Evaluation, Treatment, and Follow-up of Patients With Lyme Disease
| Status: | Recruiting |
|---|---|
| Conditions: | Infectious Disease |
| Therapuetic Areas: | Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 1/31/2019 |
| Start Date: | November 21, 2001 |
| Contact: | Adriana R Marques, M.D. |
| Email: | lymedxstudies@niaid.nih.gov |
| Phone: | (301) 435-7244 |
Evaluation, Treatment and Follow up of Patients With Lyme Disease
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.
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.
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.
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.
- 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.
We found this trial at
1
site
9000 Rockville Pike
Bethesda, Maryland 20892
Bethesda, Maryland 20892
Phone: 800-411-1222
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