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.

NCT Number	NCT06936631
Lead Sponsor	Leiden University Medical Center
Conditions	Catheter Associated Urinary Tract Infection
Enrollment	300 participants
Start Date	2025-04
Primary Completion	2029-02 (estimated)
Study Completion	2029-02 (estimated)
Updated on ClinicalTrials.gov	2025-04-27