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Evaluation, Treatment, and Follow-up of Patients With Lyme Disease

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ClinicalTrials.gov Identifier: NCT00028080
Recruitment Status : Recruiting
First Posted : December 12, 2001
Last Update Posted : October 14, 2019
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute of Allergy and Infectious Diseases (NIAID) )

Tracking Information
First Submitted Date December 11, 2001
First Posted Date December 12, 2001
Last Update Posted Date October 14, 2019
Actual Study Start Date January 16, 2002
Primary Completion Date Not Provided
Current Primary Outcome Measures
 (submitted: September 26, 2019)
Develop a defined population of patients with Lyme disease to serve as the basis of research in multiple aspects of the infection. [ Time Frame: 12/31/30 ]
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.
Original Primary Outcome Measures Not Provided
Change History Complete list of historical versions of study NCT00028080 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Evaluation, Treatment, and Follow-up of Patients With Lyme Disease
Official Title Evaluation, Treatment and Follow up of Patients With Lyme Disease
Brief 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.
Detailed Description 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.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population primary clinical
Condition Lyme Disease
Intervention Not Provided
Study Groups/Cohorts Lyme Disease
Participants who have been diagnosed with or are strongly suspected to have Lyme disease.
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: September 26, 2019)
500
Original Enrollment
 (submitted: June 23, 2005)
100
Study Completion Date Not Provided
Primary Completion Date Not Provided
Eligibility Criteria
  • 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.

Sex/Gender
Sexes Eligible for Study: All
Ages 2 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Siu-Ping Turk, R.N. (301) 451-7661 lymedxstudies@niaid.nih.gov
Contact: Adriana R Marques, M.D. (301) 435-7244 amarques@niaid.nih.gov
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT00028080
Other Study ID Numbers 020055
02-I-0055
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party National Institutes of Health Clinical Center (CC) ( National Institute of Allergy and Infectious Diseases (NIAID) )
Study Sponsor National Institute of Allergy and Infectious Diseases (NIAID)
Collaborators Not Provided
Investigators
Principal Investigator: Adriana R Marques, M.D. National Institute of Allergy and Infectious Diseases (NIAID)
PRS Account National Institutes of Health Clinical Center (CC)
Verification Date October 10, 2019