A Prospective Randomized Basket Trial Evaluating the Clinical Utility of Plasma-based Microbial Cell-free Metagenomic Sequencing for Diagnosis and Management of Suspected Infections in Adult Immunocompromised Outpatients

What this Trial Is About

Researchers are evaluating whether adding the Karius Spectrum12 plasma test to standard diagnostic tests helps diagnose infections faster in immunocompromised adults seen in outpatient settings. The study compares usual care testing alone to usual care plus the Karius Spectrum test, which detects many types of microbial pathogens from a blood sample. The trial includes two groups: solid organ transplant patients and those with hematologic malignancies or related treatments. Participants are randomly assigned to receive either the Karius Spectrum test results alongside usual care or usual care testing alone. The Karius Spectrum test analyzes microbial cell-free DNA in plasma to identify over 1,000 pathogens, including bacteria, viruses, fungi, and parasites. The study is designed as a basket trial to assess this testing approach across multiple high-risk immunocompromised populations with suspected infections. Participants provide a one-time blood sample within 24 hours of enrollment and are followed for 30 days to record illness information, usual care lab tests, treatments, and any adverse events. Researchers measure the time to identify a pathogen, start targeted treatment, antimicrobial therapy duration, and the proportion of patients receiving pathogen-directed therapy. Safety data are collected through day 30, with participant outcomes tracked in the outpatient setting including telehealth visits.

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