REPLACE: The Impact of Catheter Replacement in Patients With Catheter-associated Urinary Tract Infection
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorLeiden University Medical Center
About this trial
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.
Eligibility criteria
Qualifiers
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 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.
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.
Disqualifiers
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)
Expiration of the indication of the indwelling catheter.
Having a planned (routine) catheter replacement during antibiotic therapy.
Contraindications for catheter replacement (judgement treating physician)
Trial design
Treatments tested in this trial
- Catheter replacement
- Catheter retainment
Treatment groups
300 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov