REPLACE: The Impact of Catheter Replacement in Patients With Catheter-associated Urinary Tract Infection

REPLACE: the Impact of Catheter Replacement in Patients With Catheter-associated Urinary Tract Infection

With this project the investigators aim to address the following question: "Is it beneficial to change bladder catheters during urinary tract infections?" There is debate regarding the usefulness of changing an indwelling catheter during antibiotic treatment of a catheter-associated urinary tract infection (CAUTI). The current guideline recommends catheter replacement, but is based on limited evidence. Our hypothesis is that there is no added value for patients to change the catheter during an antibiotic treatment for CAUTI. If refraining from catheter replacement is non inferior, this would result in a reduction of invasive procedures and reduction of healthcare associated costs. Patients with CAUTI and an indication for antibiotic treatment will be randomized to catheter replacement or no catheter replacement. The study will be conducted in academic and non-academic hospitals in The Netherlands. 300 patients will need to be included.

Study Overview

• Status: Recruiting
• Conditions: Catheter Associated Urinary Tract Infection
• Intervention / Treatment: Procedure: Catheter replacement; Procedure: Catheter retainment

Detailed Description

As a result of the widespread application of urinary catheterization, catheter-associated urinary tract infection (CAUTI) is the most common healthcare associated infection. To fasten recovery and reduce the risk of a recurrent CAUTI, current guidelines recommend to replace the catheter at the onset of a CAUTI when the indwelling catheter has been in place for more than 2 weeks. This recommendation, however, is based on limited evidence. Additionally, there is significant practice variation in the Netherlands regarding catheter replacement in CAUTI. Given the limited evidence and significant practice variation in the Netherlands, this Randomized Controlled Trial including 300 CAUTI patients is needed.

The main question this study aims to answer is whether not changing the urinary catheter (catheter retainment) during a catheter-associated urinary tract infection (CAUTI) is non-inferior to catheter replacement in terms of the risk of a recurrent CAUTI within 90 days. Secondary objectives include 30-day mortality, health-related quality of life, time to resolution of CAUTI symptoms, complications of catheter replacement (e.g., discomfort, bleeding, sepsis) and healthcare and societal costs.

In the intervention group there will be no catheter replacement during CAUTI, meaning there will be no catheter replacement during the entire course of antibiotic treatment. In this group, catheter replacement will follow the patients regular replacement schedule, consequently meaning that it occurs outside the duration of the antibiotic treatment . The duration of antibiotic treatment is 10 days for both men and women. The control group follows the current guidelines. In this group, the catheter will be replaced within 3 days after the start of antibiotic therapy.

• Study Type: Interventional
• Enrollment (Estimated): 300
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Eline C. Schippers; Phone Number: +31 (0) 6 22776467; Email: replace@lumc.nl

Study Locations

• Netherlands
  • Zuid-Holland
    • Leiden, Zuid-Holland, Netherlands, 2333 ZG
      • Recruiting
      • Leiden University Medical Center

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

1. Aged 18 years or older.
2. An indwelling catheter, either a transurethral or suprapubic catheter, that has been in place for at least 2 weeks.
3. At least one CAUTI-related symptom, defined according to the IDSA guideline (11): onset or worsening of fever (> 38 degrees), rigors, altered mental status, malaise or lethargy with no other identified cause, flank pain, costovertebral angle tenderness, acute haematuria, pelvic discomfort, or suprapubic pain/tenderness. In patients with spinal cord injury, increased spasticity, autonomic dysreflexia, or sense of unease are also compatible with CAUTI.
4. Urine culture with ≥ 103 colony-forming units (CFU)/mL of ≥ 1 bacterial species, or urine culture with <103 CFU/mL along with a positive blood culture with the same microorganism as the urine culture.
5. The ability to provide written informed consent for the use of their data.
6. Sufficient proficiency in the Dutch or English language, both spoken and written, to effectively communicate with the research team and accurately complete the questionnaires.

Exclusion Criteria:

