Recruiting

Diagnostics

Sponsor:

MicroB-plex, Inc.

Code:

NCT03963635

Conditions

Lyme Disease

Eligibility Criteria

Sex: All

Age: 21 - 70+

Healthy Volunteers: Accepted

Interventions

MicroB-plex Lyme Immunoassay

Study Details

Brief summary:

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.

Conditions

Lyme Disease

Study ID

NCT03963635

Start date

May 1, 2019

Status verified date

Aug, 2019

Completion date

Dec 31, 2020

Anticipated

Primary completion date

Dec 31, 2020

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21 - 70+

Healthy Volunteers: Accepted

Inclusion Criteria:

1. Human adults at least 21 years of age and no more than 80 years of age at the time of screening.
2. 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).
3. High clinical suspicion of acute Lyme disease, with symptoms seven days or less.
4. Must have erythema migrans rash and physician diagnosis of early Lyme disease.
5. Brief history and physical exam will be obtained during the study visit.
6. Be willing to return to our clinic for up to nine visits and blood draws over a one-year period.
7. People who do not have Lyme disease, but want to participate as healthy controls (one time visit)

Exclusion Criteria:

1. Have poor venous access.
2. Have received any immunosuppressive therapy including biologics or recent course of steroids, or recent chemotherapy.

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

Study Design

Enrollment

100 participants

Anticipated

Interventions and Outcome Measures

Arms

Lyme Infected

Subjects presenting with suspected Lyme Disease

Controls

Subjects with no known Lyme Disease, past or present

Interventions

MicroB-plex Lyme Immunoassay

Subject's blood and clinical data are collected to develop a diagnostic immunoassay

Primary outcome measure

  • Percentage of EM positive patients who become MicroB-plex Lyme test positive prior to seroconversion [ Time Frame: Within 14 days of enrollment ]
  • Percentage of treated EM positive patients who become MicroB-plex Lyme test negative prior to their decline in serum [ Time Frame: Up to one year from enrollment ]

Central Contacts and Locations

Locations

Johns Hopkins University School of Medicine

Recruiting

Baltimore, Maryland, United States, 21205

Contacts

Paul Auwaerter, MD, MBA

443-287-4840Fishercenter@jhmi.edu

Principal Investigator:

Paul Auwaerter, M.B.A., M.D.

More Information

Sponsor

MicroB-plex, Inc.

Last update posted

Aug 13, 2019

Last verified

Aug, 2019

Keywords

  • Lyme Disease
  • Borrelia burgdorferi
  • Antibody Secreting Cells
  • Diagnostics
  • Early Diagnosis
  • Treatment Outcome
  • Health Volunteers
  • Adult

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-20. This information was provided to ClinicalTrials.gov by MicroB-plex, Inc. on 2019-08-13.