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

NCT00028080 | Recruiting

• 2 other identifiers: 02005502-I-0055
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

Brief Summary

This study is designed to establish a population of patients with Lyme disease for evaluation, treatment and follow-up to learn more about the infection. Patients with active Lyme disease may be eligible for this study. Participants will have a medical history and physical examination and diagnostic evaluations as appropriate to their individual condition. Laboratory tests may include routing blood and urine tests, X-rays, or other imaging studies, body fluid or tissue cultures, skin biopsy and tests for allergic or immune responses. Treatment will include only medications approved by the Food and Drug Administration, given according to accepted dose schedules and ways of taking the medicines. All diagnostic tests and treatments will be according to standard medical practice for the disease. No experimental procedures will be offered under this protocol. Patients will be followed as needed for evaluation and treatment of their condition. In general, they will be asked to return at the end of therapy, then 3, 6 and 12 months later, and then every 6 to 12 months. More frequent visits may be required or less frequent visits may be allowed, depending on the individual s condition. Participants may be asked to undergo the following additional procedures for research purposes:

• Extra blood draws to study Lyme disease and other inflammatory conditions. Blood will be drawn from arm veins. The total amount drawn during any 6-week period will not exceed 450 cc (30 tablespoons) for adults and 7 cc (1/2 tablespoon) per kilogram (2.2 pounds) of body weight for children under 18 years of age.
• Leukapheresis to collect large numbers of white blood cells. Whole blood is collected through a needle in an arm vein, similar to donating blood. The blood circulates through a machine that separates it into its components, and the white cells are removed. The rest of the blood is returned to the body through the same needle. Only adults 18 years of age and older will be asked to undergo leukapheresis.

Conditions

Lyme Disease

Keywords

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

Outcome Measures

Primary Outcomes (1)

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

  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.

  12/31/2030

Study Arms (1)

Lyme Disease

Participants who have been diagnosed with or are strongly suspected to have Lyme disease.

Eligibility Criteria

• Age: 2 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

primary clinical

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead

Study Sites (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

RECRUITING

Related Publications (4)

• Marques AR. Lyme Neuroborreliosis. Continuum (Minneap Minn). 2015 Dec;21(6 Neuroinfectious Disease):1729-44. doi: 10.1212/CON.0000000000000252.

  PMID: 26633786 BACKGROUND

• Wills AB, Spaulding AB, Adjemian J, Prevots DR, Turk SP, Williams C, Marques A. Long-term Follow-up of Patients With Lyme Disease: Longitudinal Analysis of Clinical and Quality-of-life Measures. Clin Infect Dis. 2016 Jun 15;62(12):1546-1551. doi: 10.1093/cid/ciw189. Epub 2016 Mar 29.

  PMID: 27025825 BACKGROUND

• Marques AR. Laboratory diagnosis of Lyme disease: advances and challenges. Infect Dis Clin North Am. 2015 Jun;29(2):295-307. doi: 10.1016/j.idc.2015.02.005.

  PMID: 25999225 BACKGROUND

• Gwynne PJ, Clendenen LH, Turk SP, Marques AR, Hu LT. Antiphospholipid autoantibodies in Lyme disease arise after scavenging of host phospholipids by Borrelia burgdorferi. J Clin Invest. 2022 Mar 15;132(6):e152506. doi: 10.1172/JCI152506.

  PMID: 35289310 DERIVED

Related Links

• NIH Clinical Center Detailed Web Page

MeSH Terms

Conditions

Lyme Disease; Infections

Condition Hierarchy (Ancestors)

Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Borrelia Infections; Spirochaetales Infections; Tick-Borne Diseases; Vector Borne Diseases

Study Officials

• Adriana R Marques, M.D.

  National Institute of Allergy and Infectious Diseases (NIAID)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ashley M Thomas

CONTACT

(240) 656-5458; ashley.thomas2@nih.gov

Adriana R Marques, M.D.

CONTACT

(301) 435-7244; amarques@niaid.nih.gov

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 11, 2001
• First Posted: December 12, 2001
• Study Start: January 16, 2002
• Last Updated: March 18, 2026

Record last verified: 2026-03-13

Locations

US (1)