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A Comprehensive Clinical, Microbiological and Immunological Assessment of Patients With Suspected Post Treatment Lyme Disease Syndrome and Selected Control Populations

StatusRecruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗

Amendment history

The 50 most recent of 380 record versions are accounted for below. See every version on ClinicalTrials.gov ↗

  1. Minor

    Enrollment increased: 700 → 800 participants

    Eligibility criteria expanded, about 44 words

    Show what changed: Eligibility criteria
    [...] tudy team in both an identifiable and unidentifiable manner. The NIH investigator will provide and request that the NIH staff member review the Frequently Asked Questions (FAQs) for Staff Who are Considering Participation in NIH Research and the Leave Policy for NIH Employees Participating in NIH Medical Research Studies (NIH Policy Manual 2300-630-3).

  2. Minor

    Enrollment target: 700 to 800

  3. Minor

    Eligibility criteria expanded, about 35 words

    Publications: details revised at 2 of 2 entries

    Show what changed: Eligibility criteria
    * INCLUSION CRITERIA: SCREENING FOR SUSPECTED PTLDS Age \>= 13 years old, suspect of suffering from Lyme disease POST [...] symptoms and/or signs for at least six months after therapy \[4, 5\]. (5) They also should have no other documented explanation [...] had received accepted antibiotic treatment for Lyme disease \[5\] (at least 3 months since the end of antibiotic therapy bef [...] burgdorferi by the CDC criteria. GENERAL EXCLUSION CRITERIA 1. Age less than 18 (less than 13 for patients with PTLDS) 2. Weight less than 70 Lb. (35 kg) 3. Pregnancy or lactation 4. Women with childbearing potential who are sexuall [...] [...]

  4. Minor

    47 amendments

    47 re-verifications since 2024-12-18, no change to tracked fields

    v331-v377

  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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; Neuropsychologic testing; 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.
Trial Details
NCT Number NCT00001539
Lead Sponsor National Institute of Allergy and Infectious Diseases (NIAID)
Conditions Lyme Disease
Enrollment 800 participants
Start Date
Updated on ClinicalTrials.gov