Hospital Acquired Bacterial Pneumonia or Ventilator-Associated Bacterial PneumoniaPhase 3REITAB-2NCT05204563
Imipenem/Cilastatin-XNW4107 Versus Imipenem/Cilastatin/Relebactam for Treatment of Participants With Bacterial Pneumonia (XNW4107-302, REITAB-2)
A Phase 3 study testing Combination of Imipenem/Cilastatin and XNW4107 and Imipenem/Cilastatin/Relebactam in people with Hospital Acquired Bacterial Pneumonia or Ventilator-Associated Bacterial Pneumonia, run by Evopoint Biosciences Inc. at 35 sites in 4 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hospital Acquired Bacterial Pneumonia or Ventilator-Associated Bacterial Pneumonia
- What is being tested?
- Combination of Imipenem/Cilastatin and XNW4107 and Imipenem/Cilastatin/Relebactam
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 450 participants
- Where
- 35 sitesin 4 countries
- Study dates
- 31 Jul 2022to 29 Sep 2024
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- 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
Who cannot join
- 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
Show all 17Show fewer
- 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.
- APACHE II score of >30.
- A female who is pregnant or breastfeeding or has a positive pregnancy test at Screening.
Trial locations and contacts
35 sites in 4 countries.
35 sites in 4 countries
France11 sites
intensive Unit Care CHU Amiens Picardie
Amiens, Picardie, 80054
CH victor dupouy
Argenteuil, 95100
CHU de Nice
Nice, Alpes Maritimes, 06200
Chu Nimes
Nîmes, GARD, 30029
Cochin
Paris, Paris, 75014
Groupe Hospitalier Paris Saint-Joseph
Paris, Paris, 75014
APHP
Paris, Paris, 75018
Chu Reims- Medical Icu
Reims, Grand Est, 51100
Hôpitaux Universitaires de Strasbourg
Strasbourg, Alsace, 67000
Nouvel Hopital CIVIL/ Medecine Intensive Reanimation
Strasbourg, Bas-Rhin, 67091
Hôpital Foch
Suresnes, Île-de-France Region, 92150
United States10 sites
University of Maryland Medical Center
Baltimore, Maryland, 21201
VA medical center
Buffalo, New York, 14215
Carolinas Medical Center
Charlotte, North Carolina, 28204
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106
Denver Health and Hospital Authority
Denver, Colorado, 80204
Hartford Hospital
Hartford, Connecticut, 37920
The University of Tennessee Medical Center
Knoxville, Tennessee, 37920
Jackson Memorial Hospital (JMH) - Ryder Trauma Center
Miami, Florida, 33136
Cox Health
Springfield, Missouri, 65807
USF-TGH
Tampa, Florida, 33606
Israel8 sites
Shamir Medical Center
Be’er Ya‘aqov, HaMercaz, 70300
Hillel Yaffe Medical Center
Hadera, Israel, 38100
Bnei-Zion Medical Center
Haifa, Haifa District, 3339419
Rambam Critical Care division
Haifa, Israel, 3525408
Wolfson Medical Center
H̱olon, Central District, 58100
Galilee Medical Center / Department int med A
Nahariya, Western Galilee, 2210001
Sheba Medical Center
Ramat Gan, Center, 5262100
Tel Aviv Medical Center
Tel Aviv, Israel, 64239
Spain6 sites
Hospital del Mar
Barcelona, Barcelona, 08003
Hospital Universitari Vall Hebron
Barcelona, Barcelona, 08035
Hospital Clínic of Barcelona
Barcelona, Barcelona, 08036
Hospital de la Santa Creu i Sant Pau
Barcelona, Barcelona, 08041
Bellvitge University Hospital
L'Hospitalet de Llobregat, Barcelona, 08907
Hospital Universitario de Tarragona Joan XXIII
Tarragona, Tarragona, 43007
About this study
Official title: 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)
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.
- Being tested
- Combination of Imipenem/Cilastatin and XNW4107, Imipenem/Cilastatin/Relebactam
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Combination of Imipenem/Cilastatin and XNW4107Drug
Imipenem/Cilastatin 500mg/500mg and XNW4107 250mg for Injection
Imipenem/Cilastatin/RelebactamDrug
Also called Recarbrio
Imipenem/Cilastatin/Relebactam 1.25 g for Injection
| Study group | Role | What they receive |
|---|---|---|
| Imipenem/Cilastatin/XNW4107 | Experimental | Imipenem/Cilastatin 500mg/500mg in combination with XNW4107 250mg, Q6h (0.5h Infusion) Receives: Drug: Combination of Imipenem/Cilastatin and XNW4107 |
| Imipenem/Cilastatin/Relebactam | Active comparator | Imipenem/Cilastatin/Relebactam 1.25g Q6h (0.5h Infusion) Receives: Drug: Imipenem/Cilastatin/Relebactam |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 14
Secondary outcomes (26)
Day 28 All-cause Mortality Rate
The all-cause mortality rate at Day 28 was calculated as the percentage of participants in each treatment group who experienced mortality, regardless of the cause, from randomization up to Day 28.
Measured: Day 28
Day 14 and Day 28 All-cause Mortality Rate in the Micro-MITT Population
The all-cause mortality rate at Day 14 and Day 28 was calculated as the percentage of participants in each treatment group who experienced mortality, regardless of the cause, from randomization up to Day 14 and Day 28.
Measured: Day 14, Day 28
Day 14 and Day 28 All-cause Mortality Rate in the Extended Micro-MITT
The all-cause mortality rate at Day 14 and Day 28 was calculated as the percentage of participants in each treatment group who experienced mortality, regardless of the cause, from randomization up to Day 14 and Day 28.
Measured: Day 14, Day 28
Day 14 and Day 28 All-cause Mortality Rate in the Clinically Evaluable (CE) Population
The all-cause mortality rate at Day 14 and Day 28 was calculated as the percentage of participants in each treatment group who experienced mortality, regardless of the cause, from randomization up to Day 14 and Day 28.
Measured: Day 14, Day 28
Day 14 and Day 28 All-cause Mortality Rate in the Microbiologically Evaluable (ME) Population
The all-cause mortality rate at Day 14 and Day 28 was calculated as the percentage of participants in each treatment group who experienced mortality, regardless of the cause, from randomization up to Day 14 and Day 28.
Measured: Day 14, Day 28
Day 14 and Day 28 All-cause Mortality Rate in the Carbapenem-resistant MITT (CR-MITT) Population
The all-cause mortality rate at Day 14 and Day 28 was calculated as the percentage of participants in each treatment group who experienced mortality, regardless of the cause, from randomization up to Day 14 and Day 28.
Measured: Day 14, Day 28
The Percentage of Participants With Clinical Success as Evaluated by the Investigator in the MITT Population
Clinical success was defined as: For Day 4 visit: a participant was alive with resolution or improvement in at least 1 baseline sign/symptom AND no worsening of any baseline signs/symptoms AND no development of new signs/symptoms of pneumonia requiring the initiation of a non-study antibacterial therapy for the index infection. For end of treatment (EOT) or test-of-cure (TOC) visits: a participant was alive with complete resolution or significant improvement of signs and symptoms that were present at baseline and no new signs/symptoms of pneumonia, such that no further antibacterial therapy is necessary. For LFU, Clinical success at TOC with sustained resolution or marked improvement of baseline signs and symptoms of pneumonia during TOC and LFU without antimicrobial therapy (pneumonia).
Measured: Day 4, end of treatment (EOT) (up to Day 14), Test-of-Cure (TOC) (Day 21), and Late Follow-up (LFU) (Day 28)
The Percentage of Participants With Clinical Success as Evaluated by the Investigator in the Micro-MITT Population
Clinical success was defined as: For Day 4 visit: a participant was alive with resolution or improvement in at least 1 baseline sign/symptom AND no worsening of any baseline signs/symptoms AND no development of new signs/symptoms of pneumonia requiring the initiation of a non-study antibacterial therapy for the index infection. For EOT or TOC visits: a participant was alive with complete resolution or significant improvement of signs and symptoms that were present at baseline and no new signs/symptoms of pneumonia, such that no further antibacterial therapy is necessary. For LFU, Clinical success at TOC with sustained resolution or marked improvement of baseline signs and symptoms of pneumonia during TOC and LFU without antimicrobial therapy (pneumonia).
Measured: Day 4, EOT (up to Day 14), TOC (Day 21), and LFU (Day 28)
The Percentage of Participants With Clinical Success as Evaluated by the Investigator in the Extended Micro-MITT
Clinical success was defined as: For Day 4 visit: a participant was alive with resolution or improvement in at least 1 baseline sign/symptom AND no worsening of any baseline signs/symptoms AND no development of new signs/symptoms of pneumonia requiring the initiation of a non-study antibacterial therapy for the index infection. For EOT or TOC visits: a participant was alive with complete resolution or significant improvement of signs and symptoms that were present at baseline and no new signs/symptoms of pneumonia, such that no further antibacterial therapy is necessary. For LFU, Clinical success at TOC with sustained resolution or marked improvement of baseline signs and symptoms of pneumonia during TOC and LFU without antimicrobial therapy (pneumonia).
Measured: Day 4, EOT (up to Day 14), TOC (Day 21), and LFU (Day 28)
The Percentage of Participants With Clinical Success as Evaluated by the Investigator in the CE Population
Clinical success was defined as: For Day 4 visit: a participant was alive with resolution or improvement in at least 1 baseline sign/symptom AND no worsening of any baseline signs/symptoms AND no development of new signs/symptoms of pneumonia requiring the initiation of a non-study antibacterial therapy for the index infection. For EOT or TOC visits: a participant was alive with complete resolution or significant improvement of signs and symptoms that were present at baseline and no new signs/symptoms of pneumonia, such that no further antibacterial therapy is necessary. For LFU, Clinical success at TOC with sustained resolution or marked improvement of baseline signs and symptoms of pneumonia during TOC and LFU without antimicrobial therapy (pneumonia).
Measured: Day 4, end of treatment (EOT) (up to Day 14), Test-of-Cure (TOC) (Day 21), and Late Follow-up (LFU) (Day 28)
The Percentage of Participants With Clinical Success as Evaluated by the Investigator in the ME Population
Clinical success was defined as: For Day 4 visit: a participant was alive with resolution or improvement in at least 1 baseline sign/symptom AND no worsening of any baseline signs/symptoms AND no development of new signs/symptoms of pneumonia requiring the initiation of a non-study antibacterial therapy for the index infection. For EOT or TOC visits: a participant was alive with complete resolution or significant improvement of signs and symptoms that were present at baseline and no new signs/symptoms of pneumonia, such that no further antibacterial therapy is necessary. For LFU, Clinical success at TOC with sustained resolution or marked improvement of baseline signs and symptoms of pneumonia during TOC and LFU without antimicrobial therapy (pneumonia).
Measured: Day 4, end of treatment (EOT) (up to Day 14), Test-of-Cure (TOC) (Day 21), and Late Follow-up (LFU) (Day 28)
The Percentage of Participants With Clinical Success as Evaluated by the Investigator in the CR-MITT Population
Clinical success was defined as: For Day 4 visit: a participant was alive with resolution or improvement in at least 1 baseline sign/symptom AND no worsening of any baseline signs/symptoms AND no development of new signs/symptoms of pneumonia requiring the initiation of a non-study antibacterial therapy for the index infection. For EOT or TOC visits: a participant was alive with complete resolution or significant improvement of signs and symptoms that were present at baseline and no new signs/symptoms of pneumonia, such that no further antibacterial therapy is necessary. For LFU, Clinical success at TOC with sustained resolution or marked improvement of baseline signs and symptoms of pneumonia during TOC and LFU without antimicrobial therapy (pneumonia).
Measured: Day 4, end of treatment (EOT) (up to Day 14), Test-of-Cure (TOC) (Day 21), and Late Follow-up (LFU) (Day 28)
The Percentage of Participants With Microbiological Success in the Micro-MITT Population
Microbiological success was defined as: • Eradication: Absence of the baseline Gram-negative pathogen from an appropriate clinical specimen • Presumed eradication: Absence of appropriate post-baseline culture material in a participant, but judged to be a clinical success.
Measured: EOT (up to Day 14), TOC (Day 21), and LFU (Day 28)
The Percentage of Participants With Microbiological Success in the Extended Micro-MITT Population
Microbiological success was defined as: • Eradication: Absence of the baseline Gram-negative pathogen from an appropriate clinical specimen • Presumed eradication: Absence of appropriate post-baseline culture material in a participant, but judged to be a clinical success.
Measured: EOT (up to Day 14), TOC (Day 21), and LFU (Day 28)
The Percentage of Participants With Microbiological Success in the CR-MITT Population
Microbiological success was defined as: • Eradication: Absence of the baseline Gram-negative pathogen from an appropriate clinical specimen • Presumed eradication: Absence of appropriate post-baseline culture material in a participant, but judged to be a clinical success.
Measured: EOT (up to Day 14), TOC (Day 21), and LFU (Day 28)
The Percentage of Participants With Microbiological Success in the ME Population
Microbiological success was defined as: • Eradication: Absence of the baseline Gram-negative pathogen from an appropriate clinical specimen • Presumed eradication: Absence of appropriate post-baseline culture material in a participant, but judged to be a clinical success.
Measured: EOT (up to Day 14), TOC (Day 21), and LFU (Day 28)
The Percentage of Participants With Microbiological Success by Pathogen in the Micro-MITT Population
Microbiological success was defined as: • Eradication: Absence of the baseline Gram-negative pathogen from an appropriate clinical specimen • Presumed eradication: Absence of appropriate post-baseline culture material in a participant, but judged to be a clinical success.
Measured: EOT (up to Day 14), TOC (Day 21), and LFU (Day 28)
The Percentage of Participants With Microbiological Success by Pathogen in the Extended Micro-MITT Population
Microbiological success was defined as: • Eradication: Absence of the baseline Gram-negative pathogen from an appropriate clinical specimen • Presumed eradication: Absence of appropriate post-baseline culture material in a participant, but judged to be a clinical success.
Measured: EOT (up to Day 14), TOC (Day 21), and LFU (Day 28)
The Percentage of Participants With Microbiological Success by Pathogen in the ME Population
Microbiological success was defined as: • Eradication: Absence of the baseline Gram-negative pathogen from an appropriate clinical specimen • Presumed eradication: Absence of appropriate post-baseline culture material in a participant, but judged to be a clinical success.
Measured: EOT (up to Day 14), TOC (Day 21), and LFU (Day 28)
The Percentage of Participants With Microbiological Success by Pathogen in the CR-MITT Population
Microbiological success was defined as: • Eradication: Absence of the baseline Gram-negative pathogen from an appropriate clinical specimen • Presumed eradication: Absence of appropriate post-baseline culture material in a participant, but judged to be a clinical success.
Measured: EOT (up to Day 14), TOC (Day 21), and LFU (Day 28)
The Percentage of Participants With Overall Success in the Micro-MITT Population
Overall success was defined as clinical success and microbiological success at the visits of EOT or TOC, or sustained success for clinical outcome and microbiological success at the visit of LFU. Microbiological success included eradication or presumed eradication.
Measured: EOT (up to Day 14), TOC (Day 21), and LFU (Day 28)
The Percentage of Participants With Overall Success in the Extended Micro-MITT Population
Overall success was defined as clinical success and microbiological success at the visits of EOT or TOC, or sustained success for clinical outcome and microbiological success at the visit of LFU. Microbiological success included eradication or presumed eradication.
Measured: EOT (up to Day 14), TOC (Day 21), and LFU (Day 28)
The Percentage of Participants With Overall Success in the ME Population
Overall success was defined as clinical success and microbiological success at the visits of EOT or TOC, or sustained success for clinical outcome and microbiological success at the visit of LFU. Microbiological success included eradication or presumed eradication.
Measured: EOT (up to Day 14), TOC (Day 21), and LFU (Day 28)
The Percentage of Participants With Overall Success in the CR-MITT Population
Overall success was defined as clinical success and microbiological success at the visits of EOT or TOC, or sustained success for clinical outcome and microbiological success at the visit of LFU. Microbiological success included eradication or presumed eradication.
Measured: EOT (up to Day 14), TOC (Day 21), and LFU (Day 28)
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
A TEAE was defined as any untoward medical occurrence after first dose associated with the use of a drug in humans, whether or not considered drug-related. An SAE was defined as any adverse event (AE) occurring at any dose that met one or more of the following criteria: resulted in death, was life-threatening, required participant hospitalization or prolongation of an existing hospitalization, resulted in persistent or significant disability or incapacity, a congenital anomaly or birth defect or an important medical event.
Measured: Day 1 to Day 28
Blood XNW4107, Imipenem, and Cilastatin Concentrations
Blood samples were taken for analysis of XNW4107, imipenem, and cilastatin concentrations. The data at each time point was calculated as an average across Days 4, 5 and 6.
Measured: Predose, 5-25 minutes post-dose, and 2-3 hours post-dose on Day 4, 5, or 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2022
- Study start31 Jul 2022
- Primary completion29 Sep 2024
- Study completion29 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hospital Acquired Bacterial Pneumonia or Ventilator-Associated Bacterial PneumoniaStudies of the same condition, open and under way.
- More trials run by Evopoint Biosciences Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 450 participants (actual)
Sponsor and investigators
- Lead sponsor
- Evopoint Biosciences Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jason Le, Study chair, Evopoint Biosciences USA, Inc.)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05204563
- Sponsor's protocol ID
- XNW4107-302
- Acronym
- REITAB-2
- Status last verified
- Oct 2025
- First submitted
- 5 Jan 2022
- Last updated
- 6 Nov 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Chang K, Wang Y, Wang C, Tang Z, Yin J, Zhao J, Wang Y, Mei T, Li A, Li H, Jiang Q, Wang P, Ye F, Ding L, Liu Z, Yin F, Mo X, Qu H, Xia Y, Wang J, Wu J, Yang S, Lin R, Lv G, Luo H, Liu B, Gu J, Wei F, Zhu J, Liang H, Qiu S, Mai H, Zhu X, Yu R, Han G, Lou T, Wang H, Zhang J, Li Y, Wang H, Lu H, Xin T, Li C, Wang X, Zhang X, Gao H, Wang H, Pan A, Wang Q, Cao J, Zhu Y, Xiao Z, Pan L, Peng S, Ding X, Chi Q, Xu H, Liu F, Guo A, Zhan J, Zhang Q, Guo R, Huynh T, Biney I, Remy KE, Yuste AC, Li J, Zhu D, Zhao H, Cao B. Imipenem-cilastatin-funobactam versus imipenem-cilastatin-relebactam in patients with hospital-acquired bacterial pneumonia or ventilator-associated bacterial pneumonia: a phase 3, double-blind, non-inferiority randomised trial. Lancet Infect Dis. 2026 Nov 4:S1473-3099(26)00520-7. doi: 10.1016/S1473-3099(26)00520-7. Online ahead of print.
PubMed 42982070
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT05204563
- Acronym / sponsor ID
- REITAB-2 / XNW4107-302
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 450 participants (actual)
- Lead sponsor
- Evopoint Biosciences Inc.Industry (pharma, biotech, devices)
- Study start
- 31 Jul 2022 (actual)
- Primary completion
- 29 Sep 2024 (actual)
- Study completion
- 29 Sep 2024 (actual)
- First posted
- 24 Jan 2022 (actual)
- Results
- Posted 6 Nov 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Imipenem/Cilastatin/XNW4107 | Experimental | Drug: Combination of Imipenem/Cilastatin and XNW4107Imipenem/Cilastatin 500mg/500mg in combination with XNW4107 250mg, Q6h (0.5h Infusion) |
| Imipenem/Cilastatin/Relebactam | Active comparator | Drug: Imipenem/Cilastatin/RelebactamImipenem/Cilastatin/Relebactam 1.25g Q6h (0.5h Infusion) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
- 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
Key exclusion criteria (17 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Combination of Imipenem/Cilastatin and XNW4107Imipenem/Cilastatin 500mg/500mg and XNW4107 250mg for Injection | Drug | Imipenem/Cilastatin/XNW4107 |
| Imipenem/Cilastatin/RelebactamAlso: RecarbrioImipenem/Cilastatin/Relebactam 1.25 g for Injection | Drug | Imipenem/Cilastatin/Relebactam |
Primary outcome
Day 14 All-cause Mortality Rate
Time frame: Day 14
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.
26 secondary outcomes
Day 28 All-cause Mortality Rate
Time frame: Day 28
Day 14 and Day 28 All-cause Mortality Rate in the Micro-MITT Population
Time frame: Day 14, Day 28
Day 14 and Day 28 All-cause Mortality Rate in the Extended Micro-MITT
Time frame: Day 14, Day 28
Day 14 and Day 28 All-cause Mortality Rate in the Clinically Evaluable (CE) Population
Time frame: Day 14, Day 28
Day 14 and Day 28 All-cause Mortality Rate in the Microbiologically Evaluable (ME) Population
Time frame: Day 14, Day 28
Day 14 and Day 28 All-cause Mortality Rate in the Carbapenem-resistant MITT (CR-MITT) Population
Time frame: Day 14, Day 28
The Percentage of Participants With Clinical Success as Evaluated by the Investigator in the MITT Population
Time frame: Day 4, end of treatment (EOT) (up to Day 14), Test-of-Cure (TOC) (Day 21), and Late Follow-up (LFU) (Day 28)
The Percentage of Participants With Clinical Success as Evaluated by the Investigator in the Micro-MITT Population
Time frame: Day 4, EOT (up to Day 14), TOC (Day 21), and LFU (Day 28)
The Percentage of Participants With Clinical Success as Evaluated by the Investigator in the Extended Micro-MITT
Time frame: Day 4, EOT (up to Day 14), TOC (Day 21), and LFU (Day 28)
The Percentage of Participants With Clinical Success as Evaluated by the Investigator in the CE Population
Time frame: Day 4, end of treatment (EOT) (up to Day 14), Test-of-Cure (TOC) (Day 21), and Late Follow-up (LFU) (Day 28)
The Percentage of Participants With Clinical Success as Evaluated by the Investigator in the ME Population
Time frame: Day 4, end of treatment (EOT) (up to Day 14), Test-of-Cure (TOC) (Day 21), and Late Follow-up (LFU) (Day 28)
The Percentage of Participants With Clinical Success as Evaluated by the Investigator in the CR-MITT Population
Time frame: Day 4, end of treatment (EOT) (up to Day 14), Test-of-Cure (TOC) (Day 21), and Late Follow-up (LFU) (Day 28)
The Percentage of Participants With Microbiological Success in the Micro-MITT Population
Time frame: EOT (up to Day 14), TOC (Day 21), and LFU (Day 28)
The Percentage of Participants With Microbiological Success in the Extended Micro-MITT Population
Time frame: EOT (up to Day 14), TOC (Day 21), and LFU (Day 28)
The Percentage of Participants With Microbiological Success in the CR-MITT Population
Time frame: EOT (up to Day 14), TOC (Day 21), and LFU (Day 28)
The Percentage of Participants With Microbiological Success in the ME Population
Time frame: EOT (up to Day 14), TOC (Day 21), and LFU (Day 28)
The Percentage of Participants With Microbiological Success by Pathogen in the Micro-MITT Population
Time frame: EOT (up to Day 14), TOC (Day 21), and LFU (Day 28)
The Percentage of Participants With Microbiological Success by Pathogen in the Extended Micro-MITT Population
Time frame: EOT (up to Day 14), TOC (Day 21), and LFU (Day 28)
The Percentage of Participants With Microbiological Success by Pathogen in the ME Population
Time frame: EOT (up to Day 14), TOC (Day 21), and LFU (Day 28)
The Percentage of Participants With Microbiological Success by Pathogen in the CR-MITT Population
Time frame: EOT (up to Day 14), TOC (Day 21), and LFU (Day 28)
The Percentage of Participants With Overall Success in the Micro-MITT Population
Time frame: EOT (up to Day 14), TOC (Day 21), and LFU (Day 28)
The Percentage of Participants With Overall Success in the Extended Micro-MITT Population
Time frame: EOT (up to Day 14), TOC (Day 21), and LFU (Day 28)
The Percentage of Participants With Overall Success in the ME Population
Time frame: EOT (up to Day 14), TOC (Day 21), and LFU (Day 28)
The Percentage of Participants With Overall Success in the CR-MITT Population
Time frame: EOT (up to Day 14), TOC (Day 21), and LFU (Day 28)
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Time frame: Day 1 to Day 28
Blood XNW4107, Imipenem, and Cilastatin Concentrations
Time frame: Predose, 5-25 minutes post-dose, and 2-3 hours post-dose on Day 4, 5, or 6
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 42982070Chang K, Wang Y, Wang C, Tang Z, Yin J, Zhao J, Wang Y, Mei T, Li A, Li H, Jiang Q, Wang P, Ye F, Ding L, Liu Z, Yin F, Mo X, Qu H, Xia Y, Wang J, Wu J, Yang S, Lin R, Lv G, Luo H, Liu B, Gu J, Wei F, Zhu J, Liang H, Qiu S, Mai H, Zhu X, Yu R, Han G, Lou T, Wang H, Zhang J, Li Y, Wang H, Lu H, Xin T, Li C, Wang X, Zhang X, Gao H, Wang H, Pan A, Wang Q, Cao J, Zhu Y, Xiao Z, Pan L, Peng S, Ding X, Chi Q, Xu H, Liu F, Guo A, Zhan J, Zhang Q, Guo R, Huynh T, Biney I, Remy KE, Yuste AC, Li J, Zhu D, Zhao H, Cao B. Imipenem-cilastatin-funobactam versus imipenem-cilastatin-relebactam in patients with hospital-acquired bacterial pneumonia or ventilator-associated bacterial pneumonia: a phase 3, double-blind, non-inferiority randomised trial. Lancet Infect Dis. 2026 Nov 4:S1473-3099(26)00520-7. doi: 10.1016/S1473-3099(26)00520-7. Online ahead of print.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jason Le study chair
Evopoint Biosciences USA, Inc.)
35 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Combination of Imipenem/Cilastatin and XNW4107 and Imipenem/Cilastatin/Relebactam in people with Hospital Acquired Bacterial Pneumonia or Ventilator-Associated Bacterial Pneumonia, run by Evopoint Biosciences Inc. at 35 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 35 sites in France, United States, Israel, Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Nov 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Day 14 All-cause Mortality Rate (time frame: Day 14). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05204563, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2025.