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

NCT07110636 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 2000

Last updated 2026-01-30

No results posted yet for this study

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.

Conditions

  • Infection
  • Infections, Bacterial
  • Infections, Fungal
  • Infection Viral
  • Parasitic Disease

Interventions

DIAGNOSTIC_TEST

Metagenomic plasma-based test for agnostic pathogen detection

Karius Spectrum metagenomic plasma-based test.

Sponsors & Collaborators

  • Karius, Inc.

    lead INDUSTRY

Principal Investigators

  • Kat Kwiatkowski, PhD · Karius, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-10-27
Primary Completion
2028-09-15
Completion
2028-12-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07110636 on ClinicalTrials.gov