Karius Spectrum™ Test for Infections in Immunocompromised Outpatients
This study is looking at whether adding the Karius Spectrum™ plasma test to standard diagnostic tests can help doctors find and treat infections faster in adults who have weakened immune systems (immunocompromised). This includes people who have had organ transplants, certain cancers, or stem cell transplants. The Karius Spectrum™ test is a blood test that looks for genetic material from different germs (bacteria, fungi, viruses, parasites) to identify what might be causing an infection. Researchers want to see if using this test, compared to usual care alone, leads to quicker identification of the specific germ causing the infection and faster targeted treatment. The study plans to enroll 2000 participants.
- Study design
- This is an interventional study that compares the Karius Spectrum™ test plus usual care to usual care alone. It is designed as a basket trial, meaning it includes different groups of immunocompromised patients.
- What's involved
- You would provide a single blood sample for the Karius Spectrum™ test. Information about your illness and treatments will be collected for 30 days after you join the study.
- Compensation
- Not stated in the trial record.
- Follow-up
- Your information, including usual care laboratory testing and treatments, will be collected for 30 days following enrollment.
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Microbial Cell-free Metagenomic Sequencing for Suspected Infections in Adult Immunocompromised Outpatients
At a glance
Conditions
Where it's being run
6 sites across 5 statesStudy leadership
- Kat Kwiatkowski, PhD · PRINCIPAL_INVESTIGATOR · Karius, Inc.
Who to contact
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Do you actually qualify for this trial?
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Inclusion
Exclusion
What this trial measures
- Time to Identification of a Pathogen Specific EtiologyThe 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.
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.
- Time to Pathogen-Directed TreatmentThe 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.
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.