Shorter treatment of catheter-related urinary tract infections

Phase 4

Completed

Conditions: bladder infection
urinary tract infection
10004018
10004994

Registration Number: NL-OMON46655

Lead Sponsor: Academisch Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 300

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

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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary study endpoint is the recurrence of a symptomatic UTI during 90<br /><br>days after end-of-treatment. Relapse and reinfction will be distinguished<br /><br>according to current guidelines with a modification for patients with a urinary<br /><br>catheter. Recurrent bacteriuria is defined as eradication of the initial<br /><br>infecting bacterial species followed by a new episode of bacteriuria after<br /><br>end-of-treatment; relapse in case of presence of the initial infecting<br /><br>micro-organism, and reinfection in case of different micro-organism.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary study endpoints are: recurrence of a symptomatic UTI during 180 days<br /><br>after end-of-treatment, time to recurrence of symptomatic UTI, clinical and<br /><br>microbiological cure at end-of-treatment, results of urine cultures at day 30<br /><br>and day 90 after end-of-treatment, resistance pattern of cultured<br /><br>microorganisms after end-of-treatment, total antibiotic consumption (overall<br /><br>and for UTI) during 90 days after end-of-treatment, acute hospitalizations for<br /><br>urinary tract infection and C. difficile associated diarrhea during 90 days<br /><br>after end-of-treatment. </p><br>