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一项了解氨曲南-阿维巴坦 (ATM-AVI) 治疗细菌感染医院婴儿和新生儿的研究 (CHERISH) (CHERISH)

2026年10月14日 更新者：Pfizer

一项 2a 期、两部分、开放标签、非随机、多中心、单剂量和多剂量试验，旨在评估氨曲南和阿维巴坦 ± 甲硝唑在新生儿和 9 个月以下婴儿中的药代动力学、安全性和耐受性疑似或确诊的革兰氏阴性病原体感染需要静脉注射抗生素治疗

The purpose of this study is to learn about the safety and effects of ATM-AVI for the possible treatment of infections caused by a type of bacteria called gram-negative bacteria.

The study medicine is a combination of an antibiotic, aztreonam (ATM), and another medicine, avibactam (AVI), which is used to help stop bacteria from being resistant to antibiotics. Antibiotics are medicines that fights bacteria and infections.

The study will include newborns and infants up to 9 months of age who are admitted in the hospital.

The study is conducted in 2 parts: Part A and Part B.

In Part A, all participants will receive a single intravenous (injected directly into a vein) infusion of ATM-AVI. This is to study the safety and effects of a single amount.

In Part B, all participants will receive multiple intravenous infusions of ATM-AVI as treatment for a possible or confirmed infection with gram-negative bacteria.

研究概览

地位

招聘中

条件

干预/治疗

详细说明

This is a 2-part Phase 2a, non-randomized, multicenter, open-label, single and multi-dose study to assess pharmacokinetics (PK), safety, and tolerability of ATM-AVI in hospitalized neonates and infants aged birth, including preterm birth, to <9 months. A total of 48 participants will be enrolled in 4 age cohorts of 12 each, 6 Part A and 6 Part B. Part A will begin enrolling before Part B and no infant may participate in both parts. Cohort 1 will include full term infants age ≥13 weeks to <39 weeks and preterm infants postmenstrual age ≥50 weeks to <75 weeks. Cohort 2 will include full term infants age ≥28 weeks to <13 weeks and preterm infants postmenstrual age ≥40 weeks to <50 weeks and ≥28 days of age. Cohort 3 will include full term infants age birth to <28 days. Cohort 4 will include preterm infants age birth to <28 days or postmenstrual age <40 weeks.

Participants in Part A must be hospitalized and receiving intravenous antibiotic treatment for a suspected or confirmed bacterial infection. Participants will receive a single 3 hour intravenous infusion of ATM-AVI and have 3 ATM-AVI blood level assessments during and up to 5 hour after the infusion. Participants will be observed for 48 hours following the infusion to assess safety and toleration and will have a final follow-up safety assessment which may be conducted by telephone 4-5 weeks following the infusion. The single infusion of ATM-AVI is administered to assess the safety, tolerability, and pharmacokinetics of a single dose of ATM-AVI and is not intended as treatment for the bacterial infection. The total duration of study participation in Part A is expected to be 5 weeks through the end of the final safety follow-up.

Participants in Part B must be hospitalized with suspected or confirmed aerobic gram-negative bacterial infection requiring intravenous antibacterial therapy. Part B participants will receive multiple 3 hour intravenous infusions of ATM-AVI every 6 hour (8 hours for preterm infants) for 3-14 days as treatment for their bacterial infection and to assess ATM-AVI pharmacokinetics, safety, tolerability, and efficacy. Participants with complicated intra-abdominal infection (cIAI) will also receive intravenous metronidazole and all participants will have the option to receive other intravenous antibiotic treatment for gram-positive bacteria, as appropriate. Participants who have a good clinical response after 72 hours of intravenous ATM-AVI treatment may be switched to a different orally administered antibiotic, if clinically appropriate. Part B participants will have a total of 5 ATM-AVI blood level assessments over the first 2 or more days following the start of ATM-AVI infusions and will have their clinical response assessed at the End of Treatment (intravenous and oral, if applicable), and at a Test-of-Cure (TOC) evaluation 7 to 14 days after the last antibiotic treatment (intravenous or oral). A final safety assessment which may be conducted by telephone will occur 4-5 weeks after the last dose of ATM-AVI. The total duration of study participation in Part B is expected to be up to 7 weeks through the end of the final safety follow-up.

