RecruitingNot ApplicableNCT07110636

Microbial Cell-free Metagenomic Sequencing for Suspected Infections in Adult Immunocompromised Outpatients

A Prospective Randomized Basket Trial Evaluating the Clinical Utility of Plasma-based Microbial Cell-free Metagenomic Sequencing for Diagnosis and Management of Suspected Infections in Adult Immunocompromised Outpatients


Sponsor

Karius, Inc.

Enrollment

2,000 participants

Start Date

Oct 27, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

This clinical trial is designed to evaluate if adding the Karius Spectrum™ plasma test to usual care diagnostic tests, compared to usual care testing alone, among immunocompromised participants presenting with suspected infection in the outpatient setting leads to faster infection diagnosis and treatment. Participants will give a blood sample one time to be used for the testing. Information about the participant's illness and any treatments within 30 days following enrollment will be recorded.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying Metagenomic plasma-based test for agnostic pathogen detection for people with infection, infection viral, and other related conditions. The study is currently recruiting participants at 6 locations. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIAGNOSTIC_TESTMetagenomic plasma-based test for agnostic pathogen detection

Karius Spectrum metagenomic plasma-based test.


Locations(6)

University of California San Francisco

San Francisco, California, United States

Ochsner Medical Center

New Orleans, Louisiana, United States

Brigham and Women's Hospital

Boston, Massachusetts, United States

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

University of Nebraska Medical Center

Omaha, Nebraska, United States

Montefiore Medical Center

New York, New York, United States

View Full Details on ClinicalTrials.gov

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NCT07110636


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