2024-515180-56-00招募中3 期
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 (OP0595-6)
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 96
- 试验地点
- 16
- 主要终点
- 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.
研究概览
简要总结
- To assess the efficacy of cefepime/nacubactam and aztreonam/nacubactam administered by intravenous (IV) infusion using the composite endpoint of overall treatment success across all infection types (ie, cUTI, AP, HABP, VABP, and cIAI) due to carbapenemresistant Enterobacterales (CRE); and
- To assess the safety of cefepime/nacubactam and aztreonam/nacubactam administered by IV infusion.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 是
入选标准
- •Male or female patients ≥ 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 ≤ 140 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, 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; OR 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: Complete list of inclusion criteria is in the protocol.
排除标准
- •Has a history of serious allergy, hypersensitivity (eg, anaphylaxis), or any serious allergic reaction to carbapenems, cephems, penicillins, other B-lactam antibiotics, or any B-lactamase inhibitors (eg, tazobactam, sulbactam, or clavulanic acid) or to any of the excipients
- •Has known or suspected single or concurrent infection with Acinetobacter spp., metallo-βlactamase (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 coinfected (or suspected to be 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 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. When these drugs are used as a concomitant drug, the Investigator should confirm the patient does not have hypersensitivity to that drug or excipient before use. Note: Patients in whom a carbapenem-resistant Pseudomonas aeruginosa is identified may be continued on the study drug only if the patient was (1) enrolled in this study as a suspected CRE, (2) the causative organism is found to be P. aeruginosa after randomization, (3) does not meet exclusion or discontinuation criteria, and (4) the patient is clinically improving on study drug.
- •Has only a Gram-positive organism pathogen isolated from studyqualifying culture
- •Note: Complete list of exclusion criteria is in the protocol.
结局指标
主要结局
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.
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.
次要结局
- Secondary efficacy endpoints across all infection types, for individual infection type and across all infection types, for cUTI/AP only, for HABP/VABP only, or cIAI only, for secondary bacteremia only are included in study protocol
研究者
Regulatory Submissions
Scientific
Meiji Seika Pharma Co. Ltd.
研究点 (16)
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