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New treatment option for Catheter Associated Urinary Tract Infection
Official title REPLACE: The Impact of Catheter Replacement in Patients With Catheter-associated Urinary Tract Infection
ClinicalTrials.gov ID: NCT06936631
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- 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...
- The ability to provide written informed consent for the use of their data.
You likely can't join if
- Having an immunodeficiency: High-dose corticosteroid use (any equivalent of ≥ 20 mg prednisolone per day for \> 4 weeks), severe primary...
- 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.
See the full eligibility criteria
- 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...
- 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.
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Leiden, South Holland, Netherlands
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Leiden, South Holland, Netherlands. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.