Additional safety monitoring will be provided by an independent external Data Monitoring Committee (DMC). Enrollment for the study will begin with Part A, single dose, cohorts 1-3. Part A Cohort 4 (preterm neonates) will commence enrollment after sponsor and DMC review of plasma drug levels and safety for a least 2 participants in Part A Cohort 3 and review of ATM-AVI safety and tolerability for all participants enrolled at that time. Enrollment in the multidose Part B cohorts will be delayed until preliminary information is obtained regarding ATM-AVI multidose safety, tolerability, and drug levels for the participants 9 months to 2 years of age in the separate ongoing ATM-AVI pediatric study C3601008 [NCT05639647].

研究类型

介入性

注册 (估计的)

48

阶段

  • 阶段2

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

学习地点

  • 以色列
    • Central District
      • Petah Tikva、Central District、以色列、49202
        • 招聘中
        • Schneider Children's Medical Center
    • Northern District
      • Haifa、Northern District、以色列、3109601
        • 招聘中
        • Rambam Health Care Campus
  • 保加利亚
      • Burgas、保加利亚、8000
        • 招聘中
        • UMHAT Deva Maria
      • Rousse、保加利亚、7002
        • 招聘中
        • Umhat Kanev
  • 印度
    • Gujarat
      • Surat、Gujarat、印度、395002
        • 招聘中
        • Nirmal Hospital Pvt Ltd.
    • Karnataka
      • Bengaluru、Karnataka、印度、560074
        • 招聘中
        • RajaRajeswari Medical College and Hospital
    • Maharashtra
      • Pune、Maharashtra、印度、411006
        • 招聘中
        • Sahyadri Super Speciality Hospital
    • Uttar Pradesh
      • Lucknow、Uttar Pradesh、印度、226030
        • 招聘中
        • Medanta Hospital Lucknow
    • West Bengal
      • Kolkata、West Bengal、印度、700017
        • 招聘中
        • Institute of Child Health
  • 台湾
      • Taichung、台湾、407
        • 招聘中
        • Taichung Veterans General Hospital
      • Taoyuan、台湾、33305
        • 招聘中
        • Chang Gung Medical Foundation Linkou Chang Gung Memorial Hospital
    • Hsinchu
      • Hsinchu、Hsinchu、台湾、300046
        • 招聘中
        • Hsinchu Municipal Mackay Children's Hospital
    • Hualien
      • Hualien City、Hualien、台湾、970
        • 招聘中
        • Hualien Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
  • 希腊
    • Kentrikí Makedonía
      • Thessaloniki、Kentrikí Makedonía、希腊、546 42
        • 尚未招聘
        • Ippokrateio General Hospital of Thessaloniki
  • 意大利
    • Florence
      • Florence、Florence、意大利、50139
        • 招聘中
        • Azienda Ospedaliera Universitaria Meyer IRCCS
  • 美国
    • California
      • Orange、California、美国、92868
        • 招聘中
        • Children's Hospital of Orange County
      • Orange、California、美国、92868
        • 招聘中
        • Children's Hospital of Orange County Southwest Tower
    • Colorado
      • Aurora、Colorado、美国、80045
        • 招聘中
        • Children's Hospital Colorado
    • Indiana
      • Indianapolis、Indiana、美国、46202
        • 招聘中
        • Riley Hospital for Children at Indiana University Health
    • Kentucky
      • Louisville、Kentucky、美国、40202
        • 招聘中
        • Norton Children's Hospital
      • Louisville、Kentucky、美国、40202
        • 招聘中
        • Novak Center for Children's Health
      • Louisville、Kentucky、美国、40202
        • 招聘中
        • University of Louisville, Norton Children's Research Institute
    • Massachusetts
      • Boston、Massachusetts、美国、02111
        • 招聘中
        • Tufts Medical Center
    • North Carolina
      • Durham、North Carolina、美国、27710
        • 招聘中
        • Duke University - Main Hospital and Clinics
    • Texas
      • Houston、Texas、美国、77030
        • 招聘中
        • The University of Texas Health Science Center at Houston
      • Houston、Texas、美国、77030
        • 招聘中
        • Memorial Hermann Hospital - Texas Medical Center
  • 西班牙
      • Madrid、西班牙、28041
        • 尚未招聘
        • Hospital Universitario 12 de Octubre
    • Madrid, Comunidad de
      • Madrid、Madrid, Comunidad de、西班牙、28046
        • 招聘中
        • Hospital Universitario La Paz
  • 阿根廷
    • Buenos Aires
      • Ciudad Autónoma de Buenos Aires、Buenos Aires、阿根廷、1039
        • 招聘中
        • Sanatorio Sagrado Corazón
      • Mar del Plata、Buenos Aires、阿根廷、7600
        • 招聘中
        • Clinica Del Niño Y La Madre
    • Córdoba Province
      • Córdoba、Córdoba Province、阿根廷、X5000IIH
        • 招聘中
        • Clinica Privada del Sol S.A
    • Tucumán Province
      • San Miguel de Tucumán、Tucumán Province、阿根廷、4000
        • 招聘中
        • Hospital del Niño Jesús

