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

NCT07110636 | Recruiting

• 1 other identifier: KAR-0025
• Study Type: interventional
• Target: 2,000
• Locations: 1 country
• Sites: 6

Brief 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

Keywords

Karius; Karius Spectrum; Infection detection; metagenomic testing; Pathogen detection; Bacterial Infection; Fungal Infection; Parasitic Infection; Viral Infection

Outcome Measures

Primary Outcomes (2)

• Time to Identification of a Pathogen Specific Etiology

  For each cohort, to evaluate whether the addition of Karius Spectrum testing to usual care testing reduces the time to identification of a pathogen-specific etiology, compared to usual care testing alone, in participants with suspected infection in the outpatient setting.

  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.

• Time to Pathogen-Directed Treatment

  For each cohort, to evaluate whether the addition of the Karius Spectrum test to usual care testing reduces the time to pathogen-directed treatment compared to usual care testing alone.

  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.

Secondary Outcomes (4)

• Duration of Antimicrobial Therapy

  30 days following enrollment.

• Percentage of participants receiving pathogen-directed treatment

  30 days following enrollment.

• Time to Clinically Meaningful Detection (CMD)

  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.

• Number of Adverse Events

  All AEs/SAEs will be collected from the time of blood draw through Day 30.

Study Arms (2)

Interventional

EXPERIMENTAL

This arm will receive Karius Spectrum test results.

Diagnostic Test: Metagenomic plasma-based test for agnostic pathogen detection

Control

NO INTERVENTION

This arm will not receive Karius Spectrum test results.

Interventions

Metagenomic plasma-based test for agnostic pathogen detection DIAGNOSTIC_TEST

Karius Spectrum metagenomic plasma-based test.

Interventional

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥18
• Included in one of the following immunocompromised groups: Solid organ transplant recipient (SOT) on chronic immunosuppression; Diagnosed with hematologic malignancy (HM) and/or recipient of a hematopoietic cell transplant (HCT); Diagnosed with a solid tumor and on specific types of active treatment; Recipient of drugs or novel biologics causing chronic immunosuppression; Diagnosed with an HIV infection; Diagnosed with inborn errors of immunity
• Treating provider suspects infection and plans to obtain usual care diagnostic testing for the suspected infection (i.e., microbiologic testing)
• Willing to provide research samples via blood draw
• Willing and able to provide informed consent
• Presenting for evaluation in the outpatient setting (includes telehealth)
• \*For Participants enrolled in Sub-Protocol A- Solid Organ Transplant\*
• All Sub-Protocol A subjects must meet the following:
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• Solid organ transplant recipient on transplant immunosuppression Non-lung recipients must meet one or more of the following characteristics: \<1 year from transplant; Augmented immunosuppression for suspected or confirmed rejection within the last 6 months; Confirmed systemic infection in last 6 months
• Suspected infection defined by one or more of the syndromes: Cardiac; Lower Respiratory; Gastrointestinal / Hepatobiliary; Genitourinary; Neurologic / Ophthalmologic; Skin / Soft tissue / musculoskeletal; Not Otherwise Specified
• For Participants enrolled in Sub-Protocol B- Hematological Malignancies and Transplant\* All Sub-Protocol B subjects must meet the following:
• Is included in at least one of the following groups: Hematologic malignancy (leukemia, myelodysplastic syndrome, lymphoma, multiple myeloma) and at least one of the following: Received chemotherapy or other systemic anti-cancer therapy associated with immunosuppressive effects within 90 days (e.g., monoclonal antibodies associated with B-cell or plasma cell depletion, bi-specific t-cell engagers, BTK inhibitors, BCL-2 inhibitors, PI3K inhibitors) within the last 90 days Note: Checkpoint inhibitors are not included unless given in combination with an immunosuppressive agent; Relapsed disease with chemotherapy anticipated in 60 days; ANC \<500 within the last 72 hours; Hypogammaglobulinemia IgG \<400 within the last 30 days; Allogeneic stem cell transplant for any clinical indication and at least one of the following: Within 1-year post-transplant; On systemic immunosuppressive therapy for GVHD treatment or prophylaxis; Autologous stem cell transplant for hematologic malignancy and at least one of the following: Within 6 months post-transplant; ANC \<500 within the last 72 hours; B cell and plasma cell targeted CAR-T therapy for hematologic malignancy and at least one of the following: Within 6 months of CAR-T cell infusion; CD4 T-cell \<200 within the last 30 days; IgG \< 400 within the last 30 days; ANC \<500 within the last 72 hours; On systemic immunosuppressive therapy for CRS/ICANS
• Suspected infection defined by one or more of the syndromes: Cardiac; Lower Respiratory; Gastrointestinal / Hepatobiliary; Genitourinary; Neurologic / Ophthalmologic; Skin / Soft tissue / musculoskeletal; Not Otherwise Specified

You may not qualify if:

• Basket Protocol\* All participants must not meet the following:
• Active symptoms are likely attributed to non-infectious causes.
• Any other clinically significant medical condition that, in the opinion of the treating provider, makes participation undesirable, including but not limited to severe psychiatric illness, etc.
• \*For Participants enrolled in Sub-Protocol A- Solid Organ Transplant\*
• All Sub-Protocol A subjects must not meet the following:
• <!-- -->
• Patients who have been previously evaluated (including via telehealth) for the same clinical signs and symptoms at this institution and pathogen-directed usual care (UC), diagnostic testing was ordered during that prior encounter, with one or more diagnostic test results still pending.
• Patients with a suspected or confirmed primary upper respiratory infection (e.g., viral pharyngitis, sinusitis, or uncomplicated bronchitis) unless there is clinical suspicion of a concurrent lower respiratory or systemic infection requiring further diagnostic evaluation.
• For Participants enrolled in Sub-Protocol B- Hematological Malignancies and Transplant\* All Sub-Protocol B subjects must not meet the following:
• Patients that have been previously evaluated (including via telehealth) for the same clinical signs and symptoms at this institution and pathogen-directed usual care (UC) diagnostic testing was ordered during that prior encounter with one or more diagnostic tests results still pending.
• Patients with a suspected or confirmed primary upper respiratory infection (e.g., viral pharyngitis, sinusitis, or uncomplicated bronchitis) unless there is clinical suspicion of a concurrent lower respiratory or systemic infection requiring further diagnostic evaluation.

Sponsors & Collaborators

• Karius, Inc.: lead

Study Sites (6)

University of California San Francisco

San Francisco, California, 94143, United States

NOT YET RECRUITING

Ochsner Medical Center

New Orleans, Louisiana, 70121, United States

RECRUITING

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

RECRUITING

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

RECRUITING

University of Nebraska Medical Center

Omaha, Nebraska, 68198, United States

RECRUITING

Montefiore Medical Center

New York, New York, 10467, United States

NOT YET RECRUITING

MeSH Terms

Conditions

Infections; Bacterial Infections; Mycoses; Virus Diseases; Parasitic Diseases

Condition Hierarchy (Ancestors)

Bacterial Infections and Mycoses

Study Officials

• Kat Kwiatkowski, PhD

  Karius, Inc.

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kat Kwiatkowski, PhD

CONTACT

866-452-7487; kat.kwiatkowski@kariusdx.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Both the interventional group and control group will undergo a blood draw. The interventional group will receive Karius Spectrum test results. The control group will not receive Karius Spectrum test results.

Study Record Dates

• First Submitted: June 17, 2025
• First Posted: August 7, 2025
• Study Start: October 27, 2025
• Primary Completion (Estimated): September 15, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: January 30, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (6)