Clinical Trial Finder

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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Observational
Eligible Ages 2 Years - 99 Years
Gender All
More 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 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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT00028080
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 National Institute of Allergy and Infectious Diseases (NIAID)
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 Adriana R Marques, M.D.
Principal Investigator Affiliation National Institute of Allergy and Infectious Diseases (NIAID)
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 NIH
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Lyme Disease
Study Website: View Trial Website
Additional Details

Lyme disease is a multisystem illness caused by the spirochete Borrelia burgdorferi and it is the most common vector-borne illness in the United States. This protocol is designed to offer evaluation, therapy and follow up to patients with Lyme disease. This is a natural history study, which has the objective of developing a rigorously defined population of patients with Lyme disease to serve as the basis of research in multiple aspects of the infection. These research sub-projects have emphasis in exploring 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.

Arms & Interventions

Arms

: Lyme Disease

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

Interventions

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Bethesda, Maryland

Status

Recruiting

Address

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892

Site Contact

For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR)

[email protected]

800-411-1222 #TTY dial 711

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