Impact of catheter replacement on urinary tract infections

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• NowCath Foley: a new catheter to lower bladder infections and blockages for long-term users

  A new silicone indwelling catheter with extra drainage eyelets and a flexible skirt is being tested to see if it reduces catheter-associated urinary tract infections and blockages in adults who need long-term Foley catheters.

  Recruiting at 3 sites Nowwell AS · Herning and 2 other locations · NCT07782762

• Adhesive versus elastic leg devices to secure urinary catheters in critically ill adults

  This trial will test whether adhesive or elastic leg securement devices better prevent meatal injuries, reduce discomfort, and lower catheter-associated urinary tract infections in critically ill adults with urinary catheters.

  Recruiting Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau · Barcelona · NCT07093437

• Comparing T-Control and Foley Catheters for Long-Term Bladder Catheter Patients

  This pilot randomized study tests whether the T-Control catheter provides more comfort and a better experience than a standard Foley catheter for people needing a long-term bladder tube.

  Recruiting at 2 sites Rethink Medical SL · Santa Cruz de Tenerife, Tenerife and 1 other locations · NCT05860231

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.