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

NCT06936631 | Recruiting

• 1 other identifier: NL88486.058.25
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Catheter Associated Urinary Tract Infection

Keywords

Catheter associated urinary tract infection; CAUTI; Urinary tract infection; UTI; Indwelling catheter; Urosepsis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Mortality

  180 days

• Health-related quality of life measured using the PROMIS questionnaires

  90 days

• Health-related quality of life measured using the EQ-5D-5L questionnaire

  180 days

• Time to resolution of CAUTI symptoms

  90 days

• Complications of catheter replacement

  3 days

Study Arms (2)

Catheter replacement

OTHER

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

Catheter retainment

EXPERIMENTAL

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

Interventions

Catheter replacement 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 replacement

Catheter retainment 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

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 18 years or older.
• An indwelling catheter, either a transurethral or suprapubic catheter, that has been in place for at least 2 weeks.
• 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.
• 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.
• The ability to provide written informed consent for the use of their data.
• Sufficient proficiency in the Dutch or English language, both spoken and written, to effectively communicate with the research team and accurately complete the questionnaires.

You may not qualify if:

• 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)
• Expiration of the indication of the indwelling catheter.
• Having a planned (routine) catheter replacement during antibiotic therapy.
• Contraindications for catheter replacement (judgement treating physician)
• Kidney catheters (nephrostomy or double-J catheter).
• Needing bladder irrigations because of gross haematuria.
• Having bladder stones.
• Female patients who are pregnant.
• Having a life expectancy of \< 3 months.

Sponsors & Collaborators

• Leiden University Medical Center: lead

Study Sites (1)

Leiden University Medical Center

Leiden, South Holland, 2333 ZG, Netherlands

RECRUITING

MeSH Terms

Conditions

Urinary Tract Infections

Condition Hierarchy (Ancestors)

Infections; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Central Study Contacts

Eline C. Schippers

CONTACT

+31 (0) 6 22776467; replace@lumc.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Coordinating investigator/ project leader

Study Record Dates

• First Submitted: March 24, 2025
• First Posted: April 20, 2025
• Study Start: April 1, 2025
• Primary Completion (Estimated): February 1, 2029
• Study Completion (Estimated): February 1, 2029
• Last Updated: April 27, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share

Locations

NL (1)