An observational study in Infectious Diseases, Immunocompromised Host and Opportunistic Infections, sponsored by Karius, Inc.. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-17.
Sponsored by Karius, Inc. · Observational
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.
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.
626 studies on the registry are indexed under Communicable Diseases; 128 are open to participants now.
This study's planned enrollment of 10,000 is above the median of 200 across 228 observational studies indexed under Communicable Diseases.
Browse Communicable Diseases studies →Karius, Inc. is the lead sponsor of 10 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Time to Antimicrobial Modification Following Karius Spectrum Result Availability
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.
Time frame: From Karius Spectrum result availability through hospital discharge and up to 90 days following discharge (not to exceed 12 months).
Participants With Antimicrobial Modification
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.
Time frame: From enrollment through 90 days following discharge from the index hospitalization, up to 12 months
Number of Infection-Directed Microbiological Diagnostic Tests
Number of infection-directed microbiological diagnostic tests performed during the index encounter, summarized by test type.
Time frame: From Time Zero through discharge from the index hospitalization, up to 12 months
Invasive Diagnostic Procedures Ordered Following Karius Spectrum Result Availability
Number of invasive diagnostic procedures ordered following Karius Spectrum result availability, summarized by procedure type.
Time frame: From Karius Spectrum result availability through discharge from the index hospitalization, up to 12 months
Hospital Length of Stay From Admission
Hospital length of stay calculated as the number of days from admission to discharge from the index hospitalization.
Time frame: During the index hospitalization, from admission through discharge, up to 12 months
Incidence of Intensive Care Unit Transfer
Proportion of participants who experience transfer to an intensive care unit during the index hospitalization.
Time frame: During the index hospitalization, from admission through discharge, up to 12 months
Incidence of Mechanical Ventilation
Proportion of participants requiring mechanical ventilation during the index hospitalization.
Time frame: During the index hospitalization, from admission through discharge, up to 12 months
In-Hospital Mortality
Incidence of mortality during the index hospitalization.
Time frame: During the index hospitalization, from admission through discharge, up to 12 months
30-Day Mortality
Incidence of mortality within 30 days following hospital discharge.
Time frame: Through 30 days following hospital discharge.
30-Day Readmission
Incidence of hospital readmission within 30 days following hospital discharge.
Time frame: Through 30 days following hospital discharge.
Clostridioides difficile Infection
Incidence of Clostridioides difficile infection during the study period.
Time frame: Enrollment through 30 days following hospital discharge.
Immunosuppressive Therapy Modifications
Proportion of participants with any immunosuppressive therapy modification within a specified timeframe following usual-care or Karius Spectrum result availability.
Time frame: Baseline through 30 days following hospital discharge.
Species-Level Pathogen Identification by Karius Spectrum Compared With Usual Care
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.
Time frame: From Time Zero through discharge from the index hospitalization, up to 12 months
Antimicrobial Days
Number of days of antimicrobial therapy, summarized by antimicrobial spectrum, antimicrobial type, and route of administration.
Time frame: From enrollment through 90 days following discharge from the index hospitalization, up to 12 months
Number of Diagnostic Imaging Studies
Number of diagnostic imaging studies performed during the index encounter, summarized by imaging type.
Time frame: From Time Zero through discharge from the index hospitalization, up to 12 months
Number of Invasive Diagnostic Procedures
Number of invasive diagnostic procedures performed during the index encounter, including procedures such as needle aspiration and bronchoscopy.
Time frame: From Time Zero through discharge from the index hospitalization, up to 12 months
Invasive Diagnostic Procedures Cancelled Following Karius Spectrum Result Availability
Number of invasive diagnostic procedures cancelled following Karius Spectrum result availability, summarized by procedure type.
Time frame: From Karius Spectrum result availability through discharge from the index hospitalization, up to 12 months
Hospital Length of Stay From Time Zero
Hospital length of stay calculated as the number of days from Time Zero to discharge from the index hospitalization.
Time frame: From Time Zero through discharge from the index hospitalization, up to 12 months
Timing of Intensive Care Unit Transfer Relative to Time Zero
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.
Time frame: During the index hospitalization, from admission through discharge, up to 12 months
Timing of Mechanical Ventilation Relative to Time Zero
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.
Time frame: During the index hospitalization, from admission through discharge, up to 12 months
Ventilator Days
Number of ventilator-days among participants requiring mechanical ventilation.
Time frame: During the index hospitalization, from initiation of mechanical ventilation through discontinuation or discharge, up to 12 months
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Oct 2026; primary completion for Dec 2033, 86 months later.
Of 142 observational studies under Communicable Diseases, half reached primary completion within 37 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 94. This study's planned 86 months is above that.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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Karius, Inc.