bladder infection urinary tract infection
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: At presentation with current episode of catheter related urinary tract infection: 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. 3. Positive dipstick leucocyte esterase test, or sediment > 10 leucocytes/mm3. If a dipstick or sediment was not performed, a positive urine is needed.
Exclusion criteria
Exclusion criteria: 1. Evidence of acute prostatitis or epididymitis 2. 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. 3. Patients younger than 18 years of age. 4. Current pregnancy 5. Patients with kidney transplant. 6. Patients with suspected concomitant infection requiring antibiotic treatment 7. Patients with growth of S. aureus or pseudomonas spp in blood culture. 8. Patients that cannot be treated with (combinations of) the following antibiotics: amoxicillin, amoxicillin/clavulanic acid, cefuroxime, cefotaxime, ceftriaxone, ceftazidime, meropenem, gentamicin, tobramycin, ciprofloxacin, cotrimoxazole, vancomycin.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary study endpoint is the recurrence of a symptomatic UTI during 90 days after end-of-treatment. Relapse and reinfction will be distinguished according to current guidelines with a modification for patients with a urinary catheter. Recurrent bacteriuria is defined as eradication of the initial infecting bacterial species followed by a new episode of bacteriuria after end-of-treatment; relapse in case of presence of the initial infecting micro-organism, and reinfection in case of different micro-organism. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary study endpoints are: recurrence of a symptomatic UTI during 180 days after end-of-treatment, time to recurrence of symptomatic UTI, clinical and microbiological cure at end-of-treatment, results of urine cultures at day 30 and day 90 after end-of-treatment, resistance pattern of cultured microorganisms after end-of-treatment, total antibiotic consumption (overall and for UTI) during 90 days after end-of-treatment, acute hospitalizations for urinary tract infection and C. difficile associated diarrhea during 90 days after end-of-treatment. | — |
Countries
Netherlands