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

Part of paid clinical trials in San Francisco, California.

Sponsor
Karius, Inc.
Study ID
NCT07110636
Status
Recruiting
Apply to this trial

Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Metagenomic plasma-based test for agnostic pathogen detection — DIAGNOSTIC_TEST
    Karius Spectrum metagenomic plasma-based test.

Study Details

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.

Key Dates

Start date
Oct 27, 2025
Status verified
Jan 2026
Primary completion
Sep 15, 2028
Completion
Dec 31, 2028

Study Design

Enrollment
2,000 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC

Arms

  • Experimental: Interventional
    This arm will receive Karius Spectrum test results.
  • No Intervention: Control
    This arm will not receive Karius Spectrum test results.

Primary Outcome Measure

Time to Identification of a Pathogen Specific Etiology [ Time Frame: The study sample will be collected within 24 hours of enrollment; participant information including usual care laboratory testing and treatments will be collected for 30 days following enrollment. ]

Central Contacts

Locations (6)

FacilityCityStateZIPSite coordinators
University of California San FranciscoSan FranciscoCalifornia94143
Monica Fung, MD
[email protected]
Ochsner Medical CenterNew OrleansLouisiana70121
Jonathan Hand, MD
[email protected]
Julie Castex, MSN
[email protected]
Beth Israel Deaconess Medical CenterBostonMassachusetts02215
Audrey H Mahajan, MD
[email protected]
617-632-7706
Dimitrios Farmakiotis, MD
[email protected]
(617) 632-7706
Audrey Mahajan, MD (PRINCIPAL_INVESTIGATOR)
Dimitrios Farmakiotis, MA (SUB_INVESTIGATOR)
Brigham and Women's HospitalBostonMassachusetts02115
Ann Woolley, MD
[email protected]
University of Nebraska Medical CenterOmahaNebraska68198
Carlos Gomez, MD
[email protected]
402-559-8650
Carlos Gomez, MA (PRINCIPAL_INVESTIGATOR)
Montefiore Medical CenterNew YorkNew York10467
Margaret McCort, MD
[email protected]

Find similar trials in San Francisco, CA

By research site
University of California San Francisco· San Francisco, CAOchsner Medical Center· New Orleans, LABeth Israel Deaconess Medical Center· Boston, MABrigham and Women's Hospital· Boston, MAUniversity of Nebraska Medical Center· Omaha, NEMontefiore Medical Center· New York, NY

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