Evaluation and treatment of patients with Lyme disease

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

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
• Enrollment: 500 (estimated)
• Ages: 2 Years to 99 Years
• Sex: All
• Sponsor: National Institutes of Health Clinical Center (CC) (NIH)
• Locations: 1 site (Bethesda, Maryland)
• Trial ID: NCT00028080 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are individuals diagnosed with active Lyme disease based on CDC criteria.

Not a fit: Patients with post-treatment Lyme disease syndrome or those unable to comply with study requirements may not benefit from this study.

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 performed: 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.

Eligibility 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 UNDERGO APHERESIS:

* 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.
* 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 this trial is running

Bethesda, Maryland

• 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

Conditions Lyme Disease; Borrelia Burgdorferi; Infection; Therapy; Natural History; Lyme