Microbial Cell-free Metagenomic Sequencing for Infections
(OPTIMUM Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests whether the Karius Spectrum™ test, a metagenomic plasma-based test, can diagnose infections more quickly in people with weakened immune systems. Participants will provide a blood sample; some will receive results from the new test alongside regular medical tests, while others will only undergo the regular tests. The trial aims to determine if this blood test speeds up infection diagnosis and treatment. Ideal candidates for this trial include individuals with conditions such as organ transplant, cancer, or HIV who suspect an infection requiring diagnosis. As an unphased study, this trial offers a unique opportunity to contribute to innovative research that could enhance infection diagnosis for many patients in the future.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It seems likely that you can continue your medications, especially since the trial involves a one-time blood sample and focuses on adding a new test to usual care.
What prior data suggests that the metagenomic plasma-based test is safe?
Research has shown that the Karius Spectrum test can detect over 1,000 different germs, including fungi, bacteria, and viruses, from just a blood sample. This method, called metagenomic sequencing, is quick and accurate. In terms of safety, participants in studies have generally tolerated the test well, as it requires only a single blood draw. No major issues have been directly linked to the test so far. This suggests the test is safe for humans, but discussing any concerns with a doctor before joining a trial is always advisable.12345
Why are researchers excited about this trial?
Researchers are excited about the metagenomic plasma-based test because it offers a unique approach to identifying infections. Unlike traditional methods that often rely on culturing pathogens, which can be time-consuming and sometimes ineffective for certain microbes, this test uses metagenomic sequencing to detect microbial DNA directly from plasma samples. This means it can potentially identify a wider range of pathogens faster and with greater accuracy. The ability to quickly determine the cause of an infection could lead to more targeted treatments and better patient outcomes.
What evidence suggests that the Karius Spectrum plasma test is effective for faster infection diagnosis in immunocompromised patients?
Research has shown that the Karius Spectrum test can quickly and accurately identify over 1,000 different germs, including fungi, bacteria, and viruses, using advanced DNA sequencing from a blood sample. In real-world use, this test improved patient outcomes in about 57% of cases by enabling doctors to diagnose infections faster and initiate targeted treatments sooner. For more than half of the patients, the test either confirmed an infection or ruled it out, leading to better treatment decisions. In this trial, participants in the interventional arm will receive Karius Spectrum test results, which have demonstrated promise in speeding up infection diagnosis—crucial for timely and appropriate treatment, especially for patients with weakened immune systems. Participants in the control arm will not receive these test results.12346
Who Is on the Research Team?
Kat Kwiatkowski, PhD
Principal Investigator
Karius, Inc.
Are You a Good Fit for This Trial?
Adults over 18 who are immunocompromised due to conditions like organ transplants, hematologic malignancies, solid tumors on treatment, chronic immunosuppression medication use, HIV infection or inborn errors of immunity. They must be suspected of having an infection and able to give blood for testing.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Enrollment and Sample Collection
Participants provide a blood sample for the Karius Spectrum test and usual care diagnostic tests
Follow-up
Participants are monitored for safety and effectiveness, and information about illness and treatments is recorded
Data Analysis
Analysis of time to pathogen-directed treatment and other outcomes
What Are the Treatments Tested in This Trial?
Interventions
- Metagenomic plasma-based test
Trial Overview
The trial is testing the Karius Spectrum™ plasma test's effectiveness in diagnosing infections faster when added to standard diagnostic tests among immunocompromised outpatients with suspected infections.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
This arm will receive Karius Spectrum test results.
This arm will not receive Karius Spectrum test results.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Karius, Inc.
Lead Sponsor
Citations
Karius Spectrum - Advanced Infectious Disease Blood Test
Karius Spectrum is an infectious disease blood test that uses next-generation sequencing to detect over 1000 pathogens with speed and accuracy.
Karius: Advanced Infectious Disease Diagnostics
Karius Spectrum TM is a blood test leveraging plasma metagenomic sequencing of microbial cell-free DNA to detect over 1,000 fungi, bacteria, DNA viruses, and ...
The Real-World Clinical Impact of Plasma mNGS Testing - PMC
The plasma mNGS results led to a positive impact in 83 (57.1%) patients by diagnosing or ruling out infection and initiating targeted therapy.
KPLA - Overview: Karius Spectrum, Plasma
Karius Spectrum blood test leverages metagenomic sequencing of microbial cell-fee DNA to detect over 1000 fungi, bacteria, DNA viruses, and ...
Study Details | NCT07110636 | Microbial Cell-free ...
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, ...
Clinical Performance of Plasma Metagenomic Sequencing ...
Plasma mNGS is described to have superior performance to conventional diagnostics and to change clinical management significantly in some studies.
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