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Background <p>Catheter-associated urinary tract infection (CAUTI) is the most common healthcare associated infection. Current guidelines state that catheters should be replaced in patients with CAUTI to hasten symptom resolution and to lower the risk of recurrence. However, the available literature is limited and there is significant practice variation globally. The aim of this study is to determine whether not changing the catheter during CAUTI treatment affects the recurrence-risk.</p> Methods and analysis <p>The REPLACE study is a multicentre, non-inferiority- randomized controlled trial designed to assess whether retaining the urinary catheter in patients with CAUTI is non-inferior to replacement in terms of the risk of a recurrent CAUTI within 90 days. Secondary outcome measures include 30-day mortality, health-related quality of life, time to resolution of CAUTI symptoms, complications related to catheter replacement and healthcare and societal costs. Patients aged 18 years or older with an indwelling catheter (transurethral or suprapubic) and CAUTI are eligible. CAUTI is defined according to the Infectious Diseases Society of America (IDSA) criteria. Three hundred patient will be randomised 1:1 to catheter retention (intervention group) or replacement (control group). In the intervention group, the catheter is not replaced. In the control group the catheter will be replaced within 3 days after start of antibiotic therapy. The primary outcome (recurrent CAUTI within 90 days) will be assessed for non-inferiority (margin of 10%).</p> Discussion <p>This trial will address a critical evidence gap and may inform future guidelines regarding catheter management in CAUTI. If replacement is found to have no benefit, this could reduce unnecessary interventions, lower healthcare costs and material use, contribute to sustainability, and lessen the burden on both patients and healthcare organizations.</p> Trial registration <p>Registered at clinicaltrial.gov on 17 April 2025 with registration number: NCT06936631.</p>

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The impact of catheter replacement in patients with catheter-associated urinary tract infection: study protocol paper for a multicentre, non-inferiority randomized controlled trial (REPLACE)

  • 期刊论文

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  • 发表日期：

    2026年2月27日

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  • Eline Schippers,
  • Janneke van Uhm,
  • Merel Wilmsen,
  • Anke Tigchelaar,
  • Wouter Rozemeijer,
  • Barbara Schout,
  • Elske van den Akker-van Marle,
  • Martha van der Beek,
  • Maxime Kummeling,
  • Rolf Groenwold,
  • Suzanne Geerlings,
  • Merel Lambregts

摘要

Background

Catheter-associated urinary tract infection (CAUTI) is the most common healthcare associated infection. Current guidelines state that catheters should be replaced in patients with CAUTI to hasten symptom resolution and to lower the risk of recurrence. However, the available literature is limited and there is significant practice variation globally. The aim of this study is to determine whether not changing the catheter during CAUTI treatment affects the recurrence-risk.

Methods and analysis

The REPLACE study is a multicentre, non-inferiority- randomized controlled trial designed to assess whether retaining the urinary catheter in patients with CAUTI is non-inferior to replacement in terms of the risk of a recurrent CAUTI within 90 days. Secondary outcome measures include 30-day mortality, health-related quality of life, time to resolution of CAUTI symptoms, complications related to catheter replacement and healthcare and societal costs. Patients aged 18 years or older with an indwelling catheter (transurethral or suprapubic) and CAUTI are eligible. CAUTI is defined according to the Infectious Diseases Society of America (IDSA) criteria. Three hundred patient will be randomised 1:1 to catheter retention (intervention group) or replacement (control group). In the intervention group, the catheter is not replaced. In the control group the catheter will be replaced within 3 days after start of antibiotic therapy. The primary outcome (recurrent CAUTI within 90 days) will be assessed for non-inferiority (margin of 10%).

Discussion

This trial will address a critical evidence gap and may inform future guidelines regarding catheter management in CAUTI. If replacement is found to have no benefit, this could reduce unnecessary interventions, lower healthcare costs and material use, contribute to sustainability, and lessen the burden on both patients and healthcare organizations.

Trial registration

Registered at clinicaltrial.gov on 17 April 2025 with registration number: NCT06936631.