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Status:

COMPLETED

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

Lead Sponsor:

Karius, Inc.

Collaborating Sponsors:

Duke Clinical Research Institute

Conditions:

Pneumonia, Bacterial

Pneumonia, Viral

Eligibility:

All Genders

18-80 years

Brief Summary

Given the need for a more sensitive pathogen detection test in patients with immunocompromised pneumonia, this study will evaluate the performance of the Karius Test, a novel NGS blood test for the di...

Detailed Description

Pneumonia is a major cause of morbidity and mortality in highly immunocompromised individuals such as patients with hematologic malignancies and/or hematopoietic stem cell transplant. These patients c...

Eligibility Criteria

Inclusion

  • 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:
  • Patient is ≥ 18 years of age.
  • Is currently admitted to the hospital.
  • Has a suspected infectious pneumonia warranting diagnostic evaluation and treatment.
  • 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.
  • Patient or patient's Legally Authorized Representative (LAR) has provided consent for the study.
  • Section B:
  • 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).
  • Are immunocompromised defined as having at least one of the following:
  • Received chemotherapy within the last 45 days.
  • A relapse of hematologic malignancy for which chemotherapy treatment is anticipated within the next 45 days.
  • ANC\<500 for a minimum of 14 days and within 8 weeks prior to enrollment.
  • Section C:
  • 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).
  • Are immunocompromised defined as having at least one of the following:
  • Undergone autologous hematopoietic stem cell transplantation (HSCT) within the past 6 months.
  • Received chemotherapy within the last 45 days.
  • A relapse of hematologic malignancy for which chemotherapy treatment is anticipated within the next 45 days.
  • Section D:
  • Has undergone allogeneic hematopoietic stem cell transplantation (e.g., bone marrow transplantation) for any clinical indication.
  • Are immunocompromised defined as having at least one of the following:
  • Has undergone hematopoietic stem cell transplantation (HCST) within the past 1 year.
  • Has active graft versus host disease (GVHD) requiring immunosuppressive pharmacologic treatment.

Exclusion

  • Patient is moribund and, in the opinion of the treating physician, is not expected to survive \>24 hours beyond the time of potential study enrollment visit.
  • Microbiologic etiology of index pneumonia event has already been identified per local Standard of Care testing.
  • Patient was previously enrolled in this study.
  • Patient has any condition that, in the opinion of the treating physician, will prevent the patient from completing the study. (Note: a qualified patient may still enroll in the study if they decline to have exploratory research sample collected.)
  • Patient is positive for SARS-COV-2 by any molecular testing within the 14 days prior to enrollment.

Key Trial Info

Start Date :

November 5 2019

Trial Type :

OBSERVATIONAL

Allocation :

ACTUAL

End Date :

June 6 2022

Estimated Enrollment :

257 Patients enrolled

Trial Details

Trial ID

NCT04047719

Start Date

November 5 2019

End Date

June 6 2022

Last Update

February 9 2023

Active Locations (10)

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Page 1 of 3 (10 locations)

1

City of Hope Comprehensive Cancer Center

Duarte, California, United States, 91010

2

UCSF Department of Medicine

San Francisco, California, United States, 94143

3

University of Colorado Denver

Aurora, Colorado, United States, 80045

4

Tulane Section of Infectious Disease

New Orleans, Louisiana, United States, 70112