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

NCT05204563 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 450

Last updated 2025-11-06

Study results available
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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

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

Sponsors & Collaborators

  • Evopoint Biosciences Inc.

    lead INDUSTRY

Principal Investigators

  • Jason Le · Evopoint Biosciences USA, Inc.)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-07-31
Primary Completion
2024-09-29
Completion
2024-09-29
FDA Drug
Yes

Countries

  • United States
  • France
  • Israel
  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05204563 on ClinicalTrials.gov