EUCTR2017-003975-80-NL
Active, not recruiting
Phase 1
Shorter treatment of catheter related urinary tract infections - SHORTCUT
Academic Medical Center0 sites300 target enrollmentMarch 7, 2018
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Catheter related urinary tract infection (CAUTI)
- Sponsor
- Academic Medical Center
- Enrollment
- 300
- Status
- Active, not recruiting
- Last Updated
- 5 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •In order to be eligible to participate in this study, a subject must meet all of the following criteria:
- •1\. Indwelling (transurethral or supra\-pubic) urinary catheter with the intention for long\-term continuous catheterization, at least for the next 28 days
- •2\. Signs/symptoms of a systemic UTI, following the modified Loeb criteria \[23,24]:
- •a. patient feels sick
- •b. at least one of the following signs: Fever \> 37\.9 ºC; Rigors; New onset delirium; New/worsened costovertebral angle tenderness or other local signs of UTI; In patients with spinal cord injury: increase of spasticity \[27]
- •3\. Positive dipstick leucocyte esterase test, or sediment \> 10 leucocytes/mm3
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1\.2 Adults (18\-64 years) yes
- •F.1\.2\.1 Number of subjects for this age range 150
Exclusion Criteria
- •1\. Evidence of acute prostatitis or epididymitis
- •2\. Negative urine culture after 3 days, sampled before start of antibiotics. A positive urine culture in patients with an indwelling catheter is defined as any growth of uropathogens \[25].
- •3\. Insufficient understanding of Dutch or English language, or otherwise unable (cognitively impaired or incapacitated) to understand or cooperate in study, or to give informed consent.
- •4\. Patients younger than 18 years of age.
- •5\. Current pregnancy
- •6\. Patients with kidney transplant.
- •7\. Patients with suspected concomitant infection requiring antibiotic treatment
- •8\. Patients with growth of S. aureus or Pseudomonas spp in blood culture
Outcomes
Primary Outcomes
Not specified
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