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Clinical Trials/EUCTR2017-003975-80-NL
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

Sponsor
Academic Medical Center

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