CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 450 enrolled
Drug / intervention
Combination of Imipenem/Cilastatin and XNW4107 +1 moredrug
Likely dose
Combination of Imipenem/Cilastatin and XNW4107 500mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05204563
NCT05204563Phase 3Completed
CompareCT.gov

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)

Evopoint Biosciences Inc.·interventional·Posted Jan 24, 2022·Updated Nov 6, 2025

In Brief

A Phase 3 clinical trial evaluating Combination of Imipenem/Cilastatin and XNW4107 and Imipenem/Cilastatin/Relebactam for Hospital Acquired Bacterial Pneumonia or Ventilator-Associated Bacterial Pneumonia. Completed, enrolled 450 participants across 35 sites in 4 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHospital Acquired Bacterial Pneumonia or Ventilator-Associated Bacterial Pneumonia
CountriesFrance, Israel, Spain, United States
Collaborators--

Timeline

Phase 3CompletedFinished
20222023202420252026
First PostedJan 24, 2022
Enrollment StartJul 31, 2022
Primary CompletionSep 29, 2024
TodayJul 2, 2026
Enrollment to primary: 2.2 yearsPosted 4.4 years ago

Interventions

Combination of Imipenem/Cilastatin and XNW4107drug

Imipenem/Cilastatin 500mg/500mg and XNW4107 250mg for Injection

Imipenem/Cilastatin/Relebactamdrug

Imipenem/Cilastatin/Relebactam 1.25 g for Injection