Complicated urinary tract infections (cUTI) requiring hospitalisation
Conditions
Brief summary
Clinical cure on day 3 (resolution of cUTI-related symptoms and fever, together with clinical improvement and no need for escalating systemic antimicrobial therapy)
Detailed description
30/90/365-day mortality, Microbiological cure on Day 3, Time to oral-only antibiotic therapy, Length of hospital stay, Antibiotic treatment duration (combined iv and oral), Nephrotoxicity within 30 days, Proportion of treatment-related serious adverse reactions (SAE) and suspected unexpected serious adverse reactions (SUSAR), Secondary infections (C. difficile or genital/oral Candida within 30 days of enrollment), Hospital readmission within 90 days due to UTI, Post-discharge antibiotic prescription redemption within 90 days for UTI associated antibiotics.
Interventions
Sponsors
Eligibility
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical cure on day 3 (resolution of cUTI-related symptoms and fever, together with clinical improvement and no need for escalating systemic antimicrobial therapy) | — |
Secondary
| Measure | Time frame |
|---|---|
| 30/90/365-day mortality, Microbiological cure on Day 3, Time to oral-only antibiotic therapy, Length of hospital stay, Antibiotic treatment duration (combined iv and oral), Nephrotoxicity within 30 days, Proportion of treatment-related serious adverse reactions (SAE) and suspected unexpected serious adverse reactions (SUSAR), Secondary infections (C. difficile or genital/oral Candida within 30 days of enrollment), Hospital readmission within 90 days due to UTI, Post-discharge antibiotic prescription redemption within 90 days for UTI associated antibiotics. | — |