Clinical trial · Observational
Metagenomic Sequencing Across the Infectious Disease Risk and Care Continuum
A Prospective, Multicenter Registry to Evaluate Metagenomic Sequencing Across the Infectious Disease Risk and Care Continuum
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 18, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260918-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Immunocompromised Host | — | UNRESOLVED | — |
| Infectious Diseases | — | UNRESOLVED | — |
| Opportunistic Infections | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (1)
- label
- Hospitalized Immunocompromised Adults With Suspected Lower Respiratory Infection
- description
- 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.
Primary outcomes (1)
- measure
- Time to Antimicrobial Modification Following Karius Spectrum Result Availability
- timeFrame
- From Karius Spectrum result availability through hospital discharge and up to 90 days following discharge (not to exceed 12 months).
- description
- 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.
Secondary outcomes (20)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available