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NCT07110636 · ClinicalTrials.gov registry record · NA

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

A NA study of Infection and Parasitic Disease, sponsored by Karius.

Recruiting
Registry status
NA
Development phase
2,000
Enrollment target
6
Study locations

NCT07110636 is a NA study of Infection and Parasitic Disease that is actively recruiting participants, run by Karius. The registered enrollment target is 2,000 participants, above the 678-participant average among 41 other Infection trials with a reported enrollment target (195% higher). The trial reports 6 study locations across 5 states.

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The verdict

NCT07110636, a NA study of Infection and Parasitic Disease, is actively recruiting participants, sponsored by Karius.

RECRUITING
Registry status
NA
Development phase
2,000 participants
Enrollment target
6
Study locations

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.

Interventions

  • DIAGNOSTIC_TEST Metagenomic plasma-based test for agnostic pathogen detection

Study Locations (6)

Massachusetts

  • Brigham and Women's Hospital - Boston
  • Beth Israel Deaconess Medical Center - Boston

California

  • University of California San Francisco - San Francisco

Louisiana

  • Ochsner Medical Center - New Orleans

Nebraska

  • University of Nebraska Medical Center - Omaha

New York

  • Montefiore Medical Center - New York

Trial Details

FieldValue
Enrollment Target 2,000 participants
Start Date 2025-10-27
Est. Completion 2028-12-31
Phase NA

Sponsor

Karius

7 total trials

What the Registry Record Tells You About NCT07110636

The ClinicalTrials.gov registry entry for NCT07110636 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 2,000 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 678-participant average among 41 other Infection trials with a reported enrollment target (195% higher). The listed sponsor is Karius, which has 7 total studies on file at ClinicalTrials.gov.

The record links to 5 conditions, with Infection appearing as the primary indexed condition, and to 1 intervention - of which Metagenomic plasma-based test for agnostic pathogen detection is the first listed.

NCT07110636 reports 6 study locations spanning 5 distinct geographic areas - top geographies include Massachusetts, California, Louisiana.

Frequently Asked Questions

What is clinical trial NCT07110636 about?

NCT07110636 is a clinical study titled "Microbial Cell-free Metagenomic Sequencing for Suspected Infections in Adult Immunocompromised Outpatients". 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 trea...

What is the current status of trial NCT07110636?

This trial is currently recruiting. It is a NA study. The enrollment target is 2,000 participants. The study started on 2025-10-27. Estimated completion is 2028-12-31.

What conditions does trial NCT07110636 study?

This clinical trial studies the following conditions: Infection, Parasitic Disease, Infections, Bacterial, Infections, Fungal, Infection Viral.

What interventions are being tested in trial NCT07110636?

The interventions under investigation include: Metagenomic plasma-based test for agnostic pathogen detection (DIAGNOSTIC_TEST).

Who is sponsoring clinical trial NCT07110636?

This trial is sponsored by Karius, which has 7 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT07110636 being conducted?

This trial has 6 study locations across California, Louisiana, Massachusetts, Nebraska, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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