EUCTR2017-003975-80-NLActive, not recruitingPhase 1
Shorter treatment of catheter related urinary tract infections - SHORTCUT
Academic Medical Center0 sites300 target enrollmentStarted: March 7, 2018Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 300
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 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
Investigators
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