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Early Lyme Disease Study

Protocol Number: IRB00163923
Principal Investigator: Paul Auwaerter, MD, MBA
Johns Hopkins University, School of Medicine

Research Study: Novel Diagnostics for Early Lyme Disease
Johns Hopkins Clinical Research Study

(443) 287-4840

Email: fishercenter@jhmi.edu

Study Description

This research is being done to investigate a new diagnostic test for early Lyme disease and treatment follow up.
We are only recruiting people with early Lyme disease – with no more than 7 days of current symptoms.

This study will evaluate a new blood test for early Lyme disease based on cells the body makes before antibodies are detectable in the blood. This test may also measure the effectiveness of antibiotics used to treat Lyme disease.

We are Recruiting

  • Adults 21 years to 80 years
  • Must be willing to return to our clinic in Lutherville, Maryland for up to nine study visits and blood draws, over a one year period
  • Recent (7 days or less) diagnosis or strong suspicion of Lyme disease
  • Must have rash associated with Lyme disease (erythema migrans)

The rash is red or bluish purple in hue and may be solid or have central clearing. It may appear on any part of the body

 

 

 

 

Circular red rash with a central clearing

 

 

 

 

 

Red, expanding lesion with central crust

Photo source: CDC and Auwaerter

You will be paid a $25 gift card for each study visit.

Exclusions

Unfortunately, for this particular study we cannot enroll participants with the following medication conditions:

  • A diagnosis of Lyme disease greater than seven (7) days
  • On treatment for Lyme disease greater than seven (7) days
  • Recent chemotherapy
  • Solid organ transplant
  • On immunosuppressive medications
  • Autoimmune disorders (SLE, Rheumatoid arthritis, Scleroderma, etc.)
  • Inflammatory muscle disease (polymyositis, dermatomyositis, etc.)
  • Inflammatory bowel disease (Crohn’s disease, Ulcerative colitis)
  • HIV
  • Received a Lyme vaccine in the past
  • Had Lyme disease in the past

Controls

We are also recruiting Controls, people who have never had Lyme disease or a Lyme disease vaccine, but want to participate. Controls have a one-time visit for a blood draw.

Study Location

Study visits will take place at Johns Hopkins | Green Spring Station
10751 Falls Rd., Suite 412
Lutherville, MD 21093

Contact Information

If interested, call 443-287-4840
Email: fishercenter@jhmi.edu

Study Approval Information

This study was approved by the Johns Hopkins Medicine, Institutional Review Board (IRB).
Johns Hopkins IRB Number: IRB00163923
Principal Investigator: Paul Auwaerter, MD, MBA
Johns Hopkins University, School of Medicine

About Lyme Disease

 

Lyme disease is a bacterial infection transmitted to humans by the bite of an infected blacklegged (deer) tick.

 

Symptoms vary from person to person, but often include:

  • Fatigue
  • Headache
  • Fever and/or chills
  • Muscle and/or joint aches
  • Joint Swelling
  • Rash

If untreated, the symptoms may progress or become more severe.

Diagnosis is by blood tests for Lyme disease antibodies, chemicals the body develops in response to an infection.  Antibodies may take 2-4 weeks to develop after a tick bite, which may cause a delay in diagnosis and treatment.  Also, it is impossible to monitor treatment effectiveness with current antibody tests.