NCT04047719

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 257 (actual)
• Sponsor: Karius, Inc. · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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 diagnosis of infectious diseases. We will compare the performance of the Karius Test to the results of microbiologic tests obtained as part of usual care for immunocompromised patients undergoing evaluation for suspected pneumonia.

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 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.

Conditions

• Pneumonia, Bacterial
• Pneumonia, Viral
• Pneumonia Fungal
• Pneumonia Cavitary
• Immunocompromised Host

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Karius Test	Karius Test for detection of microbial cell free DNA (mcfDNA) in plasma

Timeline

• Start date: 2019-11-05
• Primary completion: 2022-06-06
• Completion: 2022-06-06
• First posted: 2019-08-07
• Last updated: 2023-02-09

Locations

10 sites across 1 country: United States