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)
Abstract
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)…
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Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design.
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