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NCT03581279 · ClinicalTrials.gov registry record · NA
Detection of Borrelia Bacteria in Early Stage Lyme Borreliosis Using the T2Lyme Panel
A NA study, sponsored by T2 Biosystems.
- Terminated
- Registry status
- NA
- Development phase
- 18
- Enrollment target
NCT03581279: Clinical Trial NA study, sponsored by T2 Biosystems.
NCT03581279 is a NA study that was terminated before completion, run by T2 Biosystems. The registered enrollment target is 18 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03581279, a NA study, was terminated before completion, sponsored by T2 Biosystems.
- TERMINATED
- Registry status
- NA
- Development phase
- 18 participants
- Enrollment target
Study Summary
The T2Lyme assay will be compared to Borrelia culture from erythema migrans (EM) biopsy and/or detection of the C6 antigen in serum collected prospectively from patients suspected of early Lyme disease.
Primary Outcome
Qualitative detection of genetic material (DNA) from the major causative agents of Lyme disease (Borrelia burgdorferi, Borrelia afzelii, Borrelia garinii, as well as inclusive Borrelia spp.) from K2EDTA human whole blood samples using the T2Dx instrument and T2Lyme reagents.
Interventions
- DEVICE T2Lyme Panel testing
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 18 participants |
| Start Date | 2018-05-08 |
| Est. Completion | 2019-10-31 |
| Phase | NA |
Why NCT03581279 stopped before completion
NCT03581279 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 18 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 1 intervention - of which T2Lyme Panel testing is the first listed.
NCT03581279 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03581279 about?
NCT03581279 is a clinical study titled "Detection of Borrelia Bacteria in Early Stage Lyme Borreliosis Using the T2Lyme Panel". The T2Lyme assay will be compared to Borrelia culture from erythema migrans (EM) biopsy and/or detection of the C6 antigen in serum collected prospectively from patients suspected of early Lyme disease.
What is the current status of trial NCT03581279?
This trial is currently terminated. It is a NA study. The enrollment target is 18 participants. The study started on 2018-05-08. Estimated completion is 2019-10-31.
What interventions are being tested in trial NCT03581279?
The interventions under investigation include: T2Lyme Panel testing (DEVICE).
Who is sponsoring clinical trial NCT03581279?
This trial is sponsored by T2 Biosystems, which has 7 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03581279's enrollment target sits among peer trials
18 1863rd of 2000 higher than 130 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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