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Clinical Trials/EUCTR2017-003975-80-NL
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.

Registry
who.int
Start Date
March 7, 2018
End Date
TBD
Last Updated
5 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
Academic Medical Center

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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