Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT06936631

REPLACE: The Impact of Catheter Replacement in Patients With Catheter-associated Urinary Tract Infection

Led by Leiden University Medical Center · Updated on 2025-04-27

300

Participants Needed

1

Research Sites

200 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

REPLACE: The Impact of Catheter Replacement in Patients With Catheter-associated Urinary Tract Infection

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Aged 18 years or older.
  • An indwelling catheter (transurethral or suprapubic) that has been in place for at least 2 weeks.
  • At least one symptom of catheter-associated urinary tract infection as defined by guidelines (fever, chills, altered mental status, malaise, flank pain, hematuria, pelvic discomfort, or related symptoms).
  • Urine culture showing infection with 1 or more bacterial species at 1000 CFU/mL or higher, or urine culture with lower counts plus positive blood culture with the same organism.
  • Ability to provide written informed consent.
  • Proficiency in Dutch or English to communicate and complete questionnaires.
Not Eligible

You will not qualify if you...

  • Having an immunodeficiency, including high-dose corticosteroid use (≥ 20 mg prednisolone daily for > 4 weeks), severe primary immunodeficiency, organ transplant, or neutropenia.
  • Catheter no longer indicated.
  • Planned routine catheter replacement during antibiotic treatment.
  • Contraindications for catheter replacement as judged by the treating physician.
  • Having kidney catheters such as nephrostomy or double-J catheter.
  • Need for bladder irrigations due to gross hematuria.
  • Presence of bladder stones.
  • Female patients who are pregnant.
  • Life expectancy less than 3 months.

AI-Screening

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Trial Site Locations

Total: 1 location

1

Leiden University Medical Center

Leiden, South Holland, Netherlands, 2333 ZG

Actively Recruiting

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Research Team

E

Eline C. Schippers

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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