A Prospective, Multicenter Registry to Evaluate Metagenomic Sequencing Across the Infectious Disease Risk and Care Continuum
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- Karius, Inc.
- 入组人数
- 10,000
- 主要终点
- Time to Antimicrobial Modification Following Karius Spectrum Result Availability
研究概览
简要总结
The AXIS Network is a prospective, multicenter observational registry designed to generate real-world evidence on the use of metagenomic sequencing in clinical practice across a broad range of patient populations, infectious disease syndromes, and clinical care settings.
Participants receiving routine clinical care at participating institutions may be enrolled into cohort-specific registries that evaluate how metagenomic sequencing is used for diagnostic evaluation, surveillance of high-risk populations, or longitudinal monitoring of treatment response. The study does not assign participants to any intervention, alter standard clinical care, or require study-mandated testing or treatment. Instead, it collects clinical information generated during routine care, including diagnostic testing, antimicrobial use, clinical management decisions, healthcare utilization, and clinical outcomes.
The primary objective of AXIS is to evaluate how metagenomic sequencing informs clinical decision-making and is associated with downstream management and clinical outcomes. Secondary objectives include characterization of test utilization patterns, diagnostic integration, antimicrobial management decisions, healthcare utilization, and longitudinal monitoring strategies. Data collected through AXIS may also support development of predictive models and clinical decision-support tools.
详细描述
The AXIS Network is a prospective, multicenter observational registry designed to evaluate the real-world use of metagenomic sequencing across the infectious disease care continuum. The registry serves as a scalable platform for generating real-world evidence regarding how sequencing-based infectious disease diagnostics are utilized in clinical practice and how diagnostic information influences patient management and outcomes.
AXIS is structured as a master protocol with modular cohort appendices that allow evaluation of metagenomic sequencing across diverse patient populations, clinical syndromes, care settings, specimen types, and clinical use contexts. Cohorts may include participants undergoing metagenomic sequencing as part of routine clinical care, participants receiving usual-care diagnostic testing without sequencing, or both, depending on the objectives of the specific cohort.
The registry is designed to evaluate metagenomic sequencing in several clinical contexts, including:
Diagnostic evaluation of patients with suspected infection Surveillance of populations at increased risk for infection Longitudinal monitoring of treatment response or recurrent infection
AXIS places particular emphasis on immunocompromised populations, including patients with hematologic malignancies, solid organ transplant recipients, hematopoietic stem cell transplant recipients, individuals receiving immunosuppressive therapies, and other high-risk populations. Both adult and pediatric participants may be enrolled, depending on cohort-specific eligibility criteria.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participant receives care at a participating AXIS site.
- •Participant meets eligibility criteria for at least one active AXIS cohort as defined in the applicable cohort appendix.
- •Participant or legally authorized representative is able to provide informed consent, unless waived by the reviewing IRB.
排除标准
- •Any condition that, in the opinion of the investigator, would make participation inappropriate or prevent completion of required study procedures.
- •Additional cohort-specific exclusion criteria may apply and are defined within the applicable cohort appendix.
研究组 & 干预措施
Hospitalized Immunocompromised Adults With Suspected Lower Respiratory Infection
Hospitalized immunocompromised adults with clinical evidence of lower respiratory infection who undergo Karius Spectrum plasma microbial cell-free DNA metagenomic sequencing as part of routine clinical care. Participants are enrolled in a prospective observational registry and are not assigned to any study-directed intervention. Clinical data are collected through routine care and electronic health record review to evaluate associations between metagenomic sequencing results, antimicrobial management decisions, diagnostic testing utilization, healthcare utilization, and clinical outcomes. Participants are followed through hospital discharge and for up to 90 days following discharge, not to exceed 12 months total follow-up.
结局指标
主要结局
Time to Antimicrobial Modification Following Karius Spectrum Result Availability
时间窗: From Karius Spectrum result availability through hospital discharge and up to 90 days following discharge (not to exceed 12 months).
Time from Karius Spectrum result availability to first antimicrobial modification, including initiation, escalation, de-escalation, discontinuation, change in route of administration, or change in duration of therapy.
次要结局
- Participants With Antimicrobial Modification(From enrollment through 90 days following discharge from the index hospitalization, up to 12 months)
- Number of Infection-Directed Microbiological Diagnostic Tests(From Time Zero through discharge from the index hospitalization, up to 12 months)
- Invasive Diagnostic Procedures Ordered Following Karius Spectrum Result Availability(From Karius Spectrum result availability through discharge from the index hospitalization, up to 12 months)
- Hospital Length of Stay From Admission(During the index hospitalization, from admission through discharge, up to 12 months)
- Incidence of Intensive Care Unit Transfer(During the index hospitalization, from admission through discharge, up to 12 months)
- Incidence of Mechanical Ventilation(During the index hospitalization, from admission through discharge, up to 12 months)
- In-Hospital Mortality(During the index hospitalization, from admission through discharge, up to 12 months)
- 30-Day Mortality(Through 30 days following hospital discharge.)
- 30-Day Readmission(Through 30 days following hospital discharge.)
- Clostridioides difficile Infection(Enrollment through 30 days following hospital discharge.)
- Immunosuppressive Therapy Modifications(Baseline through 30 days following hospital discharge.)
- Species-Level Pathogen Identification by Karius Spectrum Compared With Usual Care(From Time Zero through discharge from the index hospitalization, up to 12 months)
- Antimicrobial Days(From enrollment through 90 days following discharge from the index hospitalization, up to 12 months)
- Number of Diagnostic Imaging Studies(From Time Zero through discharge from the index hospitalization, up to 12 months)
- Number of Invasive Diagnostic Procedures(From Time Zero through discharge from the index hospitalization, up to 12 months)
- Invasive Diagnostic Procedures Cancelled Following Karius Spectrum Result Availability(From Karius Spectrum result availability through discharge from the index hospitalization, up to 12 months)
- Hospital Length of Stay From Time Zero(From Time Zero through discharge from the index hospitalization, up to 12 months)
- Timing of Intensive Care Unit Transfer Relative to Time Zero(During the index hospitalization, from admission through discharge, up to 12 months)
- Timing of Mechanical Ventilation Relative to Time Zero(During the index hospitalization, from admission through discharge, up to 12 months)
- Ventilator Days(During the index hospitalization, from initiation of mechanical ventilation through discontinuation or discharge, up to 12 months)