Efficacy and Safety of Cefepime/Nacubactam or Aztreonam/Nacubactam Compared to Imipenem/Cilastatin in Subjects With Complicated Urinary Tract Infections or Acute Uncomplicated Pyelonephritis

Last updated: November 12, 2025
Sponsor: Meiji Seika Pharma Co., Ltd.
Overall Status: Completed

Phase

3

Condition

Urinary Tract Infections

Gynecological Infections

Nephritis

Treatment

imipenem/cilastatin

co-administration of aztreonam and nacubactam

co-administration of cefepime and nacubactam

Clinical Study ID

NCT05887908
OP0595-5
  • Ages > 18
  • All Genders

Study Summary

Phase 3 study to evaluate the efficacy and safety of cefepime/nacubactam or aztreonam/nacubactam compared to imipenem/cilastatin in the treatment of complicated urinary tract infections (cUTI) or acute uncomplicated pyelonephritis (AP).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Male or female patients at least18 years of age (or age of legal consent, whicheveris older) at the time of obtaining informed consent and who can be hospitalizedthroughout the Treatment Period;

  2. Weight at most 140 kg;

  3. Expectation, in the opinion of the Investigator, that the patient's cUTI or AP willrequire treatment with at least 5 days of IV antibiotics;

Exclusion

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 afterrandomization the susceptibility testing indicates resistance to imipenem and/ormeropenem, the patient may remain on the study drug at the Investigator'sdiscretion.

  2. Has known or suspected single or concurrent infection with Acinetobacter spp. orother organisms that are not adequately covered by the study drug (eg, concurrentviral, mycobacterial, or fungal infection) and needs to be managed with otheranti-infectives; Note: Patients with qualifying pathogen coinfected with aGram-positive pathogen may be administered narrow spectrum, open-label glycopeptide (eg, vancomycin), oxazolidinone (eg, linezolid), or daptomycin concomitantly withthe study drug at the Investigator's discretion.

  3. Has only a known Gram-positive primary uropathogen (at least 10^5 CFU/mL), isolatedfrom study qualifying urine culture;

Study Design

Total Participants: 614
Treatment Group(s): 3
Primary Treatment: imipenem/cilastatin
Phase: 3
Study Start date:
May 23, 2023
Estimated Completion Date:
November 26, 2024

