Imipenem/Cilastatin-XNW4107 Versus Imipenem/Cilastatin/Relebactam for Treatment of Participants With Bacterial Pneumonia (XNW4107-302, REITAB-2)
NCT ID: NCT05204563
Last Updated: 2025-11-06
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
450 participants
INTERVENTIONAL
2022-07-31
2024-09-29
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Imipenem/Cilastatin/XNW4107
Imipenem/Cilastatin 500mg/500mg in combination with XNW4107 250mg, Q6h (0.5h Infusion)
Combination of Imipenem/Cilastatin and XNW4107
Imipenem/Cilastatin 500mg/500mg and XNW4107 250mg for Injection
Imipenem/Cilastatin/Relebactam
Imipenem/Cilastatin/Relebactam 1.25g Q6h (0.5h Infusion)
Imipenem/Cilastatin/Relebactam
Imipenem/Cilastatin/Relebactam 1.25 g for Injection
Interventions
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Combination of Imipenem/Cilastatin and XNW4107
Imipenem/Cilastatin 500mg/500mg and XNW4107 250mg for Injection
Imipenem/Cilastatin/Relebactam
Imipenem/Cilastatin/Relebactam 1.25 g for Injection
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Fulfills clinical criteria with symptoms or signs of cough, expectorated sputum production, dyspnea, worsening oxygenation, increase in respiratory secretions, fever/ hypothermia..
3. Fulfills laboratory test criteria with Leukocytosis/ Leukocytosis/ increase in immature neutrophils
4. Fulfill radiograph criteria with presence of new or progressive infiltrate(s) suggestive of bacterial pneumonia in X-ray/ Chest CT.
5. Female subjects of childbearing potential, who are willing to birth control during the study and for at least 30 days following the last dose of study medication. Male subjects with female sexual partners of childbearing potential are eligible for inclusion if they agree to use birth control for 90 days following the last dose of study medication. Male subjects must agree not to donate sperm
Exclusion Criteria
2. Have known or suspected community-acquired bacterial pneumonia, atypical pneumonia, viral pneumonia including Coronavirus disease, or chemical pneumonia.
3. Have HABP/VABP caused by an obstructive process, including lung cancer or other known obstruction.
4. Have received effective antibacterial drug therapy for the index infection of HABP/VABP for more than 24 hours during the previous 72 hours .
5. Have central nervous system infection.
6. Documented presence of immunodeficiency or an immunocompromised condition
7. 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.
8. History of a seizure disorder requiring ongoing treatment with anti-convulsive therapy or prior treatment with anti-convulsive therapy within the last 3 years.
9. eGFR \<15 mL/min/1.73㎡.
10. Patient is receiving hemodialysis or peritoneal dialysis.
11. 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.
12. Life expectancy is \<3 days.
13. Patients in refractory septic shock
14. Patients with 1 or more of laboratory abnormalities in baseline specimens.
15. History of active liver disease or cirrhosis.
16. APACHE II score of \>30.
17. A female who is pregnant or breastfeeding or has a positive pregnancy test at Screening.
18 Years
ALL
No
Sponsors
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Evopoint Biosciences Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Jason Le
Role: STUDY_CHAIR
Evopoint Biosciences USA, Inc.)
Locations
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Denver Health and Hospital Authority
Denver, Colorado, United States
Hartford Hospital
Hartford, Connecticut, United States
Jackson Memorial Hospital (JMH) - Ryder Trauma Center
Miami, Florida, United States
USF-TGH
Tampa, Florida, United States
University of Maryland Medical Center
Baltimore, Maryland, United States
Cox Health
Springfield, Missouri, United States
VA medical center
Buffalo, New York, United States
Carolinas Medical Center
Charlotte, North Carolina, United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States
The University of Tennessee Medical Center
Knoxville, Tennessee, United States
CHU de Nice
Nice, Alpes Maritimes, France
Hôpitaux Universitaires de Strasbourg
Strasbourg, Alsace, France
Nouvel Hopital CIVIL/ Medecine Intensive Reanimation
Strasbourg, Bas-Rhin, France
Chu Nimes
Nîmes, GARD, France
Chu Reims- Medical Icu
Reims, Grand Est, France
Cochin
Paris, Paris, France
Groupe Hospitalier Paris Saint-Joseph
Paris, Paris, France
APHP
Paris, Paris, France
intensive Unit Care CHU Amiens Picardie
Amiens, Picardie, France
CH victor dupouy
Argenteuil, , France
Hôpital Foch
Suresnes, Île-de-France Region, France
Sheba Medical Center
Ramat Gan, Center, Israel
Wolfson Medical Center
H̱olon, Central District, Israel
Bnei-Zion Medical Center
Haifa, Haifa District, Israel
Shamir Medical Center
Be’er Ya‘aqov, HaMercaz, Israel
Hillel Yaffe Medical Center
Hadera, Israel, Israel
Rambam Critical Care division
Haifa, Israel, Israel
Tel Aviv Medical Center
Tel Aviv, Israel, Israel
Galilee Medical Center / Department int med A
Nahariya, Western Galilee, Israel
Hospital del Mar
Barcelona, Barcelona, Spain
Hospital Universitari Vall Hebron
Barcelona, Barcelona, Spain
Hospital Clínic of Barcelona
Barcelona, Barcelona, Spain
Hospital de la Santa Creu i Sant Pau
Barcelona, Barcelona, Spain
Bellvitge University Hospital
L'Hospitalet de Llobregat, Barcelona, Spain
Hospital Universitario de Tarragona Joan XXIII
Tarragona, Tarragona, Spain
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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XNW4107-302
Identifier Type: -
Identifier Source: org_study_id