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Shorter treatment of catheter-related urinary tract infections

Shorter treatment of catheter-related urinary tract infections - SHORTCUT

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON46655
Enrollment
300
Registered
2018-02-01
Start date
2018-07-18
Completion date
Unknown
Last updated
2024-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

bladder infection urinary tract infection

Interventions

The intervention group will receive 5 days of antibiotic therapy, as compared to 10 days in the control group.

Sponsors

Academisch Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

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

MeasureTime 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

MeasureTime 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

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)