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

Study acronym: OPTIMUM
StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. Notable Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 6
    • Start date changed from estimate of Sep 15, 2025 to Oct 27, 2025
    v3
  2. Notable Start date: Aug 15, 2025 to Sep 15, 2025
    • Primary completion date: Aug 15, 2028 to Sep 15, 2028
    v2
  3. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07110636
Lead Sponsor Karius, Inc.
Conditions
(from sponsor)
Infection, Infections, Bacterial, Infections, Fungal, Infection Viral, Parasitic Disease
Related terms Bacterial Infections, Infections, Mycoses, Parasitic Diseases, Virus Diseases
Enrollment 2,000 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov