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RECRUITING
NCT07110636
NA

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

Sponsor: Karius, Inc.

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

2000

Start Date

2025-10-27

Completion Date

2028-12-31

Last Updated

2026-01-30

Healthy Volunteers

No

Interventions

DIAGNOSTIC_TEST

Metagenomic 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