A Phase 3, Multi-Center, Randomized, Single-Blind Study to assess the Efficacy and Safety of Cefepime/Nacubactam and Aztreonam/Nacubactam Versus Best Available Therapy in Adults With Complicated Urinary Tract Infection, Acute Uncomplicated Pyelonephritis, Hospital-Acquired Bacterial Pneumonia, Ventilator-Associated Bacterial Pneumonia, and Complicated Intra-Abdominal Infection due to Carbapenem Resistant Enterobacterales (Integral-2)

Meiji Seika Pharma Co.,Ltd.0 个研究点目标入组 150 人开始时间: 2023年5月23日最近更新: 2025年5月7日

适应症

试验速览

阶段: 不适用
状态: 招募中
发起方: Meiji Seika Pharma Co.,Ltd.
入组人数: 150
主要终点: proportion of patients with overall treatment success at TOC across all infection types

研究概览研究设计入排标准结局指标研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型: Interventional
分配方式: Randomized Controlled Trial
干预模型: Parallel Assignment
主要目的: Treatment Purpose
盲法: Single Blind

入排标准

年龄范围: 18age old over 至 No limit（—）
性别: All

入选标准

•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;
•Weight at most140 kg;
•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 based on evidence from CRE culture and susceptibility testing or other phenotypic or molecular testing within 72 hours (or 96 hours for cIAI) prior to the first dose, alone or as a single isolate of a polymicrobial infection; 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;
•ii. Has a known CRE infection based on evidence from CRE culture and susceptibility testing or other phenotypic or molecular testing within 72 hours (or 96 hours for cIAI) prior to the first dose, alone or as a single isolate of a polymicrobial infection; 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;
•b. For suspected CRE infection, meets the following (i or ii):
•i. Has a suspected CRE infection based on evidence from CRE culture and susceptibility testing or other phenotypic or molecular testing, alone or as a single isolate of a polymicrobial infection, from any source within 90 days prior to Day 1; 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;
•ii. Has a suspected CRE infection based on evidence from CRE culture and susceptibility testing or other phenotypic or molecular testing, alone or as a single isolate of a polymicrobial infection, from any source within 90 days prior to Day 1; 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;
•Note: CRE is defined as Enterobacterales by susceptibility data of minimum inhibitory concentration (MIC) at least 2 micro g/mL to imipenem or meropenem OR imipenem or meropenem disk diffusion (zone diameter less than 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.

排除标准

•Has a history of serious allergy, hypersensitivity (eg, anaphylaxis), or any serious allergic reaction to carbapenems, cephems, penicillins, other beta-lactam antibiotics, or any beta-lactamase inhibitors (eg, tazobactam, sulbactam, or clavulanic acid);
•Has known or suspected single or concurrent infection with Acinetobacter spp., metallo-beta-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 best available therapy (BAT) if anaerobic coverage is deemed necessary.
•Has only a Gram-positive organism pathogen isolated from study-qualifying culture;

结局指标

主要结局

proportion of patients with overall treatment success at TOC across all infection types

时间窗: TOC

The primary efficacy endpoint is the proportion of patients with overall treatment success at TOC across all infection types (ie, cUTI, AP, HABP, VABP, and cIAI), which is a composite endpoint derived from the efficacy outcomes of each infection type. This is the proportion of patients in the Microbiological CRE Modified Intent to-Treat (mCRE-MITT) Population with a treatment outcome of success.

incidence, severity, causality, and seriousness of TEAEs

The safety parameters include the incidence, severity, causality, and seriousness of TEAEs.

changes from baseline in safety laboratory test results, 12-lead ECGs, vital signs, and physical examinations

The safety parameters include the evaluation of changes from baseline in safety laboratory test results, 12-lead ECGs, vital signs, and physical examinations.

次要结局

未报告次要终点

研究者

发起方

Meiji Seika Pharma Co.,Ltd.

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