1. Having an immunodeficiency: High-dose corticosteroid use (any equivalent of ≥ 20 mg prednisolone per day for > 4 weeks), severe primary immunodeficiency, organ transplant, neutropenia (absolute neutrophil count < 0.50 x 10⁹/L)
2. Expiration of the indication of the indwelling catheter.
3. Having a planned (routine) catheter replacement during antibiotic therapy.
4. Contraindications for catheter replacement (judgement treating physician)
5. Kidney catheters (nephrostomy or double-J catheter).
6. Needing bladder irrigations because of gross haematuria.
7. Having bladder stones.
8. Female patients who are pregnant.
9. Having a life expectancy of < 3 months.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Catheter replacement; The control group undergoes catheter replacement within 3 days of starting antibiotic therapy. Choice of antibiotic agent follows standard care guidelines, with adjustments based on culture results.	Procedure: Catheter replacement; In the intervention group, the catheter is not replaced during CAUTI treatment. Choice of antibiotic agent follows standard care guidelines, with adjustments based on culture results. In this group, catheter replacement occurs according to the patient's regular schedule. The control group undergoes catheter replacement within 3 days of starting antibiotic therapy. Choice of antibiotic agent follows standard care guidelines, with adjustments based on culture results.
Experimental: Catheter retainment; In the intervention group, the catheter is not replaced during CAUTI treatment. Choice of antibiotic agent follows standard careguidelines, with adjustments based on culture results. In this group, catheter replacement occurs according to the patient's regular schedule.	Procedure: Catheter retainment; In the intervention group, the catheter is not replaced during CAUTI treatment. Choice of antibiotic agent follows standard care guidelines, with adjustments based on culture results. In this group, catheter replacement occurs according to the patient's regular schedule. The control group undergoes catheter replacement within 3 days of starting antibiotic therapy. Choice of antibiotic agent follows standard care guidelines, with adjustments based on culture results.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recurrent CAUTI within 90 days post-antibiotic treatment (T0 is the start of antibiotic treatment)	The definition of a recurrent CAUTI is identical to the definition used for inclusion. The pathogen does not have to be identical to the causative pathogen that was identified during the first episode. In case of a suspected recurrence, the following data will be collected: signs and symptoms, GCS, qSOFA, laboratory results, admission, antimicrobial treatment and treatment duration.	90 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mortality	One of the secondary outcomes is 30-day mortality. However, if a patient passes away during the entire course of the study (180 days), this will be recorded.	180 days
Health-related quality of life measured using the PROMIS questionnaires	Health-related quality of life will be measured using the Patient-Reported Outcomes Measurement Information System Scale (PROMIS). This will measure various aspects of physical, mental, and social health. The PROMIS questionnaire will be administered at different times from baseline, to 90 days: baseline, day 3, day 7, day 28 and day 90.	90 days
Health-related quality of life measured using the EQ-5D-5L questionnaire	Health-related quality of life will be measured using the EQ-5D-5L questionnaire which assesses five dimensions of health-related quality of life: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The questionnaire will be administered at different times, from baseline, to 180 days: baseline, day 3, day 7, day 14, day 28, day 90 and day 180.	180 days
Time to resolution of CAUTI symptoms	After inclusion, patients are provided with a diary, in which they record their (CAUTI) symptoms. Additionally, the CAUTI-related symptoms are monitored by telephone at 3 days and then weekly from the start of antibiotic treatment until complete resolution of symptoms. Monthly telephone visits will also be conducted for optimal monitoring of recurrences, until the primary endpoint of 90 days.	90 days
Complications of catheter replacement	Complications of either catheter replacement or retainment and the severity of the complications will be recorded from the moment the procedure has taken place. A few examples of complications are discomfort, bleeding or sepsis. Considering the 3-day timespan between antibiotic initiation and catheter replacement, complications will be administered at 3 days.	3 days
Healthcare costs using a selection of items relevant for this population of the medical consumption (iMCQ) questionnaire	Healthcare costs consist of the costs of the catheter replacement and other healthcare use of the patients. Cost of catheter replacement will be assessed using the micro costing approach in hospital setting. Other healthcare use (e.g. hospital days, cost of medication, outpatient visits, general practitioners visits, homecare visits) will be based on the iMCQ questionnaire administered to patients after 12 weeks and 6 months consisting of a selection of items relevant for this population.	90 days and 180 days
Societal costs using a selection of items relevant for this population of the productivity (iPCQ) questionnaire	Societal costs consisting of productivity losses in paid and unpaid work will be assessed using the iPCQ questionnaire administered to patients after 12 weeks and 6 months consisting of a selection of items of the relevant for this population.	90 days and 180 days
Length of hospital stay and ICU-admission during hospital stay	If the patient presented at the hospital, it will be recorded whether admission occurred, and if so, whether the patient was admitted to a general ward or the intensive care unit. Additionally, if the patient is initially admitted to a general ward and subsequently transferred to the intensive care unit, this transfer will also be documented. The duration of the patient's admission will be recorded.	90 days

Collaborators and Investigators

• Sponsor: Leiden University Medical Center

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2025
• Primary Completion (Estimated): February 1, 2029
• Study Completion (Estimated): February 1, 2029

Study Registration Dates

• First Submitted: March 24, 2025
• First Submitted That Met QC Criteria: April 17, 2025
• First Posted (Actual): April 20, 2025

Study Record Updates

• Last Update Posted (Actual): April 27, 2025
• Last Update Submitted That Met QC Criteria: April 22, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: UTI; Urinary tract infection; Indwelling catheter; CAUTI; Urosepsis; Catheter associated urinary tract infection
• Additional Relevant MeSH Terms: Urogenital Diseases; Pathologic Processes; Male Urogenital Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Disease Attributes; Infections; Communicable Diseases; Urinary Tract Infections
• Other Study ID Numbers: NL88486.058.25

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: After completion of the study, the data sharing plan will be developed.

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