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

NCT ID: NCT06936631

Last Updated: 2025-04-27

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 300 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-04-30
• Study Completion Date: 2029-02-28

Brief Summary

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.

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.

Conditions

Catheter Associated Urinary Tract Infection

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: OTHER

Catheter replacement

Intervention Type: PROCEDURE

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.

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.

Group Type: EXPERIMENTAL

Catheter retainment

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Leiden University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

ecschippers

Coordinating investigator/ project leader

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Leiden University Medical Center

Leiden, South Holland, Netherlands

Site Status: RECRUITING

Countries

Netherlands

Central Contacts

Eline C. Schippers

Role: CONTACT

replace@lumc.nl

+31 (0) 6 22776467

Other Identifiers

NL88486.058.25

Identifier Type: -

Identifier Source: org_study_id