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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.)	During the entire observation period (12 months)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
The occurrence of severe adverse effects related to topical CHG disinfection	The occurrence of severe adverse effects related to topical CHG disinfection	During the entire observation period (12 months)

Collaborators and Investigators

• Sponsor: National Taiwan University Hospital
• Collaborators: Min-Sheng General Hospital; Lotung Poh-Ai Hospital; Hualien Tzu Chi General Hospital; National Taiwan University Hospital Hsin-Chu Branch; National Taiwan University Hospital, Yun-Lin Branch

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2023
• Primary Completion (Anticipated): March 31, 2024
• Study Completion (Anticipated): March 31, 2024

Study Registration Dates

• First Submitted: January 25, 2023
• First Submitted That Met QC Criteria: January 25, 2023
• First Posted (Actual): February 3, 2023

Study Record Updates

• Last Update Posted (Estimate): May 5, 2023
• Last Update Submitted That Met QC Criteria: May 4, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Keywords: chlorhexidine; Foley catheter; urinary catheter; catheter-related urinary tract infection; disinfection; bundle care
• Additional Relevant MeSH Terms: Pathologic Processes; Urologic Diseases; Disease Attributes; Infections; Communicable Diseases; Urinary Tract Infections
• Other Study ID Numbers: 202212030MIFA

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD 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.

Drug and device information, study documents

• 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