Lyme DiseaseNCT03963635
Novel Diagnostics for Early Lyme Disease
An observational study of Lyme Disease, run by MicroB-plex, Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Lyme Disease
- What is being tested?
- MicroB-plex Lyme Immunoassay
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2019to 31 Dec 2020
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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)
Who cannot join
- 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).
Show all 20Show fewer
- 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.)
- History of inflammatory bowel disease (Crohn's disease, Ulcerative colitis, etc.)
- History of HIV infection
- Received a Lyme disease vaccine in the past
- History of prior Lyme disease infection in the past
- Have any condition that, in the opinion of the principal investigator, would significantly increase the risk for the subject.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Johns Hopkins University School of Medicine
Baltimore, Maryland, 21205
Paul Auwaerter, MD, MBA, 443-287-4840, Fishercenter@jhmi.edu
Paul Auwaerter, M.B.A., M.D.
About this study
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.
Read the 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
- Being tested
- MicroB-plex Lyme Immunoassay
- Keywords
- Lyme Disease, Borrelia burgdorferi, Antibody Secreting Cells, Diagnostics, Early Diagnosis, Treatment Outcome, Health Volunteers, Adult
- Medical subject headings
- Lyme Disease, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MicroB-plex Lyme ImmunoassayDiagnostic test
Subject's blood and clinical data are collected to develop a diagnostic immunoassay
| Study group | Role | What they receive |
|---|---|---|
| Lyme Infected | Subjects presenting with suspected Lyme Disease Receives: Diagnostic Test: MicroB-plex Lyme Immunoassay | |
| Controls | Subjects with no known Lyme Disease, past or present Receives: Diagnostic Test: MicroB-plex Lyme Immunoassay |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: Up to one year from enrollment
Secondary outcomes (1)
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
Measured: Up to one year from enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2019
- Study start1 May 2019
- Primary completion31 Dec 2020 (estimated)
- Study completion31 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lyme DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- MicroB-plex, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Johns Hopkins University
- Responsible party
- Sponsor
- Investigators
- John L Daiss, PhD, Principal investigator, MicroB-plex, Inc.Frances E Lee, MD, Principal investigator, MicroB-plex, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03963635
- Sponsor's protocol ID
- 12251305
- Status last verified
- Aug 2019
- First submitted
- 23 May 2019
- Last updated
- 13 Aug 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Novel Diagnostics for Early Lyme Disease
- ClinicalTrials.gov ID
- NCT03963635
- Acronym / sponsor ID
- 12251305
- Conditions
- Lyme Disease
- Keywords
- Lyme Disease, Borrelia burgdorferi, Antibody Secreting Cells, Diagnostics, Early Diagnosis, Treatment Outcome, Health Volunteers, Adult
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- MicroB-plex, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Johns Hopkins University
- Study start
- 1 May 2019 (actual)
- Primary completion
- 31 Dec 2020 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 28 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lyme Infected | – | Diagnostic Test: MicroB-plex Lyme ImmunoassaySubjects presenting with suspected Lyme Disease |
| Controls | – | Diagnostic Test: MicroB-plex Lyme ImmunoassaySubjects with no known Lyme Disease, past or present |
Who may qualify
- Ages
- 21 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (20 listed)
- Have poor venous access.
- Have received any immunosuppressive therapy including biologics or recent course of steroids, or recent chemotherapy.
- On treatment for Lyme disease greater than seven days
- Recent chemotherapy
- History of solid organ transplant
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MicroB-plex Lyme ImmunoassaySubject's blood and clinical data are collected to develop a diagnostic immunoassay | Diagnostic test | Controls, Lyme Infected |
Primary outcome
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
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
1 secondary outcome
Percentage of treated EM positive patients who remain MicroB-plex Lyme test positive following treatment
Time frame: Up to one year from enrollment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Johns Hopkins University School of Medicine
Baltimore, United States
John L Daiss, PhD principal investigator
MicroB-plex, Inc.
Frances E Lee, MD principal investigator
MicroB-plex, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lyme Disease, run by MicroB-plex, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the 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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2019; AzTrials last refreshed its copy on 30 Oct 2026.