Protocol Number: 02-I-0055

Title:

Evaluation, Treatment and Follow up of Patients with Lyme Disease

Number:

02-I-0055

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.

Sponsoring Institute:

National Institute of Allergy and Infectious Diseases (NIAID)

Recruitment Detail

Type: Participants currently recruited/enrolled

Gender: Male & Female

Referral Letter Required: No

Population Exclusion(s): None

Eligibility Criteria:

INCLUSION CRITERIA:

Clinical diagnosis of active Lyme disease at the time of the initial NIH evaluation based on the CDC case definition.

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.

Unacceptable 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.

Special Instructions:

Currently Not Provided

Keywords:

Borrelia Burgdorferi

Lyme Disease

Infection

Therapy

Recruitment Keyword(s):

Lyme Disease

Lyme

Condition(s):

Lyme Disease

Investigational Drug(s):

None

Investigational Device(s):

None

Intervention(s):

None

Supporting Site:

National Institute of Allergy and Infectious Diseases

Contact(s):

Patient Recruitment and Public Liaison Office
Building 61
10 Cloister Court
Bethesda, Maryland 20892-4754
Toll Free: 1-800-411-1222
TTY: 301-594-9774 (local),1-866-411-1010 (toll free)
Fax: 301-480-9793

Electronic Mail:prpl@mail.cc.nih.gov

Citation(s):

Comparison of culture-confirmed erythema migrans caused by Borrelia burgdorferi sensu stricto in New York State and by Borrelia afzelii in Slovenia

The clinical spectrum of early Lyme borreliosis in patients with culture-confirmed erythema migrans

The early clinical manifestations of Lyme disease

• Questions about participating in a study, please contact the Patient Recruitment and Public Liaison Office, CC.
• Technical questions regarding the Clinical Center web site, please contact the Department of Networks and Applications, CC.

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National Institutes of Health Clinical Center Bethesda, Maryland 20892. Last update: 09/16/2008