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Shorter treatment of catheter-related urrinary tract infections

Shorter treatment of catheter related UTI's

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON26262
Enrollment
300
Registered
2017-07-11
Start date
2017-09-01
Completion date
Unknown
Last updated
2024-02-28

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

Conditions

catheter, UTI, urinary tract infection, antibiotic stewardship, catheter-related, urineweginfectie, catheter-gerelateerd

Interventions

Patients will be treated with antibiotics according to SWAB/Verenso guideline. In the intervention arm, patients will receive 5 days of therapy. In control arm will receive 10 days of antibiotic treat

Sponsors

Department of Infectious Diseases, Academic Medical Center, Amsterdam
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Indwelling (transurethral or supra-pubic) urinary catheter with the intention for long term continuous catheterization, and 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 3. Positive dipstick leucocyte esterase test, or sediment > 10 leucocytes/mm3

Exclusion criteria

Exclusion criteria: 1. Evidence of acute prostatitis or epididymitis 2. Negative urine culture after 3 days, sampled before start of antibiotics. 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 planned removal of catheter or switch to intermittent catheterization within 28 days (4 weeks) after inclusion.

Design outcomes

Primary

MeasureTime frame
The primary study endpoint is the recurrence of a symptomatic UTI during 90 days after randomization.

Secondary

MeasureTime frame
- recurrence of a symptomatic UTI during 180 days after randomization. - 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 randomization - resistance pattern of cultured microorganisms after end-of-treatment - total antibiotic consumption, overall and for UTI during 90 days after randomization - acute hospitalizations for UTI during 90 days after randomization - C. difficile associated diarrhea during 90 days after randomization

Contacts

Public ContactJ.E. Oryszczyn

Academic Medical Center Amsterdam, F4-106

j.e.oryszczyn@amsterdamumc.nl020-5666807

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)