Urinary tract infection and/or bacteremia caused by extended spectrum beta-lactamases-producing Enterobacterales
Conditions
Brief summary
Clinical response 7 to 10 days (test of cure, TOC) after antibiotic treatment has been discontinued. The primary endpoint is met if the patient has no symptoms (i.e. resolution of fever and dysuria > 24 h) and no further antibiotic treatment is necessary, as determined by treating physician.
Detailed description
Growth of EPE in follow up urine culture (microbiological endpoint) at TOC., Faecal culture positive for EPE at follow up at TOC., Death from all causes within 28 days.
Interventions
DRUGAmoxicillin/Clavulanic acid Aurobindo 500 mg/125 mg filmdragerade tabletter
DRUGCiprofloxacin Orion 500 mg filmdragerade tabletter
DRUGEusaprim forte 160 mg/800 mg tabletter
DRUGErtapenem Fresenius Kabi 1 g pulver till koncentrat till infusionsvätska
DRUGlösning
DRUGSelexid 400 mg filmdragerade tabletter
Sponsors
Region Skane
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical response 7 to 10 days (test of cure, TOC) after antibiotic treatment has been discontinued. The primary endpoint is met if the patient has no symptoms (i.e. resolution of fever and dysuria > 24 h) and no further antibiotic treatment is necessary, as determined by treating physician. | — |
Secondary
| Measure | Time frame |
|---|---|
| Growth of EPE in follow up urine culture (microbiological endpoint) at TOC., Faecal culture positive for EPE at follow up at TOC., Death from all causes within 28 days. | — |
Countries
Sweden
Outcome results
None listed