A Comprehensive Clinical, Microbiological and Immunological Assessment of Patients With Suspected Post Treatment Lyme Disease Syndrome and Selected Control Populations
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|ClinicalTrials.gov Identifier: NCT00001539|
Recruitment Status : Recruiting
First Posted : November 4, 1999
Last Update Posted : April 12, 2021
This study will determine whether patients who have been infected with the Lyme bacteria, Borrelia burgdorferi, and treated with antibiotics still have the bacteria alive inside them and whether it is causing their symptoms. The information from this study may serve as a basis for developing stringent diagnostic criteria for Lyme disease and the establishment of future treatment trials.
Individuals in the following categories may be eligible for this study: chronic Lyme disease; chronic Lyme arthritis; seropositive control (are infected with the bacteria that causes Lyme disease but do not have disease symptoms); recovered control (have been sick with Lyme disease but were treated successfully and are currently well); control with multiple sclerosis (patients with multiple sclerosis); and healthy volunteers. Patients in the chronic Lyme disease category must be age 13 and above; all others must be age18 and above. Candidates will be screened with blood and urine tests.
Participants will have a physical examination and the following tests:
Blood tests Includes HLA-typing, a genetic test of immune system markers;
Leukapheresis Collection of large numbers of white blood cells Whole blood is collected through a needle in an arm vein. The blood circulates through a machine that separates it into its components. The white cells are removed and the rest of the blood is returned to the body, either through the same needle used to draw the blood or through another needle in the other arm. (Alternatively, patients will 100 cc (about 7 tablespoons) of blood drawn.);
Lumbar puncture (spinal tap) Collection of cerebrospinal fluid (CSF, fluid that bathes the brain and spinal cord). A local anesthetic is administered and a needle is inserted in the space between the bones in the lower back where the cerebrospinal fluid circulates below the spinal cord. A small amount of fluid is collected through the needle;
Magnetic resonance imaging (MRI) of the brain Imaging of the brain using a strong magnetic field and radio waves instead of X-rays. During the scan, the patient lies on a table in a narrow cylinder containing a magnetic field. He or she can speak with a staff member via an intercom at all times during the procedure;
Some participants may also have a hearing test and urine collection.
Participants whose test results are positive for Borrelia burgdorferi will be followed at NIH at intervals of 3 to 6 months until it is determined whether there is infection. Those who are infected will be offered treatment with the antibiotic ceftriaxone. Following treatment, patients will return to the NIH Clinical Center for follow-up visits 1 week after treatment and again at 3, 6 and 12 months. The lumbar puncture, hearing examination, blood and urine tests will be repeated at these visits to evaluate the response to treatment, and the leukapheresis will be repeated for research purposes. Patients whose MRI was abnormal during therapy will have a repeat MRI at the 3-month, 6-month and 1-year visits.
All participants with chronic Lyme disease, chronic Lyme arthritis, seropositive controls and recovered controls may be reevaluated at intervals of 6 to 12 months.
|Condition or disease|
|Study Type :||Observational|
|Estimated Enrollment :||600 participants|
|Official Title:||A Comprehensive Clinical, Microbiological and Immunological Assessment of Patients With Suspected Post Treatment Lyme Disease Syndrome and Selected Control Populations|
|Actual Study Start Date :||July 2, 1996|
healthy individuals who have never had Lyme disease
patients with suspected Lyme arthritis
Multiple sclerosis controls
patients diagnosed with multiple sclerosis who have never been diagnosed with Lyme disease
patients who received two doses of the OspA vaccine
patients with presumed PTLDS
PTLDS for screening
patients suspected of PTLDS for screening
patients who were diagnosed with Lyme disease, treated, and fully recovered
patients who are seropositive for Lyme disease, but have no manifestations/symptoms and have never been treated for Lyme disease
- Assemble and follow a well-characterized cohort of patients with post-treatment Lyme disease syndrome and relevant controls [ Time Frame: duration of the study ]This protocol serves as the basis for multiple parallel lines of investigation in different aspects of Lyme disease and PTLDS. The formation of the cohort and follow up are the main outcomes.
- Explore biological markers of B. burgdorferi infection and PTLDS [ Time Frame: duration of the study ]Explore biological markers of B. burgdorferi infection and PTLDS
- Assessment of clinical course and outcomes of patients with PTLDS [ Time Frame: duration of the study ]Assessment of clinical course and outcomes of patients with PTLDS
- Assessment of the immunological response in patients with PTLDS [ Time Frame: duration of the study ]Assessment of the immunological response in patients with PTLDS
- Development of new tests for Lyme disease and PTLDS [ Time Frame: duration of the study ]Development of new tests for Lyme disease and PTLDS
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00001539
|Contact: Siu-Ping Turk, R.N.||(301) firstname.lastname@example.org|
|Contact: Adriana R Marques, M.D.||(301) email@example.com|
|United States, Maryland|
|National Institutes of Health Clinical Center, 9000 Rockville Pike||Recruiting|
|Bethesda, Maryland, United States, 20892|
|Contact: For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR) 800-411-1222 ext TTY8664111010 firstname.lastname@example.org|
|Principal Investigator:||Adriana R Marques, M.D.||National Institute of Allergy and Infectious Diseases (NIAID)|