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

不超过 9个月 (孩子)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria

Participants must meet the following key inclusion criteria to be eligible for enrollment into the study:

  1. Hospitalized with age from birth <9 months, including preterm birth
  2. Part A: Receiving IV antibiotics for treatment of suspected or confirmed bacterial infection, including but not limited to cIAI, cUTI, HAP/VAP, BSI, or sepsis.
  3. Part B: Suspected or confirmed gram-negative bacterial infection requiring IV antibiotics, including but not limited to cIAI, cUTI, HAP/VAP, BSI, or sepsis.

Participants with any of the following characteristics/conditions will be excluded:

  1. Received any other investigational medicinal product within the longer of 30 days or 5 half-lives before enrollment.
  2. Any medical or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.
  3. Severe renal impairment or known significant renal disease, as evidenced by elevated serum creatinine at screening, or urinary output <0.5 mL/kg/h for 6 consecutive hours or requirement for dialysis.
  4. Part B Only: Received >24 hours of systemic antibiotic treatment for gram-negative organisms at time of enrollment, unless documented treatment failure or lack of improvement in at least one objective sign or symptom of infection after ≥48 hours of antibiotics.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：基础科学
  • 分配：非随机化
  • 介入模型：单组作业
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
实验性的：Part A, Cohorts 1-4

Single dose pharmacokinetics.
药品：Part A: ATM-AVI Single Dose, Cohorts 1-4

Single intravenous infusion of aztreonam-avibactam over 3 hours to assess pharmacokinetics, safety, and toleration.
实验性的：Part B, Cohorts 1-4

Multi-dose pharmacokinetics and treatment
药品：Part B: Multiple-dose ATM-AVI, Cohorts 1-4

Multiple intravenous infusions of aztreonam-avibactam over 3 hours, repeated every 6-8 hours up to 14 days to assess pharmacokinetics, safety, toleration, and efficacy.

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Maximum Predicted Plasma Concentration (Cmax) of ATM and AVI
大体时间：Up to Day 15

Cmax is the maximum plasma concentration of ATM and AVI as population pharmacokinetic (popPK) analysis predicts.
Up to Day 15
Area under the Concentration-Time Curve (AUC) of ATM-AVI
大体时间：Up to Day 15

AUC is a measure of the plasma concentration of ATM and AVI overtime as popPK analysis predicts.
Up to Day 15
Plasma Elimination Half-Life (t1/2)
大体时间：Up to Day 15

Half-life is the time measured for the plasma concentration of ATM and AVI to decrease by one half as popPK analysis predicts.
Up to Day 15
Apparent Clearance (CL)
大体时间：Up to Day 15

ATM and AVI clearance is a quantitative measure of the rate at which ATM and AVI are removed from the blood (rate at which ATM and AVI are metabolized or eliminated by normal biological processes). Clearance obtained after intravenous infusion dose (apparent clearance) is influenced by the fraction of the dose absorbed.
Up to Day 15
Plasma concentrations of ATM and AVI by nominal sampling time
大体时间：Up to Day 15

Plasma concentrations of ATM and AVI on Day 1 and at steady state (Day 2 or later) will be summarized by the nominal sampling time using descriptive statistics (eg number, mean, standard deviation).
Up to Day 15
Proportion of Participants reporting Adverse Events (AE)
大体时间：Baseline up to Day 50

Proportion of participant AE reports of vital signs, physical examinations, and clinical laboratory tests overall and by age cohort. For each AE the last assessment made prior to the first dose of study drug will be defined as the baseline.
Baseline up to Day 50
Proportion of Participants reporting Serious Adverse Events (SAE)
大体时间：Baseline up to Day 50

Proportion of participant SAE reports of vital signs, physical examinations, and clinical laboratory tests overall and by age cohort. For each SAE the last assessment made prior to the first dose of study drug will be defined as the baseline.
Baseline up to Day 50
Proportion of Participants reporting AEs leading to discontinuation of study drug
大体时间：Baseline up to Day 50

Proportion of Participants reporting AEs leading to discontinuation of study drug from baseline. For each discontinuation the last assessment made prior to the first dose of study drug will be defined as the baseline.
Baseline up to Day 50
Proportion of Participants reporting AEs resulting in death
大体时间：Baseline up to Day 50

