Microbial Cell-free Metagenomic Sequencing for Suspected Infections in Adult Immunocompromised Outpatients
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorKarius, Inc.
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Basket Protocol* All participants must meet inclusion
Age ≥18
Included in one of the following immunocompromised groups: Solid organ transplant recipient (SOT) on chronic immunosuppression; Diagnosed with hematologic malignancy (HM) and/or recipient of a hematopoietic cell transplant (HCT); Diagnosed with a solid tumor and on specific types of active treatment; Recipient of drugs or novel biologics causing chronic immunosuppression; Diagnosed with an HIV infection; Diagnosed with inborn errors of immunity
Treating provider suspects infection and plans to obtain usual care diagnostic testing for the suspected infection (i.e., microbiologic testing)
Disqualifiers
Active symptoms are likely attributed to non-infectious causes.
Any other clinically significant medical condition that, in the opinion of the treating provider, makes participation undesirable, including but not limited to severe psychiatric illness, etc.
Patients who have been previously evaluated (including via telehealth) for the same clinical signs and symptoms at this institution and pathogen-directed usual care (UC), diagnostic testing was ordered during that prior encounter, with one or more diagnostic test results still pending.
Patients with a suspected or confirmed primary upper respiratory infection (e.g., viral pharyngitis, sinusitis, or uncomplicated bronchitis) unless there is clinical suspicion of a concurrent lower respiratory or systemic infection requiring further diagnostic evaluation.
Trial design
Design model
Single group
Treatments tested in this trial
Metagenomic plasma-based test for agnostic pathogen detection
Diagnostic testKarius Spectrum metagenomic plasma-based test.
Treatment groups
2,000 Participants
are divided into 2 treatment groupsGroup A: InterventionalExperimental treatment 1 intervention
Group B: ControlNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Time to Identification of a Pathogen Specific Etiology
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 frame
The 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.2
Time to Pathogen-Directed Treatment
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.
Time frame
The 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.Secondary outcomes
1
Duration of Antimicrobial Therapy
For each cohort, to evaluate whether the addition of Karius Spectrum testing to usual care reduces the total duration of antimicrobial therapy during the 30-day follow-up period, using data abstracted from the electronic medical record (e.g., medication administration records and provider documentation).
Time frame
30 days following enrollment.2
Percentage of participants receiving pathogen-directed treatment
For each cohort, to evaluate whether the addition of Karius Spectrum testing to usual care testing increases the proportion of participants ultimately receiving pathogen-directed treatment compared to usual care testing alone at specific time points (e.g., Day 3, Day 7, Day 14).
Time frame
30 days following enrollment.3
Time to Clinically Meaningful Detection (CMD)
For each cohort, to evaluate whether the addition of Karius Spectrum testing to usual care testing is associated with a reduction in time to clinically meaningful detection (CMD) compared to usual care testing alone. A CMD event is defined as the earliest identification of either (1) an etiological pathogen, or (2) a non-etiological pathogen that prompts a clinically meaningful action (e.g., treatment initiation, specialist referral, diagnostic escalation, or vascular access removal). Only the first qualifying CMD event per participant will be used for analysis.
Time frame
The 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.4
Number of Adverse Events
For all cohorts, the number of participants experiencing adverse events (AEs) and serious adverse events (SAEs) that are unexpected or related to the Karius Spectrum test or study procedures will be assessed. Events will be summarized by type, severity, and relationship to the study intervention.
Time frame
All AEs/SAEs will be collected from the time of blood draw through Day 30.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov