NCT03581279 is a NA clinical trial of T2Lyme Panel testing in Lyme Disease, sponsored by T2 Biosystems.

Who is sponsoring NCT03581279?

NCT03581279 is sponsored by T2 Biosystems.

What drugs are being tested in NCT03581279?

Interventions in NCT03581279: T2Lyme Panel testing.

What condition does NCT03581279 study?

NCT03581279 studies Lyme Disease.

Is NCT03581279 still recruiting?

NCT03581279 is currently terminated. Last updated 4 February 2022.

Are results published for NCT03581279?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2022-02-04 · How we verify

NCT03581279

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Detection of Borrelia Bacteria in Early Stage Lyme Borreliosis Using the T2Lyme Panel

Terminated NA Results posted Last updated 4 February 2022

What this trial tests

NA trial testing T2Lyme Panel testing in Lyme Disease in 18 participants. Terminated before completion.

Timeline

8 May 2018

Primary endpoint
31 October 2019

31 October 2019

Quick facts

Lead sponsor	T2 Biosystems
Phase	NA
Status	Terminated
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	triple
Primary purpose	diagnostic
Enrollment	18
Start date	8 May 2018
Primary completion	31 October 2019
Estimated completion	31 October 2019
Sites	2 locations across United States

Drugs / interventions tested

T2Lyme Panel testing

Conditions studied

Lyme Disease — all drugs for Lyme Disease →

Sponsor

T2 Biosystems

Who can join

18 and older, any sex, with Lyme Disease. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Participants With Lyme Disease Detected in Human Whole Blood Samples Primary · 1 day

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.

Group	Value	95% CI
EM Present	18
No EM Present	0

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

Verify or expand the search:

Other recruiting trials for Lyme Disease

Currently open trials in the same condition.

NCT06045416 — Borrelia B-cell Diagnostics · recruiting
NCT06397794 — Navigating Pregnancy and Parenthood With Lyme Disease · recruiting
NCT05477524 — An Efficacy, Safety, Tolerability, Immunogenicity, and Lot-Consistency Clinical Trial of a 6-Valent OspA-Based Lyme Dise · Phase 3 · active not recruiting
NCT05036707 — Human Immune Response to Ixodes Scapularis Tick Bites · Phase 1, PHASE2 · recruiting
NCT04402086 — Rheumatology Patient Registry and Biorepository · recruiting

Other T2 Biosystems trials

Trials by the same sponsor.

NCT05231187 — T2Resistance - Detection of Resistance Related Genes · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03581279 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by T2 Biosystems
Last refreshed: 4 February 2022

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03581279.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing