Metagenomic Sequencing Across the Infectious Disease Risk and Care Continuum (AXIS)
A Prospective, Multicenter Registry to Evaluate Metagenomic Sequencing Across the Infectious Disease Risk and Care Continuum
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.
Descripción general del estudio
Estado
Descripción detallada
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.
No study-mandated interventions, treatments, or diagnostic procedures are performed. All diagnostic testing and clinical management decisions are made by treating clinicians according to routine clinical practice. Data are collected through a combination of standardized case report forms and structured extraction of electronic health record data.
Data collected may include:
Demographic and baseline clinical characteristics Diagnostic testing and timing of results Antimicrobial administration and management decisions Procedures and healthcare utilization Clinical outcomes, including mortality and readmissions Longitudinal follow-up information, where applicable
The primary objective of AXIS is to evaluate how metagenomic sequencing informs clinical decision-making and its association with downstream management decisions and clinical outcomes across defined cohorts.
Secondary objectives include:
Characterizing real-world utilization patterns of metagenomic sequencing Describing integration of sequencing results into diagnostic evaluation Evaluating infection-related clinical management decisions associated with sequencing results Assessing longitudinal monitoring and surveillance applications Evaluating healthcare utilization outcomes
Exploratory objectives include assessment of patient-centered outcomes, development of predictive models and clinical decision-support approaches, and establishment of an interactome biobank utilizing residual clinical specimens where permitted.
Approximately 50 sites in the United States are expected to participate. The registry is designed to enroll up to approximately 10,000 participants over a planned study duration of approximately seven years. Data generated through AXIS are intended to improve understanding of how metagenomic sequencing is used in routine clinical practice and to inform future research, clinical care strategies, and diagnostic innovation.
Tipo de estudio
Inscripción (Estimado)
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Kat Kwiatkowsi
- Número de teléfono: 910-232-6396
- Correo electrónico: kat.kwiatkowski@kariusdx.com
Copia de seguridad de contactos de estudio
- Nombre: Mona Mughar
- Número de teléfono: 8653082690
- Correo electrónico: mona.mughar@kariusdx.com
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Método de muestreo
Población de estudio
Participants receiving routine clinical care at participating institutions who meet eligibility criteria for one or more active AXIS cohorts. Cohorts may evaluate metagenomic sequencing for diagnostic evaluation, surveillance, or longitudinal monitoring across a range of infectious disease syndromes, patient populations, and healthcare settings.
This approach prevents you from having to amend the NCT record every time AXIS expands beyond hospitalized immunocompromised patients with lower respiratory infections. It also aligns with how platform registries and master protocols are typically registered.
Descripción
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
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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.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Time to Antimicrobial Modification Following Karius Spectrum Result Availability
Periodo de tiempo: From Karius Spectrum result availability through hospital discharge and up to 90 days following discharge (not to exceed 12 months).
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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.
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From Karius Spectrum result availability through hospital discharge and up to 90 days following discharge (not to exceed 12 months).
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Participants With Antimicrobial Modification
Periodo de tiempo: From enrollment through 90 days following discharge from the index hospitalization, up to 12 months
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Proportion of participants with at least one antimicrobial modification, including initiation, escalation, de-escalation, discontinuation, change in route of administration, or change in duration of therapy.
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From enrollment through 90 days following discharge from the index hospitalization, up to 12 months
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Number of Infection-Directed Microbiological Diagnostic Tests
Periodo de tiempo: From Time Zero through discharge from the index hospitalization, up to 12 months
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Number of infection-directed microbiological diagnostic tests performed during the index encounter, summarized by test type.
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From Time Zero through discharge from the index hospitalization, up to 12 months
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Invasive Diagnostic Procedures Ordered Following Karius Spectrum Result Availability
Periodo de tiempo: From Karius Spectrum result availability through discharge from the index hospitalization, up to 12 months
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Number of invasive diagnostic procedures ordered following Karius Spectrum result availability, summarized by procedure type.
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From Karius Spectrum result availability through discharge from the index hospitalization, up to 12 months
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Hospital Length of Stay From Admission
Periodo de tiempo: During the index hospitalization, from admission through discharge, up to 12 months
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Hospital length of stay calculated as the number of days from admission to discharge from the index hospitalization.
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During the index hospitalization, from admission through discharge, up to 12 months
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Incidence of Intensive Care Unit Transfer
Periodo de tiempo: During the index hospitalization, from admission through discharge, up to 12 months
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Proportion of participants who experience transfer to an intensive care unit during the index hospitalization.
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During the index hospitalization, from admission through discharge, up to 12 months
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Incidence of Mechanical Ventilation
Periodo de tiempo: During the index hospitalization, from admission through discharge, up to 12 months
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Proportion of participants requiring mechanical ventilation during the index hospitalization.
