A Multicenter, Randomized, Double-Blind, Double-Dummy, Comparative, Phase 3 Study to Evaluate the Efficacy and Safety of Intravenous Imipenem/Cilastatin/XNW4107 in Comparison With Meropenem in Hospitalized Adults With Complicated Urinary Tract Infections, Including Acute Pyelonephritis.(EudraCT no. 2022-000061-40)

Evopoint Biosciences Inc.1 site in 1 country780 target enrollmentMarch 30, 2023

ConditionsComplicated Urinary Tract Infection Including Acute Pyelonephritis

InterventionsCombination of Imipenem/Cilastatin and XNW4107 Meropenem

DrugsCombination of Imipenem/Cilastatin and XNW4107 Meropenem

Overview

Phase: Phase 3
Intervention: Combination of Imipenem/Cilastatin and XNW4107
Conditions: Complicated Urinary Tract Infection Including Acute Pyelonephritis
Sponsor: Evopoint Biosciences Inc.
Enrollment: 780
Locations: 1
Primary Endpoint: overall success
Status: Not yet recruiting
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This is A Multicenter, Randomized, Double-Blind, Double-Dummy, Comparative, Phase 3 Study to Evaluate the Efficacy and Safety of Intravenous Imipenem/Cilastatin/Funobactam in Comparison with Meropenem in Hospitalized Adults with Complicated Urinary Tract Infections, including Acute Pyelonephritis.

Registry

clinicaltrials.gov

Start Date

March 30, 2023

End Date

December 2025

Last Updated

3 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Evopoint Biosciences Inc.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Patients willing and able to provide written informed consent.
•Willing and able to comply with all study assessments and adhere to the protocol schedule.
•Hospitalized or requiring hospitalization for cUTI or AP in male or female patients ≥18 years on the day of signing informed consent.
•Requiring treatment with IV antibiotic therapy.
•Evidence of AP or cUTI
•At least 1 of the following:
•Nausea or vomiting.
•Chills or rigors or warmth associated with fever (temperature \>38°C).
•Peripheral white blood cell count (WBC) \>10,000/mm³ or bandemia , regardless of WBC count.
•Having at least 1 of the following complicated factors for cUTI (not required for AP):

Exclusion Criteria

•Patients with any of the following conditions:
•Suspected or confirmed perinephric abscess
•Suspected or confirmed renal corticomedullary abscess
•Suspected or confirmed acute or chronic bacterial prostatitis, orchitis, or epididymitis, as determined by history and/or physical examination
•Known polycystic kidney disease or only 1 functional kidney
•Known chronic vesicoureteral reflux
•Previous renal transplantation or planned renal transplantation within 2 weeks of study entry
•Patients receiving renal replacement therapy
•Complete, permanent obstruction of the urinary tract
•Urinary tract symptoms attributable to a sexually transmitted disease.

Arms & Interventions

Imipenem/Cilastatin/XNW4107

Imipenem/Cilastatin 500mg/500mg in combination with XNW4107 250mg ,q6h(0.5h infusion)

Intervention: Combination of Imipenem/Cilastatin and XNW4107

Meropenem

Meropenem 1g ,q8h (0.5h infusion)

Intervention: Meropenem

Outcomes

Primary Outcomes

overall success

Time Frame: Day 21[±2 days]

The proportion of patients who achieve overall success at the Test of cure(TOC) visit in the micro-modified-intent-to-treat(micro-MITT) population. Overall success requires symptomatic clinical success and microbiologic success at the TOC visit.

Secondary Outcomes

overall success(Day 28[±3 days])
symptomatic clinical success(Day 4; EOT: from treatment day 7 up to day 15; TOC: Day 21[±2 days]; LFU: Day 28[±3 days])
microbiological success(EOT: from treatment day 7 up to day 15; TOC: Day 21[±2 days]; LFU: Day 28[±3 days])
By-pathogen microbiological success(EOT: from treatment day 7 up to day 15; TOC: Day 21[±2 days]; LFU: Day 28[±3 days])
The proportion of overall success; symptomatic clinical, and microbiologic success(EOT: from treatment day 7 up to day 15; TOC: Day 21[±2 days]; LFU: Day 28[±3 days])
clinical success(Day 21[±2 days])