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Novel Diagnostics for Early Lyme Disease

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ClinicalTrials.gov Identifier: NCT03963635
Recruitment Status : Recruiting
First Posted : May 28, 2019
Last Update Posted : August 13, 2019
Sponsor:
Collaborator:
Johns Hopkins University
Information provided by (Responsible Party):
MicroB-plex, Inc.

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.

Condition or disease Intervention/treatment
Lyme Disease Diagnostic Test: MicroB-plex Lyme Immunoassay

Detailed Description:
Lyme disease is the most commonly reported arthropod-borne infection in the US with recent CDC estimates eclipsing 300,000 new cases in 2013. In addition to growing in frequency, the infections have a complex and increasingly severe course. Beginning with mild flu-like symptoms and frequently a signature bull's-eye rash, erythema migrans, Lyme disease can progress to severe articular, neurological and cardiac symptoms, most of which are preventable with early antibiotic therapy. Leading investigators have identified two major shortcomings to the current serology-based methods for the definitive diagnosis of Early Localized Lyme disease. First, the clinical sensitivity in the first four weeks is poor, under 50% at the time of symptom onset, so many patients remain undiagnosed or unconfirmed until the disease has had time to progress. Second, serum antibody levels remain elevated long after the infection has been resolved making the monitoring of therapeutic success or diagnosis of re-infection virtually impossible. MicroB-plex will address these shortcomings by using a novel sample matrix from circulating antibody secreting cells (ASC) for diagnosis of Lyme disease. This novel matrix is MENSA (medium enriched for newly synthesized antibody). In this study, MicroB-plex and its clinical collaborators will test whether MENSA is effective in early Lyme diagnostic (within the first 2 weeks) and if this new approach will track therapeutic success.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 100 participants
Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration: 1 Year
Official Title: Novel Diagnostics for Early Lyme Disease
Actual Study Start Date : May 1, 2019
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lyme Disease

Group/Cohort Intervention/treatment
Lyme Infected
Subjects presenting with suspected Lyme Disease
Diagnostic Test: MicroB-plex Lyme Immunoassay
Subject's blood and clinical data are collected to develop a diagnostic immunoassay

Controls
Subjects with no known Lyme Disease, past or present
Diagnostic Test: MicroB-plex Lyme Immunoassay
Subject's blood and clinical data are collected to develop a diagnostic immunoassay




Primary Outcome Measures :
  1. Percentage of EM positive patients who become MicroB-plex Lyme test positive prior to seroconversion [ Time Frame: Within 14 days of enrollment ]
    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

  2. 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 ]
    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


Secondary Outcome Measures :
  1. Percentage of treated EM positive patients who remain MicroB-plex Lyme test positive following treatment [ Time Frame: Up to one year from enrollment ]
    MicroB-plex Lyme Test, that measures anti-Lyme antibodies in MENSA, remains positive with treatment failure


Biospecimen Retention:   Samples With DNA
Anti-coagulated whole blood, Serum, Peripheral Blood Mononuclear Cells


Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03963635


Locations
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United States, Maryland
Johns Hopkins University School of Medicine Recruiting
Baltimore, Maryland, United States, 21205
Contact: Paul Auwaerter, MD, MBA    443-287-4840    Fishercenter@jhmi.edu   
Principal Investigator: Paul Auwaerter, M.B.A., M.D.         
Sponsors and Collaborators
MicroB-plex, Inc.
Johns Hopkins University
Investigators
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Principal Investigator: John L Daiss, PhD MicroB-plex, Inc.
Principal Investigator: Frances E Lee, MD MicroB-plex, Inc.
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Responsible Party: MicroB-plex, Inc.
ClinicalTrials.gov Identifier: NCT03963635    
Other Study ID Numbers: 12251305
First Posted: May 28, 2019    Key Record Dates
Last Update Posted: August 13, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by MicroB-plex, Inc.:
Lyme Disease
Borrelia burgdorferi
Antibody Secreting Cells
Diagnostics
Early Diagnosis
Treatment Outcome
Health Volunteers
Adult
Additional relevant MeSH terms:
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Lyme Disease
Borrelia Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Tick-Borne Diseases
Spirochaetales Infections