Status:
RECRUITING
REPLACE: The Impact of Catheter Replacement in Patients With Catheter-associated Urinary Tract Infection
Lead Sponsor:
Leiden University Medical Center
Conditions:
Catheter Associated Urinary Tract Infection
Eligibility:
All Genders
18+ years
Phase:
NA
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 c...
Detailed Description
As a result of the widespread application of urinary catheterization, catheter-associated urinary tract infection (CAUTI) is the most common healthcare associated infection. To fasten recovery and red...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
April 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2029
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT06936631
Start Date
April 1 2025
End Date
February 1 2029
Last Update
April 27 2025
Active Locations (1)
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1
Leiden University Medical Center
Leiden, South Holland, Netherlands, 2333 ZG