Metagenomic Sequencing Across the Infectious Disease Risk and Care Continuum

NCT07825714 | Not Yet Recruiting

• 1 other identifier: KAR-0040
• Study Type: observational
• Target: 10,000
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Infectious Diseases; Opportunistic Infections; Immunocompromised Host

Keywords

Metagenomic Sequencing; Microbial Cell-Free DNA; Karius Spectrum; Infectious Disease Diagnostics; Precision Diagnostics; Real-World Evidence; Observational Registry; Immunocompromised Host; Hematologic Malignancy; Solid Organ Transplant; Stem Cell Transplant; Opportunistic Infection; Diagnostic Stewardship; Clinical Decision Making; Healthcare Utilization

Outcome Measures

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.

  From Karius Spectrum result availability through hospital discharge and up to 90 days following discharge (not to exceed 12 months).

Secondary Outcomes (20)

• 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

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• 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.

You may not qualify if:

• Any condition that, in the opinion of the investigator, would make participation inappropriate or prevent completion of required study procedures.

Sponsors & Collaborators

• Karius, Inc.: lead

Biospecimen

Retention: SAMPLES WITH DNA

Residual ("leftover") clinical specimens collected as part of routine clinical care may be retained, where permitted by the reviewing Institutional Review Board (IRB). Biospecimens may include blood-derived specimens (including plasma and other blood components), respiratory specimens (including bronchoalveolar lavage and other site-specific specimens), and other clinically obtained specimens collected during routine infectious disease evaluation, surveillance, or monitoring. Retained specimens may be used for future molecular analyses, including characterization of microbial and host nucleic acids (DNA and RNA), and may be linked with associated clinical data as part of the AXIS interactome biobank.

MeSH Terms

Conditions

Communicable Diseases; Opportunistic Infections; Hematologic Neoplasms

Condition Hierarchy (Ancestors)

Infections; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Kat Kwiatkowski, PhD

  Karius, Inc.

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kat Kwiatkowsi

CONTACT

910-232-6396; kat.kwiatkowski@kariusdx.com

Mona Mughar

CONTACT

8653082690; mona.mughar@kariusdx.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 25, 2026
• First Posted: September 17, 2026
• Study Start: October 1, 2026
• Primary Completion (Estimated): December 1, 2033
• Study Completion (Estimated): December 1, 2033
• Last Updated: September 17, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share