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NCT04047719 · ClinicalTrials.gov registry record
Pneumonia in the ImmunoCompromised - Use of the Karius Test for the Detection of Undiagnosed Pathogens
A clinical trial, sponsored by Karius.
- Completed
- Registry status
- 257
- Enrollment target
NCT04047719: Completed study, sponsored by Karius.
NCT04047719 is a clinical trial that has completed, run by Karius. The registered enrollment target is 257 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04047719 has completed, sponsored by Karius.
- COMPLETED
- Registry status
- 257 participants
- Enrollment target
Study 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.
Primary Outcome
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.
Interventions
- DIAGNOSTIC_TEST Karius Test
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 257 participants |
| Start Date | 2019-11-05 |
| Est. Completion | 2022-06-06 |
What the finished NCT04047719 record still lists
NCT04047719 is an observational study that tracks outcomes without assigning an intervention. The registered 257 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 1 intervention - of which Karius Test is the first listed.
NCT04047719 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04047719 about?
NCT04047719 is a clinical study titled "Pneumonia in the ImmunoCompromised - Use of the Karius Test for the Detection of Undiagnosed Pathogens". 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...
What is the current status of trial NCT04047719?
This trial is currently completed. The enrollment target is 257 participants. The study started on 2019-11-05. Estimated completion is 2022-06-06.
What interventions are being tested in trial NCT04047719?
The interventions under investigation include: Karius Test (DIAGNOSTIC_TEST).
Who is sponsoring clinical trial NCT04047719?
This trial is sponsored by Karius, which has 7 total clinical trials registered on ClinicalTrials.gov.
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