Clinical trial NCT06936631: REPLACE: The Impact of Catheter Replacement in Patients With Catheter-associated Urinary Tract Infection
Official title: REPLACE: the Impact of Catheter Replacement in Patients With Catheter-associated Urinary Tract Infection
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Catheter Associated Urinary Tract Infection
Keywords: Catheter associated urinary tract infection
CAUTI
Urinary tract infection
UTI
Indwelling catheter
Urosepsis
Lead sponsor: Leiden University Medical Center
Sponsor class: OTHER
First posted: 2025-04-20
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.

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 reduce the risk of a recurrent CAUTI, current guidelines recommend to replace the catheter at the onset of a CAUTI when the indwelling catheter has been in place for more than 2 weeks. This recommendation, however, is based on limited evidence. Additionally, there is significant practice variation in the Netherlands regarding catheter replacement in CAUTI. Given the limited evidence and significant practice variation in the Netherlands, this Randomized Controlled Trial including 300 CAUTI patients is needed.

The main question this study aims to answer is whether not changing the urinary catheter (catheter retainment) during a catheter-associated urinary tract infection (CAUTI) is non-inferior to catheter replacement in terms of the risk of a recurrent CAUTI within 90 days. Secondary objectives include 30-day mortality, health-related quality of life, time to resolution of CAUTI symptoms, complications of catheter replacement (e.g., discomfort, bleeding, sepsis) and healthcare and societal costs.

In the intervention group there will be no catheter replacement during CAUTI, meaning there will be no catheter replacement during the entire course of antibiotic treatment. In this group, catheter replacement will follow the patients regular replacement schedule, consequently meaning that it occurs outside the duration of the antibiotic treatment . The duration of antibiotic treatment is 10 days for both men and women. The control group follows the current guidelines. In this group, the catheter will be replaced within 3 days after the start of antibiotic therapy.

Eligibility 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.

Primary outcomes:
measure: Recurrent CAUTI within 90 days post-antibiotic treatment (T0 is the start of antibiotic treatment)
timeFrame: 90 days
Secondary outcomes:
measure: Mortality
timeFrame: 180 days
measure: Health-related quality of life measured using the PROMIS questionnaires
timeFrame: 90 days
measure: Health-related quality of life measured using the EQ-5D-5L questionnaire
timeFrame: 180 days
measure: Time to resolution of CAUTI symptoms
timeFrame: 90 days
measure: Complications of catheter replacement
timeFrame: 3 days
measure: Healthcare costs using a selection of items relevant for this population of the medical consumption (iMCQ) questionnaire
timeFrame: 90 days and 180 days
measure: Societal costs using a selection of items relevant for this population of the productivity (iPCQ) questionnaire
timeFrame: 90 days and 180 days
measure: Length of hospital stay and ICU-admission during hospital stay
timeFrame: 90 days
Other outcomes:
Locations:
city: Leiden
country: Netherlands
facility: Leiden University Medical Center
state: Zuid-Holland
Study officials:
References: