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New antibiotic cocktail aims to beat tough hospital pneumonia

NCT ID NCT05204563

Disease control Sponsor: Evopoint Biosciences Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a new antibiotic combination (IMI-XNW4107) against an existing one (IMI/REL) in 450 adults with serious pneumonia caught in the hospital or from a ventilator. The main goal was to see if the new drug was at least as good at preventing death within 14 days. Both treatments are given through an IV and aim to control the infection.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

450 people

The number who actually took part.

Started

Jul 2022

Finished

Sep 2024

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. 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) 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: 1. Gram stain from a respiratory sample shows only Gram-positive cocci. 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.

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Conditions

The condition(s) this trial relates to.

nosocomial infection

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Hospital acquired bacterial pneumonia or ventilator-associated bacterial pneumonia

Contacts and locations

Locations

  • APHP

    Paris, Paris, 75018, France

  • Bellvitge University Hospital

    L'Hospitalet de Llobregat, Barcelona, 08907, Spain

  • Bnei-Zion Medical Center

    Haifa, Haifa District, 3339419, Israel

  • CH victor dupouy

    Argenteuil, 95100, France

  • CHU de Nice

    Nice, Alpes Maritimes, 06200, France

  • Carolinas Medical Center

    Charlotte, North Carolina, 28204, United States

  • Chu Nimes

    Nîmes, GARD, 30029, France

  • Chu Reims- Medical Icu

    Reims, Grand Est, 51100, France

  • Cochin

    Paris, Paris, 75014, France

  • Cox Health

    Springfield, Missouri, 65807, United States

  • Denver Health and Hospital Authority

    Denver, Colorado, 80204, United States

  • Galilee Medical Center / Department int med A

    Nahariya, Western Galilee, 2210001, Israel

  • Groupe Hospitalier Paris Saint-Joseph

    Paris, Paris, 75014, France

  • Hartford Hospital

    Hartford, Connecticut, 37920, United States

  • Hillel Yaffe Medical Center

    Hadera, Israel, 38100, Israel

  • Hospital Clínic of Barcelona

    Barcelona, Barcelona, 08036, Spain

  • Hospital Universitari Vall Hebron

    Barcelona, Barcelona, 08035, Spain

  • Hospital Universitario de Tarragona Joan XXIII

    Tarragona, Tarragona, 43007, Spain

  • Hospital de la Santa Creu i Sant Pau

    Barcelona, Barcelona, 08041, Spain

  • Hospital del Mar

    Barcelona, Barcelona, 08003, Spain

  • Hôpital Foch

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

  • Hôpitaux Universitaires de Strasbourg

    Strasbourg, Alsace, 67000, France

  • Jackson Memorial Hospital (JMH) - Ryder Trauma Center

    Miami, Florida, 33136, United States

  • Nouvel Hopital CIVIL/ Medecine Intensive Reanimation

    Strasbourg, Bas-Rhin, 67091, France

  • Rambam Critical Care division

    Haifa, Israel, 3525408, Israel

  • Shamir Medical Center

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

  • Sheba Medical Center

    Ramat Gan, Center, 5262100, Israel

  • Tel Aviv Medical Center

    Tel Aviv, Israel, 64239, Israel

  • The University of Tennessee Medical Center

    Knoxville, Tennessee, 37920, United States

  • USF-TGH

    Tampa, Florida, 33606, United States

  • University Hospitals Cleveland Medical Center

    Cleveland, Ohio, 44106, United States

  • University of Maryland Medical Center

    Baltimore, Maryland, 21201, United States

  • VA medical center

    Buffalo, New York, 14215, United States

  • Wolfson Medical Center

    H̱olon, Central District, 58100, Israel

  • intensive Unit Care CHU Amiens Picardie

    Amiens, Picardie, 80054, France

More trials for these conditions

Other studies related to the condition(s) this trial covers.