catheter associated urinary tract infection (CAUTI) bladder infection in patients with a urinary catheter
Conditions
Interventions
In the intervention group, the catheter is not replaced during CAUTI treatment.
Choice of antibiotic agent follows standard care guidelines, with
adjustments based on culture results. In this group,
Sponsors
Leids Universitair Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: In order to participate in the trial, a patient must meet all of the following criteria: 1. Aged 18 years or older. 2. The patient has had an indwelling catheter, either a transurethral or suprapubic, for at least 2 weeks. 3. At least one CAUTI-related symptom, defined according to the IDSA guideline: 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. 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
Exclusion criteria: A potential subject who meets any of the following criteria will be excluded from participation in the trial: 1. Having an immunodeficiency: High-dose corticosteroid use (equivalent of >= 20 mg prednisolone per day for > 4 weeks), severe primary immunodeficiency, organ transplant, neutropenia (absolute neutrophil count
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary outcome: Recurrent CAUTI within 90 days post-antibiotic treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcomes include 30-day mortality, health-related quality of life (PROMIS, EQ-5D-5L), time to resolution of CAUTI symptoms, complications of catheter replacement (e.g., discomfort, bleeding, sepsis), length of hospital stay, healthcare costs, and productivity. | — |
Countries
Netherlands
Contacts
Public ContactE.C. Schippers
Leids Universitair Medisch Centrum
Outcome results
None listed