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New antibiotic cocktail takes on superbugs in phase 3 trial

NCT ID NCT05905055

Disease control Sponsor: Meiji Seika Pharma Co., Ltd. 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested two new antibiotic combinations (cefepime/nacubactam and aztreonam/nacubactam) against the best available treatments for adults with serious infections like urinary tract infections, pneumonia, and abdominal infections caused by carbapenem-resistant bacteria. The trial enrolled 126 participants and compared how well each treatment worked and how safe it was. The goal was to see if these new combinations could successfully treat these hard-to-kill infections.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Cefepime/nacubactam and aztreonam/nacubactam (antibiotic combinations)
What this could lead to
If successful, this could provide new treatment options for serious infections that are resistant to many current antibiotics.
What could go wrong
This is a relatively small phase 3 trial (126 participants) and results may not apply to all patients. The new drug combinations may not work better than existing therapies and could have side effects.

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

126 people

The number who actually took part.

Started

Sep 2023

Finished

Sep 2025

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. Male or female patients at least 18 years of age (or age of legal consent, whichever is older) at the time of obtaining informed consent and who can be hospitalized throughout the Treatment Period; 2. Weight at most 140 kg; 3. The following criteria must be satisfied: a. For known CRE infection, meets either of the following (i or ii): i. Has a known CRE infection, alone or as a single isolate of a polymicrobial infection, based on evidence from CRE culture, susceptibility testing, and possible carbapenemase phenotypic testing (or possible molecular testing) within 72 hours (or 96 hours for cIAI) prior to the first dose of study drug; AND Has received no more than 24 hours of an antimicrobial agent to which the known CRE is known to be susceptible within 72 hours (or 96 hours for cIAI) prior to the first dose of study drug; OR ii. Has a known CRE infection, alone or as a single isolate of a polymicrobial infection, based on evidence from CRE culture, susceptibility testing, and possible carbapenemase phenotypic testing (or possible molecular testing) within 72 hours (or 96 hours for cIAI) prior to the first dose of study drug; AND Has documented clinical evidence of failure (ie, clinical deterioration or failure to improve) after at least 48 hours of treatment with an antimicrobial agent to which the known CRE is known to be susceptible within 72 hours (or 96 hours for cIAI) prior to the first dose of study drug; b. For suspected CRE infection, meets the following (i or ii): i. Has a suspected CRE infection, alone or as a single isolate of a polymicrobial infection, based on evidence which may be determined within 90 days prior to the first dose of study drug through rapid diagnostic tests, active surveillance cultures, other documentation of CRE colonization, or prior infection due to a CRE pathogen; AND Has received no more than 24 hours of empiric antimicrobial therapy for Gram negative organisms within 72 hours (or 96 hours for cIAI) prior to the first dose of study drug； ii. Has a suspected CRE infection, alone or as a single isolate of a polymicrobial infection, based on evidence which may be determined within 90 days prior to the first dose of study drug through rapid diagnostic tests, active surveillance cultures, other documentation of CRE colonization, or prior infection due to a CRE pathogen; AND Has documented clinical evidence of failure (ie, clinical deterioration or failure to improve) after at least 48 hours of treatment with empiric antimicrobial therapy for Gram-negative organisms within 72 hours (or 96 hours for cIAI) prior to the first dose of study drug; Note: CRE is defined as Enterobacterales by susceptibility data of MIC at least 2 microg/mL to imipenem or meropenem OR imipenem or meropenem disk diffusion (zone diameter \< 22 mm). If MIC or disk diffusion data are not available in the local laboratory or before the availability of MIC or disk diffusion results, each site can use other methods and criteria in the institution (eg, phenotypic or molecular testing) as the initial evidence of CRE for enrollment. In any case, pathogen identification and susceptibility testing performed at the central laboratory will be used to determine CRE in the final study analysis. Exclusion Criteria: 1. Has a history of serious allergy, hypersensitivity (eg, anaphylaxis), or any serious allergic reaction to carbapenems, cephems, penicillins, other beta-lactam antibiotics, or any BLIs (eg, tazobactam, sulbactam, or clavulanic acid) 2. Has known or suspected single or concurrent infection with Acinetobacter spp., metallo-β-lactamase (MBL) producing Pseudomonas aeruginosa, or other organisms that are not adequately covered by the study drug (eg, concurrent viral, mycobacterial, or fungal infection) and need to be managed with other anti-infectives; Note: Patients with qualifying Gram-negative pathogen co-infected with a Gram-positive pathogen may be administered narrow spectrum, open-label glycopeptide (eg, vancomycin), oxazolidinone (eg, linezolid), or daptomycin concomitantly with the study drug at the discretion of the Investigator. Patients with cIAI may receive metronidazole in addition to cefepime/nacubactam, aztreonam/nacubactam, or as part of BAT if anaerobic coverage is deemed necessary 3. Has only a Gram-positive organism pathogen isolated from study-qualifying culture;

