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

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Netherlands
Leiden University Medical Center
RECRUITING
Leiden
Contact Information
Primary
Eline C. Schippers
replace@lumc.nl
+31 (0) 6 22776467
Time Frame
Start Date: 2025-04
Estimated Completion Date: 2029-02
Participants
Target number of participants: 300
Treatments
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.
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.
Related Therapeutic Areas
Sponsors
Leads: Leiden University Medical Center

This content was sourced from clinicaltrials.gov