Metagenomic Sequencing Across the Infectious Disease Risk and Care Continuum
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorKarius, Inc.
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial population
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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
10,000 Participants
are grouped into 1 trial groupGroup A: Hospitalized Immunocompromised Adults With Suspected Lower Respiratory Infection
Trial outcomes
Primary outcomes
1
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).Secondary outcomes
1
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 months2
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 months3
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 months4
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 monthsLocations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
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