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

Recruiting now · Not applicable

Conditions studied: Catheter Associated Urinary Tract Infection

In brief

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.

Key facts

Study ID: NCT06936631
Run by: Leiden University Medical Center
People needed: 300
Starts: 2025-04-01
Expected to finish: 2029-02-01
Last updated by the study team: 2025-04-27

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

Leiden University Medical Center — Leiden, South Holland, Netherlands (enrolling)

Full record on ClinicalTrials.gov

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