Evaluation and treatment of patients with Lyme disease
Official title: Evaluation, Treatment, and Follow-up of Patients With Lyme Disease
Run by National Institutes of Health Clinical Center (CC) · NCT00028080 · Data updated 2026-11-12
This study is trying to understand and treat people with active Lyme disease by looking at their medical history, symptoms, and responses to approved medications.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 2 Years to 99 Years |
| Sex | All |
| Enrollment | 500 (estimated) |
| Sponsor | National Institutes of Health Clinical Center (CC) NIH |
| Locations | 1 site (Bethesda, Maryland) |
| Status | Recruiting |
| Started | January 16, 2002 |
| Registry record updated | November 9, 2026 |
| Trial ID | NCT00028080 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are individuals diagnosed with active Lyme disease based on CDC criteria.
✕Probably not a fit
Patients with post-treatment Lyme disease syndrome or those unable to comply with study requirements may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study aims to establish a defined population of patients with active Lyme disease for thorough evaluation, treatment, and follow-up. Participants will undergo medical history assessments, physical examinations, and various diagnostic evaluations, including laboratory tests and imaging studies, all adhering to standard medical practices. The study focuses on understanding the clinical course, biological markers, and immunological responses associated with Lyme disease. Treatment will involve FDA-approved medications administered according to established guidelines.
Why it matters
Potential benefit: If successful, this study could enhance understanding and management of Lyme disease, leading to improved patient outcomes.
How similar studies have gone: Other studies focusing on Lyme disease have shown promise in understanding its complexities, but this specific approach is part of ongoing efforts to rigorously define patient populations.
Who can join: the full rules
Show full inclusion / exclusion criteria
* INCLUSION CRITERIA: * Clinical diagnosis of active Lyme disease at the time of the initial NIH evaluation based on the CDC case definition. Study physician will review history to confirm probable cases. * Subjects must maintain a private physician for non-protocol related medical complaints and for emergency medical treatment required for these or other of their disorders. EXCLUSION CRITERIA: * Post treatment Lyme disease syndrome. * Unacceptably poor compliance, which, in the opinion of the investigator, would interfere with one's ability to study or provide quality medical care for the patient. ELIGIBILITY CRITERIA TO BE ASKED TO UNDERGO APHERESIS INCLUDE: * Age 18 years or above * Weight greater than 110 pounds * No known heart, lung, kidney disease, or bleeding disorders * Negative HIV, HCV and HBsAg serologies * Female subjects should not be pregnant or nursing * Adequate peripheral venous access Patients will have a CBC performed up to 2 weeks before the procedure. In order to be able to undergo the procedure, patient must fulfill all of the below: * Hemoglobin greater than 11 g/dL for males and greater than 10 g/dL for females * Platelets greater than 150 k/mm(3) * WBC greater than 3.5 x 10(3) uL * MCV above 80 Women who are able to conceive children must have a negative pregnancy test within 2 weeks before the procedure.
Where it's running
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National Institutes of Health Clinical Center
Bethesda, Maryland, United States Recruiting
Study contacts
- Principal investigator: Adriana R Marques, M.D. — National Institute of Allergy and Infectious Diseases (NIAID)
- Study coordinator: Ashley M Thomas
- Email: ashley.thomas2@nih.gov
- Phone: (240) 656-5458
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Fifth dose of the 6‑valent OspA Lyme vaccine (VLA15)
This test gives a fifth dose of the VLA15 Lyme vaccine to people age 7 and older who already got four doses to see if it is safe and boosts immune protection.
-
Exploring pregnancy and parenting experiences in individuals with Lyme disease
This study looks at how having Lyme disease affects pregnancy and parenting experiences for those diagnosed with the condition.
-
Assessing immune response in children with Lyme disease
This study is testing a new blood test to see how children's immune systems respond to Lyme disease to help doctors diagnose it earlier and better.
-
Assessing neurodevelopmental outcomes in infants exposed to Lyme disease during pregnancy
This study is trying to see how being exposed to Lyme disease during pregnancy affects the brain development of babies from birth to 18 months.
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Understanding how human skin reacts to tick bites
This study is testing how healthy adults' skin reacts to bites from certain ticks to better understand the immune response and help develop ways to resist tick bites.
-
Registry and biorepository for rheumatic diseases
This study is collecting samples and health information from adults with rheumatic diseases at Yale clinics to help researchers learn more about these conditions and improve future treatments.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.