Clinical Trial

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

Study acronym: OPTIMUM
Recruiting
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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.
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2025-07-30; most recent amendment 2026-01-28.
Status change: Not Yet Recruiting → Recruiting 2026-01-28
Trial Details
NCT Number NCT07110636
Lead Sponsor Karius, Inc.
Conditions Infection, Infections, Bacterial, Infections, Fungal, Infection Viral, Parasitic Disease
Enrollment 2,000 participants
Start Date 2025-10-27
Primary Completion 2028-09-15 (estimated)
Study Completion 2028-12-31 (estimated)
Updated on ClinicalTrials.gov 2026-01-30