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

NCT05204563 | Completed Phase 3 Results DMC FDA Drug

• 1 other identifier: XNW4107-302
• Study Type: interventional
• Target: 450
• Locations: 4 countries
• Sites: 35

Brief 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

Outcome Measures

Primary Outcomes (1)

• Day 14 All-cause Mortality Rate

  The all-cause mortality rate at Day 14 was calculated as the percentage of participants in each treatment group who experienced mortality, regardless of the cause, from randomization up to Day 14.

  Day 14

Secondary Outcomes (26)

• Day 28 All-cause Mortality Rate

  Day 28

• Day 14 and Day 28 All-cause Mortality Rate in the Micro-MITT Population

  Day 14, Day 28

• Day 14 and Day 28 All-cause Mortality Rate in the Extended Micro-MITT

  Day 14, Day 28

• Day 14 and Day 28 All-cause Mortality Rate in the Clinically Evaluable (CE) Population

  Day 14, Day 28

• Day 14 and Day 28 All-cause Mortality Rate in the Microbiologically Evaluable (ME) Population

  Day 14, Day 28

Study Arms (2)

Imipenem/Cilastatin/XNW4107

EXPERIMENTAL

Imipenem/Cilastatin 500mg/500mg in combination with XNW4107 250mg, Q6h (0.5h Infusion)

Drug: Combination of Imipenem/Cilastatin and XNW4107

Imipenem/Cilastatin/Relebactam

ACTIVE COMPARATOR

Imipenem/Cilastatin/Relebactam 1.25g Q6h (0.5h Infusion)

Drug: Imipenem/Cilastatin/Relebactam

Interventions

Combination of Imipenem/Cilastatin and XNW4107 DRUG

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

Imipenem/Cilastatin/XNW4107

Imipenem/Cilastatin/Relebactam DRUG

Imipenem/Cilastatin/Relebactam 1.25 g for Injection

Also known as: Recarbrio

Imipenem/Cilastatin/Relebactam

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Has HABP or VABP as defined below and requires treatment with IV antibiotic therapy. Fulfills clinical criteria, with onset of criteria occurring after more than 48 hours of hospitalization or within 7 days after discharge from a hospital (for HABP); or at least 48 hours after mechanical ventilation (for VABP)
• Fulfills clinical criteria with symptoms or signs of cough, expectorated sputum production, dyspnea, worsening oxygenation, increase in respiratory secretions, fever/ hypothermia..
• Fulfills laboratory test criteria with Leukocytosis/ Leukocytosis/ increase in immature neutrophils
• Fulfill radiograph criteria with presence of new or progressive infiltrate(s) suggestive of bacterial pneumonia in X-ray/ Chest CT.

You may not qualify if:

• Gram stain from a respiratory sample shows only Gram-positive cocci.
• Have known or suspected community-acquired bacterial pneumonia, atypical pneumonia, viral pneumonia including Coronavirus disease, or chemical pneumonia.
• Have HABP/VABP caused by an obstructive process, including lung cancer or other known obstruction.
• Have received effective antibacterial drug therapy for the index infection of HABP/VABP for more than 24 hours during the previous 72 hours .
• Have central nervous system infection.
• Documented presence of immunodeficiency or an immunocompromised condition
• Documented or severe hypersensitivity or previous severe adverse drug reaction, especially to any beta-lactam antibiotics, or any of the excipients used in the study drug formulations.
• History of a seizure disorder requiring ongoing treatment with anti-convulsive therapy or prior treatment with anti-convulsive therapy within the last 3 years.
• eGFR \<15 mL/min/1.73㎡.
• Patient is receiving hemodialysis or peritoneal dialysis.
• Anticipated to be treated with any of Valproic acid or divalproex sodium, concomitant systemic Gram-negative antibacterial agents, or concomitant systemic antifungal or antiviral therapy for the index infection of HABP/VABP.
• Life expectancy is \<3 days.
• Patients in refractory septic shock
• Patients with 1 or more of laboratory abnormalities in baseline specimens.
• History of active liver disease or cirrhosis.

