NCT05204563

Imipenem/Cilastatin-XNW4107 Versus Imipenem/Cilastatin/Relebactam for Treatment of Participants With Bacterial Pneumonia (XNW4107-302, REITAB-2)

A Multicenter, Randomized, Double-Blind, Comparative, Phase 3 Study to Evaluate the Efficacy and Safety of Intravenous Imipenem/Cilastatin/XNW4107 in Comparison With Imipenem/Cilastatin/Relebactam in Adults With Hospital-Acquired Bacterial Pneumonia or Ventilator-Associated Bacterial Pneumonia (EudraCT no. 2022-000081-18) (EUCTR no. 2022-501952-27-00) (IND no. 146614)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 450 (actual)
• Sponsor: Evopoint Biosciences Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study aims to compare treatment with Imipenem/Cilastatin-XNW4107 (IMI-XNW4107) with imipenem/cilastatin/relebactam (IMI/REL) in participants with hospital-acquired or ventilator-associated bacterial pneumonia (HABP or VAPB, respectively). The primary hypothesis is that IMI-XNW4107 is non-inferior to IMI/REL in all-cause mortality.

Conditions

• Hospital Acquired Bacterial Pneumonia or Ventilator-Associated Bacterial Pneumonia

Interventions

Type	Name	Description
DRUG	Combination of Imipenem/Cilastatin and XNW4107	Imipenem/Cilastatin 500mg/500mg and XNW4107 250mg for Injection
DRUG	Imipenem/Cilastatin/Relebactam	Imipenem/Cilastatin/Relebactam 1.25 g for Injection

Timeline

• Start date: 2022-07-31
• Primary completion: 2024-09-29
• Completion: 2024-09-29
• First posted: 2022-01-24
• Last updated: 2025-11-06
• Results posted: 2025-11-06

Locations

35 sites across 4 countries: United States, France, Israel, Spain

Regulatory

• FDA-regulated drug study