NCT06936631 REPLACE: The Impact of Catheter Replacement in Patients With Catheter-associated Urinary Tract Infection
| NCT ID | NCT06936631 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Leiden University Medical Center |
| Condition | Catheter Associated Urinary Tract Infection |
| Study Type | INTERVENTIONAL |
| Enrollment | 300 participants |
| Start Date | 2025-04 |
| Primary Completion | 2029-02 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 300 participants in total. It began in 2025-04 with a primary completion date of 2029-02.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06936631 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Catheter Associated Urinary Tract Infection. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06936631 currently recruiting?
Yes, NCT06936631 is actively recruiting participants. Contact the research team at replace@lumc.nl for enrollment information.
Where is the NCT06936631 trial being conducted?
This trial is being conducted at Leiden, Netherlands.
Who is sponsoring the NCT06936631 clinical trial?
NCT06936631 is sponsored by Leiden University Medical Center. The trial plans to enroll 300 participants.