Lyme Disease Clinical Trial
Official title:
Novel Diagnostics for Early Lyme Disease
NCT number | NCT03963635 |
Other study ID # | 12251305 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | May 1, 2019 |
Est. completion date | December 31, 2020 |
Verified date | August 2019 |
Source | MicroB-plex, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational [Patient Registry] |
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.
Status | Recruiting |
Enrollment | 100 |
Est. completion date | December 31, 2020 |
Est. primary completion date | December 31, 2020 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 21 Years to 80 Years |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
United States | Johns Hopkins University School of Medicine | Baltimore | Maryland |
Lead Sponsor | Collaborator |
---|---|
MicroB-plex, Inc. | Johns Hopkins University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | Percentage of treated EM positive patients who remain MicroB-plex Lyme test positive following treatment | MicroB-plex Lyme Test, that measures anti-Lyme antibodies in MENSA, remains positive with treatment failure | Up to one year from enrollment |
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