Actively Recruiting
Microbial Cell-free Metagenomic Sequencing for Suspected Infections in Adult Immunocompromised Outpatients
Led by Karius, Inc. · Updated on 2026-01-30
2000
Participants Needed
6
Research Sites
165 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Microbial Cell-free Metagenomic Sequencing for Suspected Infections in Adult Immunocompromised Outpatients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Immunocompromised as one of the following: solid organ transplant recipient on chronic immunosuppression; diagnosed with hematologic malignancy and/or recipient of hematopoietic cell transplant; diagnosed with solid tumor on specific active treatments; recipient of drugs or novel biologics causing chronic immunosuppression; diagnosed with HIV infection; diagnosed with inborn errors of immunity
- Treating provider suspects infection and plans to obtain usual care diagnostic testing
- Willing to provide research samples via blood draw
- Willing and able to provide informed consent
- Presenting for evaluation in the outpatient setting, including telehealth
- For solid organ transplant patients: on transplant immunosuppression and either less than 1 year from transplant, or had augmented immunosuppression for suspected or confirmed rejection within last 6 months, or confirmed systemic infection in last 6 months
- For hematologic malignancy and transplant patients: diagnosed with hematologic malignancy and received immunosuppressive chemotherapy within last 90 days or have relapsed disease with chemotherapy planned, or low neutrophil count (ANC <500) recently, or low IgG levels recently, or received stem cell transplant with specified risk factors, or received CAR-T therapy with specified risk factors
- Suspected infection defined by one or more of these syndromes: cardiac; lower respiratory; gastrointestinal/hepatobiliary; genitourinary; neurologic/ophthalmologic; skin/soft tissue/musculoskeletal; not otherwise specified
You will not qualify if you...
- Active symptoms likely caused by non-infectious conditions
- Any other clinically significant medical condition making participation undesirable, including severe psychiatric illness
- For solid organ transplant patients: previously evaluated for the same symptoms at this institution with pending diagnostic test results
- For solid organ transplant patients: suspected or confirmed primary upper respiratory infection unless there is clinical suspicion of a concurrent lower respiratory or systemic infection
- For hematologic malignancy and transplant patients: previously evaluated for the same symptoms at this institution with pending diagnostic test results
- For hematologic malignancy and transplant patients: suspected or confirmed primary upper respiratory infection unless there is clinical suspicion of a concurrent lower respiratory or systemic infection
AI-Screening
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Trial Site Locations
Total: 6 locations
1
University of California San Francisco
San Francisco, California, United States, 94143
Not Yet Recruiting
2
Ochsner Medical Center
New Orleans, Louisiana, United States, 70121
Actively Recruiting
3
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Actively Recruiting
4
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Actively Recruiting
5
University of Nebraska Medical Center
Omaha, Nebraska, United States, 68198
Actively Recruiting
6
Montefiore Medical Center
New York, New York, United States, 10467
Not Yet Recruiting
Research Team
K
Kat Kwiatkowski, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
2
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