Sponsors & Collaborators

• Evopoint Biosciences Inc.: lead

Study Sites (35)

Denver Health and Hospital Authority

Denver, Colorado, 80204, United States

Location

Hartford Hospital

Hartford, Connecticut, 37920, United States

Location

Jackson Memorial Hospital (JMH) - Ryder Trauma Center

Miami, Florida, 33136, United States

Location

USF-TGH

Tampa, Florida, 33606, United States

Location

University of Maryland Medical Center

Baltimore, Maryland, 21201, United States

Location

Cox Health

Springfield, Missouri, 65807, United States

Location

VA medical center

Buffalo, New York, 14215, United States

Location

Carolinas Medical Center

Charlotte, North Carolina, 28204, United States

Location

University Hospitals Cleveland Medical Center

Cleveland, Ohio, 44106, United States

Location

The University of Tennessee Medical Center

Knoxville, Tennessee, 37920, United States

Location

CHU de Nice

Nice, Alpes Maritimes, 06200, France

Location

Hôpitaux Universitaires de Strasbourg

Strasbourg, Alsace, 67000, France

Location

Nouvel Hopital CIVIL/ Medecine Intensive Reanimation

Strasbourg, Bas-Rhin, 67091, France

Location

Chu Nimes

Nîmes, GARD, 30029, France

Location

Chu Reims- Medical Icu

Reims, Grand Est, 51100, France

Location

Cochin

Paris, Paris, 75014, France

Location

Groupe Hospitalier Paris Saint-Joseph

Paris, Paris, 75014, France

Location

APHP

Paris, Paris, 75018, France

Location

intensive Unit Care CHU Amiens Picardie

Amiens, Picardie, 80054, France

Location

CH victor dupouy

Argenteuil, 95100, France

Location

Hôpital Foch

Suresnes, Île-de-France Region, 92150, France

Location

Sheba Medical Center

Ramat Gan, Center, 5262100, Israel

Location

Wolfson Medical Center

H̱olon, Central District, 58100, Israel

Location

Bnei-Zion Medical Center

Haifa, Haifa District, 3339419, Israel

Location

Shamir Medical Center

Be’er Ya‘aqov, HaMercaz, 70300, Israel

Location

Hillel Yaffe Medical Center

Hadera, Israel, 38100, Israel

Location

Rambam Critical Care division

Haifa, Israel, 3525408, Israel

Location

Tel Aviv Medical Center

Tel Aviv, Israel, 64239, Israel

Location

Galilee Medical Center / Department int med A

Nahariya, Western Galilee, 2210001, Israel

Location

Hospital del Mar

Barcelona, Barcelona, 08003, Spain

Location

Hospital Universitari Vall Hebron

Barcelona, Barcelona, 08035, Spain

Location

Hospital Clínic of Barcelona

Barcelona, Barcelona, 08036, Spain

Location

Hospital de la Santa Creu i Sant Pau

Barcelona, Barcelona, 08041, Spain

Location

Bellvitge University Hospital

L'Hospitalet de Llobregat, Barcelona, 08907, Spain

Location

Hospital Universitario de Tarragona Joan XXIII

Tarragona, Tarragona, 43007, Spain

Location

MeSH Terms

Interventions

Cilastatin; imipenem, cilastatin and relebactam

Intervention Hierarchy (Ancestors)

Cyclopropanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Fatty Acids, Monounsaturated; Fatty Acids, Unsaturated; Fatty Acids; Lipids

Results Point of Contact

• Title: Evopoint Biosciences
• Organization: Evopoint Biosciences USA, Inc.

info@evopointbio.com

646-750-2661

Study Officials

• Jason Le

  Evopoint Biosciences USA, Inc.)

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 5, 2022
• First Posted: January 24, 2022
• Study Start: July 31, 2022
• Primary Completion: September 29, 2024
• Study Completion: September 29, 2024
• Last Updated: November 6, 2025
• Results First Posted: November 6, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

IL (8); ES (6); FR (11); US (10)