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New antibiotic cocktails take on tough UTIs and kidney infections

NCT ID NCT05887908

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This phase 3 trial tested two new antibiotic combinations—cefepime/nacubactam and aztreonam/nacubactam—against a standard antibiotic (imipenem/cilastatin) in 614 adults with complicated urinary tract infections or acute kidney infections. The goal was to see if the new combos are safe and effective at clearing both symptoms and bacteria. Results are pending.

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, these new antibiotic combos could offer effective treatment options for complicated urinary tract and kidney infections, especially against drug-resistant bacteria.
What could go wrong
This is a phase 3 trial, but results are not yet published. The new drugs may not prove superior or even non-inferior to the existing antibiotic, and side effects or resistance could limit their use.

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

614 people

The number who actually took part.

Started

May 2023

Finished

Nov 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. Male or female patients at least18 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. Expectation, in the opinion of the Investigator, that the patient's cUTI or AP will require treatment with at least 5 days of IV antibiotics; Exclusion Criteria: 1. Has a known imipenem- and/or meropenem-resistant Gram-negative uropathogen (at least 10\^5 CFU/mL), isolated from study-qualifying urine culture; Note: If after randomization the susceptibility testing indicates resistance to imipenem and/or meropenem, the patient may remain on the study drug at the Investigator's discretion. 2. Has known or suspected single or concurrent infection with Acinetobacter spp. or other organisms that are not adequately covered by the study drug (eg, concurrent viral, mycobacterial, or fungal infection) and needs to be managed with other anti-infectives; Note: Patients with qualifying pathogen coinfected 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 Investigator's discretion. 3. Has only a known Gram-positive primary uropathogen (at least 10\^5 CFU/mL), isolated from study qualifying urine culture;

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Conditions

The condition(s) this trial relates to.

acute pyelonephritis bacterial urinary tract infection cutis laxa

As listed by the trial registrant

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

Acute pyelonephritis AP Complicated urinary tract infection CUTI

Contacts and locations

Locations

  • Meiji Research Site

    Pleven, Bulgaria

  • Meiji Research Site

    Rousse, Bulgaria

  • Meiji Research Site

    Silistra, Bulgaria

  • Meiji Research Site

    Sofia, Bulgaria

  • Meiji Research Site

    Beijing, China

  • Meiji Research Site

    Changchun, China

  • Meiji Research Site

    Chongqing, China

  • Meiji Research Site

    Fuyang, China

  • Meiji Research Site

    Ganzhou, China

  • Meiji Research Site

    Huaian, China

  • Meiji Research Site

    Huzhou, China

  • Meiji Research Site

    Nanchang, China

  • Meiji Research Site

    Nanning, China

  • Meiji Research Site

    Quanzhou, China

  • Meiji Research Site

    Shanghai, China

  • Meiji Research Site

    Shantou, China

  • Meiji Research Site

    Shijiazhuang, China

  • Meiji Research Site

    Taian, China

  • Meiji Research Site

    Tianjin, China

  • Meiji Research Site

    Xuancheng, China

  • Meiji Research Site

    Yunnan, China

  • Meiji Research Site

    Zhejiang, China

  • Meiji Research Site

    Zhengzhou, China

  • Meiji Research Site

    Hradec Králové, Czechia

  • Meiji Research Site

    Liberec, Czechia

  • Meiji Research Site

    Prague, Czechia

  • Meiji Research Site

    Ústí nad Labem, Czechia

  • Meiji Research Site

    Meegomäe, Võrumaa, Estonia

  • Meiji Research Site

    Kohtla-Järve, Estonia

  • Meiji Research Site

    Tallinn, Estonia

  • Meiji Research Site

    Tartu, Estonia

  • Meiji Research Site

    Kutaisi, Georgia

  • Meiji Research Site

    Rustavi, Georgia

  • Meiji Research Site

    Tbilisi, Georgia

  • Meiji Research Site

    Fukuyama, Japan

  • Meiji Research Site

    Gifu, Japan

  • Meiji Research Site

    Ibaraki-Town, Higashiibaraki-County, Japan

  • Meiji Research Site

    Iwakuni, Japan

  • Meiji Research Site

    Kanazawa, Japan

  • Meiji Research Site

    Kawachi-Nagano, Japan

  • Meiji Research Site

    Kofu, Japan

  • Meiji Research Site

    Kumamoto, Japan

  • Meiji Research Site

    Matsumoto, Japan

  • Meiji Research Site

    Mizumaki-Town, Onga-County, Japan

  • Meiji Research Site

    Nagasaki, Japan

  • Meiji Research Site

    Nankoku, Japan

  • Meiji Research Site

    Ōita, Japan

  • Meiji Research Site

    Ōtake, Japan

  • Meiji Research Site

    Sagamihara, Japan

  • Meiji Research Site

    Sapporo, Japan

  • Meiji Research Site

    Shinjuku-ku, Japan

  • Meiji Research Site

    Toyota, Japan

  • Meiji Research Site

    Ueda, Japan

  • Meiji Research Site

    Yokohama, Japan

  • Meiji Research Site

    Riga, Latvia

  • Meiji Research Site

    Valmiera, Latvia

  • Meiji Research Site

    Kaunas, Lithuania

  • Meiji Research Site

    Vilnius, Lithuania

  • Meiji Research Site

    Galanta, Slovakia

  • Meiji Research Site

    Rimavská Sobota, Slovakia

  • Meiji Research Site

    Svidník, Slovakia

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