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NCT03846804 · ClinicalTrials.gov registry record · NA
Next-Generation Sequencing for Pathogen Detection and Quantification in Children With Musculoskeletal Infections
A NA study, sponsored by Indiana University.
- Completed
- Registry status
- NA
- Development phase
- 38
- Enrollment target
NCT03846804: Completed NA study, sponsored by Indiana University.
NCT03846804 is a NA study that has completed, run by Indiana University. The registered enrollment target is 38 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03846804, a NA study, has completed, sponsored by Indiana University.
- COMPLETED
- Registry status
- NA
- Development phase
- 38 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate the use of a blood test: Karius® plasma-based next-generation sequencing test (Karius Test), to see if we can detect and measure the infection causing agent in children with musculoskeletal infections (MSKI).
Primary Outcome
We evaluated the total number of participants that had a pathogen identified by the initial (IP1) Karius Test ("positive Karius Test"). We compared the results of the Karius Test to cultures (gold standard) for each participant. Karius Test results that matched cultures results (same genus and species) were considered "positive agreement". We also evaluated at the number of participants who had negative cultures, but had a positive Karius Test.
Interventions
- DIAGNOSTIC_TEST Karius Test
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 38 participants |
| Start Date | 2019-09-01 |
| Est. Completion | 2022-06-02 |
| Phase | NA |
What the finished NCT03846804 record still lists
NCT03846804 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 38 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower).
The record links to 0 conditions, and to 1 intervention - of which Karius Test is the first listed.
NCT03846804 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03846804 about?
NCT03846804 is a clinical study titled "Next-Generation Sequencing for Pathogen Detection and Quantification in Children With Musculoskeletal Infections". The purpose of this study is to evaluate the use of a blood test: Karius® plasma-based next-generation sequencing test (Karius Test), to see if we can detect and measure the infection causing agent in children with musculoskeletal infections (MSKI).
What is the current status of trial NCT03846804?
This trial is currently completed. It is a NA study. The enrollment target is 38 participants. The study started on 2019-09-01. Estimated completion is 2022-06-02.
What interventions are being tested in trial NCT03846804?
The interventions under investigation include: Karius Test (DIAGNOSTIC_TEST).
Who is sponsoring clinical trial NCT03846804?
This trial is sponsored by Indiana University, which has 890 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03846804's enrollment target sits among peer trials
38 1538th of 2000 higher than 461 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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