Novel Diagnostics for Early Lyme Disease

NCT ID: NCT03963635

Last Updated: 2019-08-13

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-05-01
• Study Completion Date: 2020-12-31

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.

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.

Conditions

Lyme Disease

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Lyme Infected

Subjects presenting with suspected Lyme Disease

MicroB-plex Lyme Immunoassay

Intervention Type: DIAGNOSTIC_TEST

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

Controls

Subjects with no known Lyme Disease, past or present

MicroB-plex Lyme Immunoassay

Intervention Type: DIAGNOSTIC_TEST

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

Interventions

MicroB-plex Lyme Immunoassay

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

Intervention Type: DIAGNOSTIC_TEST

Eligibility 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.

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Johns Hopkins University

OTHER

Sponsor Role: collaborator

MicroB-plex, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

John L Daiss, PhD

Role: PRINCIPAL_INVESTIGATOR

MicroB-plex, Inc.

Frances E Lee, MD

Role: PRINCIPAL_INVESTIGATOR

MicroB-plex, Inc.

Locations

Johns Hopkins University School of Medicine

Baltimore, Maryland, United States

Site Status: RECRUITING

Countries

United States

Facility Contacts

Paul Auwaerter, MD, MBA

Role: primary

Fishercenter@jhmi.edu

443-287-4840

Other Identifiers

12251305

Identifier Type: -

Identifier Source: org_study_id