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Evidence based empirical antibiotic treatment for urinary tract infections requiring hospitalisation - TRI-AB trial

Status
Not yet recruiting
Phases
Phase 4
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-520251-24-00
Enrollment
618
Registered
2026-03-27
Start date
Unknown
Completion date
Unknown
Last updated
2026-03-27

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

Conditions

Complicated urinary tract infections (cUTI) requiring hospitalisation

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

DRUGAMPICILLIN
DRUGGENTAMICIN

Sponsors

Odense University Hospital
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime 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

MeasureTime 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.

Outcome results

None listed

Source: EU CTIS · Data processed: Mar 28, 2026