NCT05204368

Evaluation of the Efficacy and Safety of Intravenous Imipenem/Cilastatin/XNW4107 in Comparison With Meropenem in Hospitalized Adults With cUTI Including AP (EudraCT no. 2022-000061-40)

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)

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 780 (estimated)
• Sponsor: Evopoint Biosciences Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Complicated Urinary Tract Infection Including Acute Pyelonephritis

Interventions

Type	Name	Description
DRUG	Combination of Imipenem/Cilastatin and XNW4107	Imipenem/Cilastatin 500mg/500mg and XNW4107 250mg for injection
DRUG	Meropenem	Meropenem 1g for injection

Timeline

• Start date: 2023-03-30
• Primary completion: 2025-06-01
• Completion: 2025-12-01
• First posted: 2022-01-24
• Last updated: 2023-02-16

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study