Novel Diagnostics for Early Lyme Disease

Status unconfirmed

Conditions studied: Lyme Disease

In brief

There are more than 300,000 new cases of Lyme disease every year in the US. Lyme disease is a dangerous bacterial infection transmitted by tick bites and it becomes increasingly severe as the infection progresses. Definitive diagnosis is based on serum-based tests that have fundamental limitations: 1) current tests cannot detect early infections so patients do not receive antibiotic therapy until the infection has progressed, and 2) there is no way to measure if antibiotic therapy has been successful. MicroB-plex will address these two unmet clinical needs by introducing a novel, blood-based diagnostic method that will enable clinicians to diagnose infections earlier and to monitor the success of their interventions.

Key facts

Study ID

NCT03963635

Run by

MicroB-plex, Inc.

People needed

100

Starts

2019-05-01

Expected to finish

2020-12-31

Last updated by the study team

2019-08-13

Who can join

Age: 21 and older, up to 80. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Human adults at least 21 years of age and no more than 80 years of age at the time of screening.
• Have the ability to understand the requirements of the study, provide written informed consent (including consent for the use and disclosure of research-related health information), and comply with the study protocol procedures (including required study visits).
• High clinical suspicion of acute Lyme disease, with symptoms seven days or less.
• Must have erythema migrans rash and physician diagnosis of early Lyme disease.
• Brief history and physical exam will be obtained during the study visit.
• Be willing to return to our clinic for up to nine visits and blood draws over a one-year period.
• People who do not have Lyme disease, but want to participate as healthy controls (one time visit)

You may not qualify if…

• Have poor venous access.
• Have received any immunosuppressive therapy including biologics or recent course of steroids, or recent chemotherapy.
• Anti-TNF therapy (eg, adalimumab, etanercept, infliximab).
• Intravenous (IV) cyclophosphamide
• Interleukin-1 receptor antagonist (anakinra).
• Intravenous immunoglobulin (IVIG).
• High dose prednisone or equivalent (> 100 mg/day).
• Plasmapheresis.
• Any new immunosuppressive/immunomodulatory agent
• Any steroid injection (eg, intramuscular, intraarticular, or intravenous).
• On treatment for Lyme disease greater than seven days
• Recent chemotherapy
• History of solid organ transplant
• History of autoimmune disorders (SLE, Rheumatoid arthritis, Scleroderma, etc.)
• History of inflammatory muscle disease (polymyositis, dermatomyositis, etc.)
• History of inflammatory bowel disease (Crohn's disease, Ulcerative colitis, etc.)
• History of HIV infection
• Received a Lyme disease vaccine in the past
• History of prior Lyme disease infection in the past
• Have any condition that, in the opinion of the principal investigator, would significantly increase the risk for the subject.

Where it is running

• Johns Hopkins University School of Medicine — Baltimore, Maryland, United States (enrolling)

Full record on ClinicalTrials.gov

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