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New treatment option for Infection
Official title Microbial Cell-free Metagenomic Sequencing for Suspected Infections in Adult Immunocompromised Outpatients
ClinicalTrials.gov ID: NCT07110636
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- Treating provider suspects infection and plans to obtain usual care diagnostic testing for the suspected infection (i.e., microbiologic testing)
- Willing to provide research samples via blood draw
You likely can't join if
- Basket Protocol\ All participants must not meet the following:
- 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...
- Patients who have been previously evaluated (including via telehealth) for the same clinical signs and symptoms at this institution and...
- Patients with a suspected or confirmed primary upper respiratory infection (e.g., viral pharyngitis, sinusitis, or uncomplicated bronchitis) unless...
- For Participants enrolled in Sub-Protocol B- Hematological Malignancies and Transplant\ All Sub-Protocol B people must not meet the following:
See the full eligibility criteria
- 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...
- Treating provider suspects infection and plans to obtain usual care diagnostic testing for the suspected infection (i.e., microbiologic testing)
- Willing to provide research samples via blood draw
- Willing and able to provide informed consent
- Presenting for evaluation in the outpatient setting (includes telehealth) \ For Participants enrolled in Sub-Protocol A- Solid Organ Transplant\ All Sub-Protocol A people must meet the following:
- Solid organ transplant recipient on transplant immunosuppression Non-lung recipients must meet one or more of the following characteristics: \<1 year from transplant; Augmented immunosuppression for suspected or...
- Suspected infection defined by one or more of the syndromes: Cardiac; Lower Respiratory; Gastrointestinal / Hepatobiliary; Genitourinary; Neurologic / Ophthalmologic; Skin / Soft tissue / musculoskeletal; Not Otherwise...
- For Participants enrolled in Sub-Protocol B- Hematological Malignancies and Transplant\ All Sub-Protocol B people must meet the following:
- Is included in at least one of the following groups: Hematologic malignancy (leukemia, myelodysplastic syndrome, lymphoma, multiple myeloma) and at least one of the following: Received chemotherapy or other systemic...
- Suspected infection defined by one or more of the syndromes: Cardiac; Lower Respiratory; Gastrointestinal / Hepatobiliary; Genitourinary; Neurologic / Ophthalmologic; Skin / Soft tissue / musculoskeletal; Not Otherwise...
- Basket Protocol\ All participants must not meet the following:
- 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. \ For Participants...
- 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...
- 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...
- For Participants enrolled in Sub-Protocol B- Hematological Malignancies and Transplant\ All Sub-Protocol B people must not meet the following:
- Patients that 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...
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- San Francisco, California, United States
- New Orleans, Louisiana, United States
- Boston, Massachusetts, United States
- Omaha, Nebraska, United States
- New York, New York, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include San Francisco, California, United States; New Orleans, Louisiana, United States; Boston, Massachusetts, United States; Omaha, Nebraska, United States; New York, New York, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.