Pneumonia in the ImmunoCompromised - Use of the Karius Test for the Detection of Undiagnosed Pathogens

Inclusion Criteria

• •Subjects must meet all of the criteria in Section A and all of the criteria in either Section B, Section C or Section D.
• •Section A:
• •1. Patient is ≥ 18 years of age.
• •2. Is currently admitted to the hospital.
• •3. Has a suspected infectious pneumonia warranting diagnostic evaluation and treatment.
• •4. Has undergone a diagnostic bronchoscopy for the evaluation of microbiologic etiology of pneumonia within 1 day prior to or has a scheduled bronchoscopy within 5 days following enrollment.
• •5. Patient or patient's Legally Authorized Representative (LAR) has provided consent for the study.
• •Section B:
• •1. Has one of the following hematologic malignancies: Acute Lymphoblastic Leukemia (ALL), Acute Myelogenous Leukemia (AML), Myelodysplastic Syndrome (MDS), Lymphoma (any type), Multiple Myeloma (MM) or malignant transformation of Chronic Lymphocytic Leukemia (CLL/SLL).
• •2. Are immunocompromised defined as having at least one of the following:
• •1. Received chemotherapy within the last 45 days.
• •2. A relapse of hematologic malignancy for which chemotherapy treatment is anticipated within the next 45 days.
• •3. ANC\<500 for a minimum of 14 days and within 8 weeks prior to enrollment.
• •Section C:
• •1. Has undergone autologous hematopoietic stem cell transplantation (e.g. bone marrow transplantation) for one of the following hematologic malignancies: Acute Lymphoblastic Leukemia (ALL), Acute Myelogenous Leukemia (AML), Myelodysplastic Syndrome (MDS), Lymphoma (any type), or Multiple Myeloma (MM);), or malignant transformation of Chronic Lymphocytic Leukemia (CLL/SLL).
• •2. Are immunocompromised defined as having at least one of the following:
• •1. Undergone autologous hematopoietic stem cell transplantation (HSCT) within the past 6 months.
• •2. Received chemotherapy within the last 45 days.
• •3. A relapse of hematologic malignancy for which chemotherapy treatment is anticipated within the next 45 days.
• •Section D:
• •1. Has undergone allogeneic hematopoietic stem cell transplantation (e.g., bone marrow transplantation) for any clinical indication.
• •2. Are immunocompromised defined as having at least one of the following:
• •1. Has undergone hematopoietic stem cell transplantation (HCST) within the past 1 year.
• •2. Has active graft versus host disease (GVHD) requiring immunosuppressive pharmacologic treatment.