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Shorter treatment of catheter-related urrinary tract infections

Suspended
Conditions
catheter, UTI, urinary tract infection, antibiotic stewardship, catheter-related, urineweginfectie, catheter-gerelateerd
Registration Number
NL-OMON26262
Lead Sponsor
Department of Infectious Diseases, Academic Medical Center, Amsterdam
Brief Summary

one.

Detailed Description

Not available

Recruitment & Eligibility

Status
Suspended
Sex
Not specified
Target Recruitment
300
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

Exclusion Criteria

1. Evidence of acute prostatitis or epididymitis

2. Negative urine culture after 3 days, sampled before start of antibiotics.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
The primary study endpoint is the recurrence of a symptomatic UTI during 90 days after randomization.
Secondary Outcome Measures
NameTimeMethod
- recurrence of a symptomatic UTI during 180 days after randomization.<br /><br>- time to recurrence of symptomatic UTI <br /><br>- clinical and microbiological cure at end-of-treatment<br /><br>- results of urine cultures at day 30 and day 90 after randomization<br /><br>- resistance pattern of cultured microorganisms after end-of-treatment<br /><br>- total antibiotic consumption, overall and for UTI during 90 days after randomization<br /><br>- acute hospitalizations for UTI during 90 days after randomization<br /><br>- C. difficile associated diarrhea during 90 days after randomization<br>
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