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 : February 19, 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 or undergoing hematopoietic stem-cell transplantation. 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 : | November 30, 2020 |
| Estimated Study Completion Date : | December 31, 2020 |
| 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 at enrollment adjudicated as a definite or probable cause of the subject's index pneumonia event with no pathogen identified as a definite or probable cause of the subject's index pneumonia event from an adjudicated composite of all microbiologic test results performed per standard of care iwth 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:
Patients are eligible for the study if they meet all of the following criteria:
- ≥ 18 years of age
- Have one of the following hematologic malignancies: Acute Lymphoblastic Leukemia (ALL), Acute Myelogenous Leukemia (AML), Myelodysplastic Syndrome (MDS), Lymphoma (all types), or Multiple Myeloma (MM)
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Are immunocompromised defined as having at least one of the following:
- Received chemotherapy within the past 30 days
- Undergone hematopoietic stem cell transplantation (HSCT) within the past 1 year
- Active graft vs host disease (GVHD) requiring immunosuppressive pharmacologic treatment
- Are admitted to the hospital with suspected infectious pneumonia warranting diagnostic evaluation and treatment
- Have a planned diagnostic bronchoscopy or have undergone a diagnostic bronchoscopy for the evaluation of the microbiologic etiology of pneumonia within the 24 hours prior to enrollment
Exclusion Criteria:
Patients are not eligible for the study if they meet any of the following criteria:
- Patient or patient's legally authorized representative does not provide consent for the study
- 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 usual 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
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: Sudeb Dalai, MD, PhD | 650-409-5007 ext 167 | sudeb.dalai@kariusdx.com | |
| Contact: Stacy Meluskey, BS | 510-258-9079 | stacy.meluskey@kariusdx.com |
| United States, North Carolina | |
| Duke University | Recruiting |
| Durham, North Carolina, United States, 27710 | |
| Contact: Stephen Bergin 919-613-6394 stephen.bergin@duke.edu | |
| Contact: Matthew Kummerer 919-668-3135 Matthew.Kummerer@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: Joshua Kohl 412-648-6556 kohlj@upmc.edu | |
| Principal Investigator: Haidar Ghady, 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: Jacob Keane-Candib 206-667-6504 jkeaneca@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: | February 19, 2020 |
| Last Verified: | August 2019 |
| 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 |