- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00028080
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.
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Adriana R Marques, M.D.
- Phone Number: (301) 435-7244
- Email: amarques@niaid.nih.gov
Study Contact Backup
- Name: Sheena Jose
- Phone Number: (301) 402-7635
- Email: lymedxstudies@niaid.nih.gov
Study Locations
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Maryland
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Bethesda, Maryland, United States, 20892
- Recruiting
- National Institutes of Health Clinical Center
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Contact:
- For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR)
- Phone Number: TTY dial 711 800-411-1222
- Email: ccopr@nih.gov
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
- 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.
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
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Lyme Disease
Participants who have been diagnosed with or are strongly suspected to have Lyme disease.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Develop a defined population of patients with Lyme disease to serve as the basis of research in multiple aspects of the infection.
Time Frame: 12/31/2030
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Explore 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.
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12/31/2030
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Collaborators and Investigators
Investigators
- Principal Investigator: Adriana R Marques, M.D., National Institute of Allergy and Infectious Diseases (NIAID)
Publications and helpful links
General Publications
- Marques AR. Lyme Neuroborreliosis. Continuum (Minneap Minn). 2015 Dec;21(6 Neuroinfectious Disease):1729-44. doi: 10.1212/CON.0000000000000252.
- Wills AB, Spaulding AB, Adjemian J, Prevots DR, Turk SP, Williams C, Marques A. Long-term Follow-up of Patients With Lyme Disease: Longitudinal Analysis of Clinical and Quality-of-life Measures. Clin Infect Dis. 2016 Jun 15;62(12):1546-1551. doi: 10.1093/cid/ciw189. Epub 2016 Mar 29.
- Marques AR. Laboratory diagnosis of Lyme disease: advances and challenges. Infect Dis Clin North Am. 2015 Jun;29(2):295-307. doi: 10.1016/j.idc.2015.02.005.
- Gwynne PJ, Clendenen LH, Turk SP, Marques AR, Hu LT. Antiphospholipid autoantibodies in Lyme disease arise after scavenging of host phospholipids by Borrelia burgdorferi. J Clin Invest. 2022 Mar 15;132(6):e152506. doi: 10.1172/JCI152506.
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 020055
- 02-I-0055
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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