Pneumonia in the ImmunoCompromised - Use of the Karius Test for the Detection of Undiagnosed Pathogens (PICKUP)
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| ClinicalTrials.gov Identifier: NCT04047719 |
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Recruitment Status :
Recruiting
First Posted : August 7, 2019
Last Update Posted : December 30, 2020
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| Condition or disease | Intervention/treatment |
|---|---|
| Pneumonia, Bacterial Pneumonia, Viral Pneumonia Fungal Pneumonia Cavitary Immunocompromised Host | Diagnostic Test: Karius Test |
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 can be infected by a broad range of potential pathogens, including viral, bacterial, and fungal etiologies and sometimes with multiple pathogens simultaneously. Diagnostic testing often fails to identify a microbial etiology for lower respiratory illness even with bronchoalveolar lavage (BAL). In fact, culture methods, PCR, and antigen testing on BAL samples yields a positive result only 30-67% of the time. Additionally, Idiopathic Pulmonary Syndrome (IPS), a non-infectious pulmonary complication of transplant, can have many overlapping symptoms with infectious pneumonia. Treatment for IPS is administration of steroids which can exacerbate infections. Given these reasons, there is a need for better diagnostics to aid in the management of immunocompromised patients with pneumonia.
Karius has developed a microbial cell-free plasma next-generation sequencing test for pathogen detection capable of detecting >1,000 organisms including DNA viruses, bacteria, yeasts, molds, and other eukaryotic pathogens. The test is performed in a CLIA-certified/CAP-accredited laboratory with results typically provided within one day from sample receipt. Given the need for a more sensitive diagnostic test for pneumonia in this population, we are evaluating the performance of the Karius Test for pathogen detection.
| Study Type : | Observational |
| Estimated Enrollment : | 195 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| Official Title: | Pneumonia in the ImmunoCompromised - Use of the Karius Test for the Detection of Undiagnosed Pathogens |
| Actual Study Start Date : | November 5, 2019 |
| Estimated Primary Completion Date : | June 30, 2021 |
| Estimated Study Completion Date : | December 31, 2021 |
| Group/Cohort | Intervention/treatment |
|---|---|
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Intent-to-Diagnose Population
All subjects enrolled in the study that have at least one Karius Test with a valid result
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Diagnostic Test: Karius Test
Karius Test for detection of microbial cell free DNA (mcfDNA) in plasma |
- Additive clinical diagnostic value [ Time Frame: 7 days ]Percent of patients with ≥1 pathogen identified by the Karius Test collected at enrollment that is adjudicated as a probable cause of the subject's index pneumonia event with no pathogen identified as a probable cause of the subject's index pneumonia event from an adjudicated composite of all microbiologic test results performed per Standard of Care with results available within 7 days of study enrollment.
Biospecimen Retention: Samples With DNA
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| Ages Eligible for Study: | 18 Years to 80 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
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:
- 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).
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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).
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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.
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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 Criteria:
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04047719
| Contact: Asim Ahmed, MD | 650-409-5007 ext 174 | asim.ahmed@kariusdx.com | |
| Contact: Jeanette Braaten, BS | 650-409-5007 ext 226 | jeanette.braaten@kariusdx.com |
| United States, California | |
| City of Hope Comprehensive Cancer Center | Recruiting |
| Duarte, California, United States, 91010 | |
| Principal Investigator: Sanjeet Dadwal, MD | |
| UCSF Department of Medicine | Recruiting |
| San Francisco, California, United States, 94143 | |
| Principal Investigator: Peter Chin-Hong, MD | |
| Sub-Investigator: Monica Fung, MD | |
| United States, Louisiana | |
| Tulane Section of Infectious Disease | Recruiting |
| New Orleans, Louisiana, United States, 70112 | |
| Contact: Alfred Luk, MD 504-988-7316 aluk@tulane.edu | |
| Principal Investigator: Alfred Luk, MD | |
| United States, North Carolina | |
| Duke University | Recruiting |
| Durham, North Carolina, United States, 27710 | |
| Contact: Stephen Bergin, MD 919-613-6394 stephen.bergin@duke.edu | |
| Contact: Allie L Frear 919-684-8914 allie.frear@duke.edu | |
| Principal Investigator: Stephen Bergin, MD | |
| United States, Pennsylvania | |
| University of Pittsburgh | Recruiting |
| Pittsburgh, Pennsylvania, United States, 15025 | |
| Contact: Ghady Haidar, MD 412-648-6212 haidar@upmc.edu | |
| Contact: Wendy Liang 412-648-6536 liangw3@upmc.edu | |
| Principal Investigator: Haidar Ghady, MD | |
| United States, Texas | |
| MD Anderson Cancer Center | Recruiting |
| Houston, Texas, United States, 77030 | |
| Contact: Samantha Trager 713-745-6263 SCZarda@mdanderson.org | |
| Principal Investigator: Roy Chemaly, MD | |
| United States, Washington | |
| Fred Hutchinson Cancer Center | Recruiting |
| Seattle, Washington, United States, 98109 | |
| Contact: Joshua Hill, MD 206-667-6504 jahill13@fredhutch.org | |
| Contact: Rina Romano 206-667-6709 rromano@fredhutch.org | |
| Principal Investigator: Joshua Hill, MD | |
| Principal Investigator: | Stephen Bergin, MD | Duke University |
| Responsible Party: | Karius, Inc. |
| ClinicalTrials.gov Identifier: | NCT04047719 |
| Other Study ID Numbers: |
KDC-010 |
| First Posted: | August 7, 2019 Key Record Dates |
| Last Update Posted: | December 30, 2020 |
| Last Verified: | December 2020 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Undecided |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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Pneumonia NGS cell free DNA microbial cell free DNA immunocompromised |
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Pneumonia, Bacterial Pneumonia, Viral Pneumonia Lung Diseases |
Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases Bacterial Infections |