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Observational Study of Lyme Disease

This study aims to understand Lyme disease better by observing a group of patients. It's not testing a new drug, but rather gathering information about how Lyme disease affects people, how it's treated, and how patients recover over time. You may be able to join if you have an active diagnosis of Lyme disease based on CDC guidelines. The study hopes to create a clear group of Lyme disease patients to help future research. The current status of this study is unclear.

Study design
This is an observational study, meaning researchers will watch and collect information from up to 500 participants. It is not testing a specific intervention.
What's involved
You will have a medical history review, physical exam, and various diagnostic tests like blood and urine tests, X-rays, or other imaging. Treatment will involve FDA-approved medications given according to standard practices.
Compensation
Not stated in the trial record.
Follow-up
The study plans to follow participants to gather information until at least December 31, 2030.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT00028080

Evaluation, Treatment, and Follow-up of Patients With Lyme Disease

Recruiting
Not specifiedAges 2–99Observational
National Institute of Allergy and Infectious Diseases (NIAID)
~500 participants
Updated 2026-08-07 on ClinicalTrials.gov

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Develop a defined population of patients with Lyme disease to serve as the basis of research in multiple aspects of the infection.
Measured over 12/31/2030

Conditions

Lyme Disease

Explore related trials

Borrelia Burgdorferi Infection

NCT00028080

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • National Institutes of Health Clinical Center

    Bethesda, Marylandstudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Adriana R Marques, M.D. · PRINCIPAL_INVESTIGATOR · National Institute of Allergy and Infectious Diseases (NIAID)

Who to contact

Ashley M Thomas
[email protected]
(240) 656-5458
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

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Eligibility criteria

Inclusion

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

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.
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
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

What this trial measures

  • Develop a defined population of patients with Lyme disease to serve as the basis of research in multiple aspects of the infection.12/31/2030

    Explore the biological markers of Borrelia infections, assessment of clinical course and outcomes of patients with Lyme infection, and the immunological response to B. burgdorferi infection.