A Phase 3, randomized, double-blind, double-dummy, multicenter, multinational study to assess the efficacy and safety of orally administered tebipenem pivoxil hydrobromide (TBP-PI-HBr) compared to intravenously (IV) administered imipenem-cilastatin in patients with complicated urinary tract infection (cUTI) or acute pyelonephritis (AP)

Conditions

complicated urinary tract infection (cUTI) or acute pyelonephritis (AP)

Brief summary

Overall response (combined per-patient clinical cure and favorable microbiological response) at the TOC visit in the micro-ITT Population

Detailed description

Overall response at the TOC visit in the ME Population, Overall response at the EOT and LFU visits in the micro-ITT and ME Populations, Clinical response at the EOT, TOC and LFU visits in the micro-ITT, Clinically Evaluable (CE) and ME Populations, Microbiological response at the EOT, TOC and LFU visits in the micro-ITT and ME Populations, Overall, Clinical and Microbiological response at the TOC, EOT and LFU visits in the micro-ITT and ME Populations in patients with drug resistant Enterobacterales, Treatment-emergent AEs (TEAEs) and SAEs and change from Baseline results for clinical laboratory tests, ECGs, and vital sign measurements in the Safety Population, TBP plasma concentration in the TBP PK Population, Exploratory: Clinical response and Microbiological response at Day 5 in the micro-ITT Population, Exploratory: Time (days) to defervescence in patients with a documented fever at Screening or Day 1 in the micro-ITT Population, Exploratory: Occurrence of superinfection and new infection in the micro-ITT Population, Exploratory: TBP or imipenem concentration in urine in the Urine PK Population subgroup, Exploratory: Composite ordinal endpoint (DOOR) at TOC and LFU in the micro-ITT Population

Related papers

No related papers found yet.

Interventions

DRUGTebipenem pivoxil

DRUGSODIUM CHLORIDE

DRUGIMIPENEM AND CILASTATIN

DRUGPlacebo to match Tebipenem pivoxil

DRUGtablet

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Overall response (combined per-patient clinical cure and favorable microbiological response) at the TOC visit in the micro-ITT Population	—

Secondary

Measure	Time frame
Overall response at the TOC visit in the ME Population, Overall response at the EOT and LFU visits in the micro-ITT and ME Populations, Clinical response at the EOT, TOC and LFU visits in the micro-ITT, Clinically Evaluable (CE) and ME Populations, Microbiological response at the EOT, TOC and LFU visits in the micro-ITT and ME Populations, Overall, Clinical and Microbiological response at the TOC, EOT and LFU visits in the micro-ITT and ME Populations in patients with drug resistant Enterobacterales, Treatment-emergent AEs (TEAEs) and SAEs and change from Baseline results for clinical laboratory tests, ECGs, and vital sign measurements in the Safety Population, TBP plasma concentration in the TBP PK Population, Exploratory: Clinical response and Microbiological response at Day 5 in the micro-ITT Population, Exploratory: Time (days) to defervescence in patients with a documented fever at Screening or Day 1 in the micro-ITT Population, Exploratory: Occurrence of superinfection and new in	—

Measure

Time frame

Overall response at the TOC visit in the ME Population, Overall response at the EOT and LFU visits in the micro-ITT and ME Populations, Clinical response at the EOT, TOC and LFU visits in the micro-ITT, Clinically Evaluable (CE) and ME Populations, Microbiological response at the EOT, TOC and LFU visits in the micro-ITT and ME Populations, Overall, Clinical and Microbiological response at the TOC, EOT and LFU visits in the micro-ITT and ME Populations in patients with drug resistant Enterobacterales, Treatment-emergent AEs (TEAEs) and SAEs and change from Baseline results for clinical laboratory tests, ECGs, and vital sign measurements in the Safety Population, TBP plasma concentration in the TBP PK Population, Exploratory: Clinical response and Microbiological response at Day 5 in the micro-ITT Population, Exploratory: Time (days) to defervescence in patients with a documented fever at Screening or Day 1 in the micro-ITT Population, Exploratory: Occurrence of superinfection and new in

—

Countries

Bulgaria, Croatia, Estonia, Greece, Hungary, Latvia, Poland, Romania, Slovakia

Outcome results

None listed