Shorter treatment of urinary tract infections in patients with a urinary catheter
- Conditions
- Catheter related urinary tract infection (CAUTI)Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]
- Registration Number
- EUCTR2017-003975-80-NL
- Lead Sponsor
- Academic Medical Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 300
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
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The primary objective of this study is to establish non-inferiority of treating a symptomatic urinary tract infection in patients with a long-term indwelling catheter for 5 days, compared to the standard duration of 10 days of therapy. ;Secondary Objective: Secondary objectives are to establish differences between the two treatment durations in:<br>- resistance pattern of cultured microorganisms, up to 90 days after randomization<br>- total antibiotic consumption, overall and for UTI, during 90 days after randomization<br>- incidence of acute hospitalizations for urinary tract infection, during 90 days after randomization <br>- incidence of C. difficile associated diarrhea, during 90 days after randomization <br>;Primary end point(s): The primary study endpoint is the recurrence of a symptomatic UTI;Timepoint(s) of evaluation of this end point: 90 days after randomization
- Secondary Outcome Measures
Name Time Method