Impact of catheter replacement on urinary tract infections
REPLACE: the Impact of Catheter Replacement in Patients With Catheter-associated Urinary Tract Infection
This study is testing if changing bladder catheters during treatment for urinary tract infections helps people avoid getting infections again compared to keeping their current catheters.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 300 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Leiden University Medical Center Academic / other |
| Locations | 1 site (Leiden, South Holland) |
| Trial ID | NCT06936631 on ClinicalTrials.gov |
What this trial studies
This study investigates whether changing bladder catheters during antibiotic treatment for catheter-associated urinary tract infections (CAUTI) is beneficial. Patients with CAUTI will be randomized into two groups: one will have their catheters replaced, while the other will retain their existing catheters throughout the treatment. The study aims to determine if catheter retainment is non-inferior to replacement in preventing recurrent CAUTI within 90 days. Secondary objectives include assessing mortality, quality of life, symptom resolution time, complications from catheter replacement, and associated healthcare costs.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with an indwelling catheter in place for at least two weeks and experiencing symptoms of CAUTI.
Not a fit: Patients who do not have an indwelling catheter or those with less than two weeks of catheterization may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could reduce unnecessary catheter replacements, leading to fewer invasive procedures and lower healthcare costs for patients.
How similar studies have performed: This approach is novel and has not been extensively tested in previous studies, highlighting the need for this research.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Leiden, South Holland
- Leiden University Medical Center — Leiden, South Holland, Netherlands (Recruiting)
Study contacts
- Study coordinator: Eline C. Schippers
- Email: replace@lumc.nl
- Phone: +31 (0) 6 22776467
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.