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Sponsored by: |
National Institute of Allergy and Infectious Diseases (NIAID) |
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Information provided by: | National Institutes of Health Clinical Center (CC) |
ClinicalTrials.gov Identifier: | NCT00028080 |
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:
Condition |
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Lyme Disease |
Study Type: | Observational |
Official Title: | Evaluation, Treatment and Follow up of Patients With Lyme Disease |
Estimated Enrollment: | 200 |
Study Start Date: | November 2001 |
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.
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
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.
Contact: Patient Recruitment and Public Liaison Office | (800) 411-1222 | prpl@mail.cc.nih.gov |
Contact: TTY | 1-866-411-1010 |
United States, Maryland | |
National Institutes of Health Clinical Center, 9000 Rockville Pike | Recruiting |
Bethesda, Maryland, United States, 20892 |
Study ID Numbers: | 020055, 02-I-0055 |
Study First Received: | December 11, 2001 |
Last Updated: | October 16, 2008 |
ClinicalTrials.gov Identifier: | NCT00028080 |
Health Authority: | United States: Federal Government |
Borrelia Burgdorferi Lyme Disease Infection |
Therapy Lyme Disease Lyme |
Bacterial Infections Borrelia Infections Borreliosis |
Lyme Disease Tick-Borne Diseases Gram-Negative Bacterial Infections |
Spirochaetales Infections |