Novel Diagnostics for Early Lyme Disease

NCT03963635 | Unknown

• 1 other identifier: 12251305
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Percentage of EM positive patients who become MicroB-plex Lyme test positive prior to seroconversion

  MicroB-plex Lyme Test, that measures anti-Lyme antibodies in MENSA, becomes positive prior to conventional Lyme immunoassays that measure antibodies in serum, resulting in earlier diagnosis

  Within 14 days of enrollment

• Percentage of treated EM positive patients who become MicroB-plex Lyme test negative prior to their decline in serum

  MicroB-plex Lyme Test, that measures anti-Lyme antibodies in MENSA, becomes negative with successful treatment, prior to a decline in serum antibody level in conventional immunoassays, providing an earlier measure of effective therapy

  Up to one year from enrollment

Secondary Outcomes (1)

• Percentage of treated EM positive patients who remain MicroB-plex Lyme test positive following treatment

  Up to one year from enrollment

Study Arms (2)

Lyme Infected

Subjects presenting with suspected Lyme Disease

Diagnostic Test: MicroB-plex Lyme Immunoassay

Controls

Subjects with no known Lyme Disease, past or present

Diagnostic Test: MicroB-plex Lyme Immunoassay

Interventions

MicroB-plex Lyme Immunoassay DIAGNOSTIC_TEST

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

Controls; Lyme Infected

Eligibility Criteria

• Age: 21 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult humans with a strong clinical suspicion of acute Lyme disease, with symptoms seven days or less. Subjects will be recruited from medical centers residing in Maryland.

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.)

Sponsors & Collaborators

• MicroB-plex, Inc.: lead
• Johns Hopkins University: collaborator

Study Sites (1)

Johns Hopkins University School of Medicine

Baltimore, Maryland, 21205, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Anti-coagulated whole blood, Serum, Peripheral Blood Mononuclear Cells

MeSH Terms

Conditions

Lyme Disease; Disease

Condition Hierarchy (Ancestors)

Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Borrelia Infections; Spirochaetales Infections; Tick-Borne Diseases; Vector Borne Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• John L Daiss, PhD

  MicroB-plex, Inc.

  PRINCIPAL INVESTIGATOR

• Frances E Lee, MD

  MicroB-plex, Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 23, 2019
• First Posted: May 28, 2019
• Study Start: May 1, 2019
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2020
• Last Updated: August 13, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)