MedDataX Logo

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

NCT ID: NCT05887908

Last Updated: 2025-12-24

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

614 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-05-23

Study Completion Date

2024-11-26

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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).

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Complicated Urinary Tract Infection Acute Pyelonephritis cUTI AP

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

OP0595 nacubactam Integral

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

co-administration of cefepime and nacubactam

co-administration of 2 g cefepime and 1 g nacubactam q8h (60 min. infusion)

Group Type EXPERIMENTAL

co-administration of cefepime and nacubactam

Intervention Type DRUG

2 g cefepime and 1 g nacubactam

co-administration of aztreonam and nacubactam

co-administration of 2 g aztreonam and 1 g nacubactam q8h (60 min. infusion)

Group Type EXPERIMENTAL

co-administration of aztreonam and nacubactam

Intervention Type DRUG

2 g aztreonama and 1 g nacubactam

imipenem/cilastatin

combination of 1 g imipenem/1 g cilastatin q8h (60 min. infusion)

Group Type ACTIVE_COMPARATOR

imipenem/cilastatin

Intervention Type DRUG

1 g imipenem/1 g cilastatin

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

co-administration of cefepime and nacubactam

2 g cefepime and 1 g nacubactam

Intervention Type DRUG

co-administration of aztreonam and nacubactam

2 g aztreonama and 1 g nacubactam

Intervention Type DRUG

imipenem/cilastatin

1 g imipenem/1 g cilastatin

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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;
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Meiji Seika Pharma Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Meiji Research Site

Pleven, , Bulgaria

Site Status

Meiji Research Site

Rousse, , Bulgaria

Site Status

Meiji Research Site

Silistra, , Bulgaria

Site Status

Meiji Research Site

Sofia, , Bulgaria

Site Status

Meiji Research Site

Beijing, , China

Site Status

Meiji Research Site

Changchun, , China

Site Status

Meiji Research Site

Chongqing, , China

Site Status

Meiji Research Site

Fuyang, , China

Site Status

Meiji Research Site

Ganzhou, , China

Site Status

Meiji Research Site

Huaian, , China

Site Status

Meiji Research Site

Huzhou, , China

Site Status

Meiji Research Site

Nanchang, , China

Site Status

Meiji Research Site

Nanning, , China

Site Status

Meiji Research Site

Quanzhou, , China

Site Status

Meiji Research Site

Shanghai, , China

Site Status

Meiji Research Site

Shantou, , China

Site Status

Meiji Research Site

Shijiazhuang, , China

Site Status

Meiji Research Site

Taian, , China

Site Status

Meiji Research Site

Tianjin, , China

Site Status

Meiji Research Site

Xuancheng, , China

Site Status

Meiji Research Site

Yunnan, , China

Site Status

Meiji Research Site

Zhejiang, , China

Site Status

Meiji Research Site

Zhengzhou, , China

Site Status

Meiji Research Site

Hradec Králové, , Czechia

Site Status

Meiji Research Site

Liberec, , Czechia

Site Status

Meiji Research Site

Prague, , Czechia

Site Status

Meiji Research Site

Ústí nad Labem, , Czechia

Site Status

Meiji Research Site

Meegomäe, Võrumaa, Estonia

Site Status

Meiji Research Site

Kohtla-Järve, , Estonia

Site Status

Meiji Research Site

Tallinn, , Estonia

Site Status

Meiji Research Site

Tartu, , Estonia

Site Status

Meiji Research Site

Kutaisi, , Georgia

Site Status

Meiji Research Site

Rustavi, , Georgia

Site Status

Meiji Research Site

Tbilisi, , Georgia

Site Status

Meiji Research Site

Fukuyama, , Japan

Site Status

Meiji Research Site

Gifu, , Japan

Site Status

Meiji Research Site

Ibaraki-Town, Higashiibaraki-County, , Japan

Site Status

Meiji Research Site

Iwakuni, , Japan

Site Status

Meiji Research Site

Kanazawa, , Japan

Site Status

Meiji Research Site

Kawachi-Nagano, , Japan

Site Status

Meiji Research Site

Kofu, , Japan

Site Status

Meiji Research Site

Kumamoto, , Japan

Site Status

Meiji Research Site

Matsumoto, , Japan

Site Status

Meiji Research Site

Mizumaki-Town, Onga-County, , Japan

Site Status

Meiji Research Site

Nagasaki, , Japan

Site Status

Meiji Research Site

Nankoku, , Japan

Site Status

Meiji Research Site

Ōita, , Japan

Site Status

Meiji Research Site

Ōtake, , Japan

Site Status

Meiji Research Site

Sagamihara, , Japan

Site Status

Meiji Research Site

Sapporo, , Japan

Site Status

Meiji Research Site

Shinjuku-ku, , Japan

Site Status

Meiji Research Site

Toyota, , Japan

Site Status

Meiji Research Site

Ueda, , Japan

Site Status

Meiji Research Site

Yokohama, , Japan

Site Status

Meiji Research Site

Riga, , Latvia

Site Status

Meiji Research Site

Valmiera, , Latvia

Site Status

Meiji Research Site

Kaunas, , Lithuania

Site Status

Meiji Research Site

Vilnius, , Lithuania

Site Status

Meiji Research Site

Galanta, , Slovakia

Site Status

Meiji Research Site

Rimavská Sobota, , Slovakia

Site Status

Meiji Research Site

Svidník, , Slovakia

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Bulgaria China Czechia Estonia Georgia Japan Latvia Lithuania Slovakia

Provided Documents

Download supplemental materials such as informed consent forms, study protocols, or participant manuals.

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

OP0595-5

Identifier Type: -

Identifier Source: org_study_id