Proportion of Participants reporting AE resulting in death from baseline. For each death the last assessment made prior to the first dose of study drug will be defined as the baseline.
Baseline up to Day 50
Proportion of Participants reporting liver injury and acute kidney injury
大体时间：Baseline up to Day 50

Proportion of Participants reporting liver injury and acute kidney injury from baseline. For each report of liver and acute kidney injury the last assessment made prior to the first dose of study drug will be defined as the baseline.
Baseline up to Day 50

次要结果测量

结果测量
措施说明
大体时间
Part B: Proportion of participants with each clinical outcome and with a favorable clinical outcome at end of IV study treatment (EOIV)
大体时间：Up to 15 days after start of IV study treatment

Clinical Cure is defined baseline signs and symptoms improved such that no further antimicrobial treatment is required for an aerobic gram-negative baseline infection. Participants who receive treatment for gram-positive organisms or adjunctive therapy for Pseudomonas aeruginosa, as allowed per protocol, can still have a response of cure. Clinical improvement is defined as baseline signs and symptoms sufficiently improved to allow switching to an oral antibiotic treatment. A favorable outcome is clinical cure or clinical improvement. Failure is defined as a requirement for further antibiotic treatment, including following premature discontinuation due to an adverse event, or death after receiving at least 48 hours of treatment. Indeterminant is defined as data not available for evaluation of efficacy for any reason.
Up to 15 days after start of IV study treatment
Part B: Proportion of participants with each clinical outcome and with a favorable clinical outcome at end of treatment (EOT)
大体时间：Within 48 hours after last dose of oral switch treatment

EOT is only applicable for participants switched to an oral antibiotic treatment. Possible outcomes are cure, failure, or indeterminant.
Within 48 hours after last dose of oral switch treatment
Part B: Proportion of participants with each clinical outcome and with a favorable clinical outcome at test of cure (TOC)
大体时间：7-14 days after the last study treatment

Possible outcomes are cure, failure, or indeterminant.
7-14 days after the last study treatment
Part B: Proportion of participants with a favorable microbiological response at TOC
大体时间：7-14 days after the last study treatment

A favorable response is eradication or presumed eradication. Eradication is absence of the causative pathogen from an appropriately obtained specimen at the site of infection. Presumed eradication is when a repeat culture was not performed and the clinical response is cure.
7-14 days after the last study treatment
Part B: Counts and proportions of pathogens with each per-pathogen microbiological response at EOIV/EOT
大体时间：Up to 15 days after start of IV study treatment

Possible outcomes are eradication, presumed eradication, persistence, presumed persistence or indeterminate. Presumed eradication/persistence based on repeat culture not performed and clinical outcome of cure/failure. Persistence is the causative pathogen is still present from an appropriately obtained specimen at the site of the infection. Indeterminant includes participant lost to follow-up or death after receiving less than 48 hours of study treatment.
Up to 15 days after start of IV study treatment
Part B: Counts and proportions of pathogens with each per-pathogen microbiological response at TOC
大体时间：7-14 days after the last study treatment

Possible outcomes are eradication, presumed eradication, persistence, presumed persistence or indeterminate.
7-14 days after the last study treatment
Part B: Counts and proportions of participants with emergent infections (new infections or superinfections) during the study
大体时间：Through study completion, up to Day 50

Superinfection is defined as emergence of a new pathogen associated with worsening signs and symptoms of infection and a requirement for additional antibiotics during the period up to and including EOIV/EOT. New infection is defined as emergence of a new pathogen associated with worsening signs and symptoms of infection and a requirement for additional antibiotics during the period after EOIV/EOT.
Through study completion, up to Day 50

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Pfizer

合作者

AbbVie

调查人员

  • 研究主任：Pfizer CT.gov Call Center、Pfizer

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

有用的网址

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2024年9月25日

初级完成 (估计的)

2027年4月25日

研究完成 (估计的)

2027年4月25日

研究注册日期

首次提交

2024年5月28日

首先提交符合 QC 标准的

2024年6月14日

首次发布 (实际的)

2024年6月17日

研究记录更新

最后更新发布 (实际的)

2026年10月15日

上次提交的符合 QC 标准的更新

2026年10月14日

最后验证

2026年10月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • C3601010
  • 2023-507757-15-01 (注册表标识符：CTIS (EU))
  • 2023 (美国 NIH 拨款/合同)

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

是的

IPD 计划说明

Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

药物和器械信息、研究文件

研究美国 FDA 监管的药品

是的

研究美国 FDA 监管的设备产品

不

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