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Conditions

The condition(s) this trial relates to.

acute pyelonephritis bacterial urinary tract infection infectious peritonitis nosocomial infection

As listed by the trial registrant

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

Acute pyelonephritis Complicated intra-abdominal infection Complicated urinary tract infection Hospital-acquired bacterial pneumonia Ventilator associated bacterial pneumonia

Contacts and locations

Locations

  • Meiji Research Site

    Changsha, China

  • Meiji Research Site

    Chongqing, China

  • Meiji Research Site

    Fuyang, China

  • Meiji Research Site

    Guangzhou, China

  • Meiji Research Site

    Hangzhou, China

  • Meiji Research Site

    Hefei, China

  • Meiji Research Site

    Nanjing, China

  • Meiji Research Site

    Nanning, China

  • Meiji Research Site

    Quanzhou, China

  • Meiji Research Site

    Shanghai, China

  • Meiji Research Site

    Shenzhen, China

  • Meiji Research Site

    Shijiazhuang, China

  • Meiji Research Site

    Wuxi, China

  • Meiji Research Site

    Xuzhou, China

  • Meiji Research Site

    Zagreb, Croatia

  • Meiji Research Site

    Kyjov, Czechia

  • Meiji Research Site

    Limoges, France

  • Meiji Research Site

    Nîmes, France

  • Meiji Research Site

    Paris, France

  • Meiji Research Site

    Strasbourg, France

  • Meiji Research Site

    Kutaisi, Georgia

  • Meiji Research Site

    Tbilisi, Georgia

  • Meiji Research Site

    Zestaponi, Georgia

  • Meiji Research Site

    Athens, Greece

  • Meiji Research Site

    Be’er Ya‘aqov, Israel

  • Meiji Research Site

    Ramat Gan, Israel

  • Meiji Research Site

    Tel Aviv, Israel

  • Meiji Research Site

    Nankoku, Kochi, Japan

  • Meiji Research Site

    Hiroshima, Japan

  • Meiji Research Site

    Kanazawa, Japan

  • Meiji Research Site

    Nagasaki, Japan

  • Meiji Research Site

    Nankoku, Japan

  • Meiji Research Site

    Ōta-ku, Japan

  • Meiji Research Site

    Shinjuku-ku, Japan

  • Meiji Research Site

    Toyoake, Japan

  • Meiji Research Site

    Daugavpils, Latvia

  • Meiji Research Site

    Liepāja, Latvia

  • Meiji Research Site

    Riga, Latvia

  • Meiji Research Site

    Valmiera, Latvia

  • Meiji Research Site

    Nitra, Slovakia

  • Meiji Research Site

    Svidník, Slovakia

  • Meiji Research Site

    Córdoba, Spain

  • Meiji Research Site

    Madrid, Spain

  • Meiji Research Site

    Kaohsiung City, Taiwan

  • Meiji Research Site

    Taichung, Taiwan

  • Meiji Research Site

    Taipei, Taiwan

  • Meiji Research Site

    Bangkok, Thailand

  • Meiji Research Site

    Chiang Mai, Thailand

  • Meiji Research Site

    Khon Kaen, Thailand

  • Meiji Research Site

    Ankara, Turkey (Türkiye)

  • Meiji Research Site

    Eskişehir, Turkey (Türkiye)

  • Meiji Research Site

    Istanbul, Turkey (Türkiye)

  • Meiji Research Site

    İzmit, Turkey (Türkiye)

  • Meiji Research Site

    Trabzon, Turkey (Türkiye)

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