Connect with a study center

  • Meiji Research Site

    Pleven 728203,
    Bulgaria

    Site Not Available

  • Meiji Research Site

    Rousse 727523,
    Bulgaria

    Site Not Available

  • Meiji Research Site

    Silistra 727221,
    Bulgaria

    Site Not Available

  • Meiji Research Site

    Sofia 727011,
    Bulgaria

    Site Not Available

  • Meiji Research Site

    Beijing 1816670,
    China

    Site Not Available

  • Meiji Research Site

    Changchun 2038180,
    China

    Site Not Available

  • Meiji Research Site

    Chongqing 1814906,
    China

    Site Not Available

  • Meiji Research Site

    Fuyang 1810845,
    China

    Site Not Available

  • Meiji Research Site

    Ganzhou 1810638,
    China

    Site Not Available

  • Meiji Research Site

    Huaian,
    China

    Site Not Available

  • Meiji Research Site

    Huzhou 1806535,
    China

    Site Not Available

  • Meiji Research Site

    Nanchang 1800163,
    China

    Site Not Available

  • Meiji Research Site

    Nanning 1799869,
    China

    Site Not Available

  • Meiji Research Site

    Quanzhou 1797353,
    China

    Site Not Available

  • Meiji Research Site

    Shanghai 1796236,
    China

    Site Not Available

  • Meiji Research Site

    Shantou 1795940,
    China

    Site Not Available

  • Meiji Research Site

    Shijiazhuang 1795270,
    China

    Site Not Available

  • Meiji Research Site

    Taian,
    China

    Site Not Available

  • Meiji Research Site

    Tianjin 1792947,
    China

    Site Not Available

  • Meiji Research Site

    Xuancheng 1788081,
    China

    Site Not Available

  • Meiji Research Site

    Yunnan 7059642,
    China

    Site Not Available

  • Meiji Research Site

    Zhejiang 9898779,
    China

    Site Not Available

  • Meiji Research Site

    Zhengzhou 1784658,
    China

    Site Not Available

  • Meiji Research Site

    Hradec Králové 3074967,
    Czechia

    Site Not Available

  • Meiji Research Site

    Liberec 3071961,
    Czechia

    Site Not Available

  • Meiji Research Site

    Prague 3067696,
    Czechia

    Site Not Available

  • Meiji Research Site

    Ústí nad Labem 3063548,
    Czechia

    Site Not Available

  • Meiji Research Site

    Meegomäe, Voru
    Estonia

    Site Not Available

  • Meiji Research Site

    Meegomäe 794304, Võrumaa 587448
    Estonia

    Site Not Available

  • Meiji Research Site

    Kohtla-Järve 591260,
    Estonia

    Site Not Available

  • Meiji Research Site

    Tallinn 588409,
    Estonia

    Site Not Available

  • Meiji Research Site

    Tartu 588335,
    Estonia

    Site Not Available

  • Meiji Research Site

    Kutaisi 613607,
    Georgia

    Site Not Available

  • Meiji Research Site

    Rustavi 612287,
    Georgia

    Site Not Available

  • Meiji Research Site

    Tbilisi 611717,
    Georgia

    Site Not Available

  • Meiji Research Site

    Fukuyama 1863917,
    Japan

    Site Not Available

  • Meiji Research Site

    Gifu 1863641,
    Japan

    Site Not Available

  • Meiji Research Site

    Ibaraki-Town, Higashiibaraki-County,
    Japan

    Site Not Available

  • Meiji Research Site

    Iwakuni 1861212,
    Japan

    Site Not Available

  • Meiji Research Site

    Kanazawa 1860243,
    Japan

    Site Not Available

  • Meiji Research Site

    Kawachi-Nagano 6825498,
    Japan

    Site Not Available

  • Meiji Research Site

    Kofu 1859100,
    Japan

    Site Not Available

  • Meiji Research Site

    Kumamoto 1858421,
    Japan

    Site Not Available

  • Meiji Research Site

    Matsumoto 1857519,
    Japan

    Site Not Available

  • Meiji Research Site

    Mizumaki-Town, Onga-County,
    Japan

    Site Not Available

  • Meiji Research Site

    Nagasaki 1856177,
    Japan

    Site Not Available

  • Meiji Research Site

    Nankoku 11612330,
    Japan

    Site Not Available

  • Meiji Research Site

    Sagamihara 11611609,
    Japan

    Site Not Available

  • Meiji Research Site

    Sapporo 2128295,
    Japan

    Site Not Available

  • Meiji Research Site

    Shinjuku-ku,
    Japan

    Site Not Available

  • Meiji Research Site

    Toyota 1849814,
    Japan

    Site Not Available

  • Meiji Research Site

    Ueda 1849429,
    Japan

    Site Not Available

  • Meiji Research Site

    Yokohama 1848354,
    Japan

    Site Not Available

  • Meiji Research Site

    Ōita 1854487,
    Japan

    Site Not Available

  • Meiji Research Site

    Ōtake 1853662,
    Japan

    Site Not Available

  • Meiji Research Site

    Riga 456172,
    Latvia

    Site Not Available

  • Meiji Research Site

    Valmiera 453754,
    Latvia

    Site Not Available

  • Meiji Research Site

    Kaunas 598316,
    Lithuania

    Site Not Available

  • Meiji Research Site

    Vilnius 593116,
    Lithuania

    Site Not Available

  • Meiji Research Site

    Galanta 3060219,
    Slovakia

    Site Not Available

  • Meiji Research Site

    Rimavská Sobota 723736,
    Slovakia

    Site Not Available

  • Meiji Research Site

    Svidník 723417,
    Slovakia

    Site Not Available

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