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During the index hospitalization, from admission through discharge, up to 12 months
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In-Hospital Mortality
Periodo de tiempo: During the index hospitalization, from admission through discharge, up to 12 months
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Incidence of mortality during the index hospitalization.
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During the index hospitalization, from admission through discharge, up to 12 months
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30-Day Mortality
Periodo de tiempo: Through 30 days following hospital discharge.
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Incidence of mortality within 30 days following hospital discharge.
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Through 30 days following hospital discharge.
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30-Day Readmission
Periodo de tiempo: Through 30 days following hospital discharge.
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Incidence of hospital readmission within 30 days following hospital discharge.
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Through 30 days following hospital discharge.
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Clostridioides difficile Infection
Periodo de tiempo: Enrollment through 30 days following hospital discharge.
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Incidence of Clostridioides difficile infection during the study period.
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Enrollment through 30 days following hospital discharge.
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Immunosuppressive Therapy Modifications
Periodo de tiempo: Baseline through 30 days following hospital discharge.
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Proportion of participants with any immunosuppressive therapy modification within a specified timeframe following usual-care or Karius Spectrum result availability.
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Baseline through 30 days following hospital discharge.
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Species-Level Pathogen Identification by Karius Spectrum Compared With Usual Care
Periodo de tiempo: From Time Zero through discharge from the index hospitalization, up to 12 months
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Proportion of participants with a Karius Spectrum identification at the species level for which usual-care diagnostic testing has no corresponding detection or only a genus-level detection.
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From Time Zero through discharge from the index hospitalization, up to 12 months
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Antimicrobial Days
Periodo de tiempo: From enrollment through 90 days following discharge from the index hospitalization, up to 12 months
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Number of days of antimicrobial therapy, summarized by antimicrobial spectrum, antimicrobial type, and route of administration.
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From enrollment through 90 days following discharge from the index hospitalization, up to 12 months
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Number of Diagnostic Imaging Studies
Periodo de tiempo: From Time Zero through discharge from the index hospitalization, up to 12 months
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Number of diagnostic imaging studies performed during the index encounter, summarized by imaging type.
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From Time Zero through discharge from the index hospitalization, up to 12 months
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Number of Invasive Diagnostic Procedures
Periodo de tiempo: From Time Zero through discharge from the index hospitalization, up to 12 months
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Number of invasive diagnostic procedures performed during the index encounter, including procedures such as needle aspiration and bronchoscopy.
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From Time Zero through discharge from the index hospitalization, up to 12 months
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Invasive Diagnostic Procedures Cancelled Following Karius Spectrum Result Availability
Periodo de tiempo: From Karius Spectrum result availability through discharge from the index hospitalization, up to 12 months
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Number of invasive diagnostic procedures cancelled following Karius Spectrum result availability, summarized by procedure type.
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From Karius Spectrum result availability through discharge from the index hospitalization, up to 12 months
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Hospital Length of Stay From Time Zero
Periodo de tiempo: From Time Zero through discharge from the index hospitalization, up to 12 months
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Hospital length of stay calculated as the number of days from Time Zero to discharge from the index hospitalization.
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From Time Zero through discharge from the index hospitalization, up to 12 months
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Timing of Intensive Care Unit Transfer Relative to Time Zero
Periodo de tiempo: During the index hospitalization, from admission through discharge, up to 12 months
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Timing of intensive care unit transfer relative to Time Zero among participants who experience an ICU transfer, characterized according to whether transfer occurs before or after Time Zero.
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During the index hospitalization, from admission through discharge, up to 12 months
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Timing of Mechanical Ventilation Relative to Time Zero
Periodo de tiempo: During the index hospitalization, from admission through discharge, up to 12 months
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Timing of initiation of mechanical ventilation relative to Time Zero among participants requiring mechanical ventilation, characterized according to whether initiation occurs before or after Time Zero.
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During the index hospitalization, from admission through discharge, up to 12 months
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Ventilator Days
Periodo de tiempo: During the index hospitalization, from initiation of mechanical ventilation through discontinuation or discharge, up to 12 months
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Number of ventilator-days among participants requiring mechanical ventilation.
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During the index hospitalization, from initiation of mechanical ventilation through discontinuation or discharge, up to 12 months
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Kat Kwiatkowski, PhD, Karius, Inc.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
- Huésped inmunocomprometido
- Malignidad hematológica
- Registro observacional
- Trasplante de células madre
- Utilización de atención médica
- Trasplante de órganos sólidos
- Infección oportunista
- Mayordomía de diagnóstico
- Toma de decisiones clínicas
- Evidencia del mundo real
- Espectro de Karius
- Metagenomic Sequencing
- Microbial Cell-Free DNA
- Infectious Disease Diagnostics
- Precision Diagnostics
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- KAR-0040
Plan de datos de participantes individuales (IPD)
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Información sobre medicamentos y dispositivos, documentos del estudio
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