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

  • STATUS
    Recruiting
  • participants needed
    700
  • sponsor
    National Institute of Allergy and Infectious Diseases (NIAID)
Updated on 21 September 2022
antibiotic therapy
antibiotics
ceftriaxone
spinal cord
arthritis
genetic test
enzyme-linked immunosorbent assay
antibody test
chronic lyme disease
post-treatment lyme disease syndrome
ospa vaccine
Accepts healthy volunteers

Summary

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.

Description

Lyme disease has emerged as the leading vector-borne disease in the United States. Despite how much has been learned about Lyme borreliosis in the past decade, there are still many remaining areas of uncertainty. One fundamental question is whether persistent signs and symptoms of disease, despite the administration of what is currently considered to be adequate antibiotic therapy, are due to ongoing active borrelial infection, to a post-infectious syndrome, to irreversible sequelae of earlier tissue injury or due to a condition unrelated to Lyme disease. Reliable objective markers of infection, of clinical status and of host responses to the organism are required to discern the scope and the implications of persistent borrelial infection, the effectiveness of current treatment options, and the development of new therapeutic approaches. The goal of this study is to assemble and follow a well-characterized cohort of patients with post-treatment Lyme disease syndrome and relevant controls that will yield a prospective database upon which stringent diagnostic criteria can be established and future therapeutic trials can be designed.

Details
Condition Lyme Disease
Clinical Study IdentifierNCT00001539
SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
Last Modified on21 September 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

SCREENING FOR SUSPECTED PTLDS
Age >= 13 years old, suspect of suffering from Lyme disease
disease
POST-TREATMENT LYME DISEASE SYNDROME (PTLDS)
For the purposes of this study, PTLDS is defined as (1) occurring in male or female
patients aged 13 and above (2) who have been diagnosed with confirmed or probable Lyme
disease per CDC definition
(<https://wwwn.cdc.gov/nndss/conditions/lyme-disease/case-definition/2017/>). Study physician
will review history to confirm probable cases. (3) They have received recommended
antibiotic therapy (4) and have persistent or relapsing symptoms and/or signs for at least
six months after therapy [4, 5]. (5) They also should have no other documented explanation
for their signs and symptoms
LYME ARTHRITIS CONTROLS
For the purposes of this study, Lyme arthritis is defined as occurring in an otherwise
healthy male or female aged 18 and above who have intermittent episodes of arthritis
involving one or few joints, without any other cause being documented, and have positive
serum antibodies to B. burgdorferi confirmed by IgG Western blot according to the CDC
criteria
RECOVERED CONTROLS
For the purposes of this study, a recovered control is defined as an otherwise healthy male
or female aged 18 and above who has had confirmed or probable Lyme disease, fulfilling the
CDC Lyme Disease National Surveillance Case Definition (appendix 5), and who had received
accepted antibiotic treatment for Lyme disease [5] (at least 3 months since the end of
antibiotic therapy before protocol evaluation) and who are currently asymptomatic
SEROPOSITIVE CONTROLS
recall no episodes of disease compatible with Lyme infection and have not received
For the purposes of this study, a seropositive control is defined as an otherwise healthy
male or female aged 18 and above who has positive serum IgG antibody response to B
burgdorferi by Western blot according to the CDC criteria and are asymptomatic and who
antibiotic therapy for Lyme
OSPA VACCINATED CONTROL
For the purposes of this study, an OspA vaccinated control is defined as an otherwise
healthy male or female age 18 and above who has received at least two doses of the OspA
vaccine for Lyme disease (Lymerix ). These controls may have a positive ELISA for B
burgdorferi but a negative (or unreadable) IgG western blot
MULTIPLE SCLEROSIS CONTROLS
For the purposes of this study, a multiple sclerosis control is defined as an otherwise
healthy male or female aged 18 and above with relapsing-remitting or progressive multiple
sclerosis as defined by the Clinical Trial Committee of the National Multiple Sclerosis
Society and no evidence of prior exposure to B. burgdorferi as indicate by negative history
for Lyme disease and negative western blot for B. burgdorferi in the serum by the CDC
criteria. Patients should have a Kurtzke or Expanded Disability Status Scale (EDSS) between
and 5
HEALTHY VOLUNTEERS
For the purpose of this study, a healthy volunteer is defined as healthy male or female
age 18 and above, with no history compatible with Lyme disease and negative serological
testing to B. burgdorferi by the CDC criteria

Exclusion Criteria

Age less than 18 (less than 13 for patients with PTLDS)
Weight less than 70 Lb. (35 kg)
Pregnancy or lactation
Not able to understand all of the requirements of the study or unable to give informed
Women with childbearing potential who are sexually active with a male partner and
consent and/or comply with all aspects of the evaluation
unwilling to use effective contraception during the evaluation and treatment phases of
the protocol
In addition to the general exclusion criteria, these individuals will be excluded for
Clinically significant laboratory abnormalities including positive test for syphilis
Use of immunosuppressive drugs such as systemic (but not topical or inhalant) steroids
(RPR), HBsAg, anti-HCV, anti-HIV
and cytotoxic agents
Chronic medication use will be evaluated in a case-by-case basis
History of any recognized autoimmune disease such as rheumatoid arthritis, vasculitis
systemic erythematous lupus, etc
Serious pre-existing or concurrent chronic medical or psychiatric illnesses other than
All study participants must agree to allow their samples to be used for future
EXCLUSION CRITERIA FOR PTLDS PATIENTS AND LYME ARTHRITIS CONTROLS
Lyme disease
research
Past history of significant head trauma, alcohol or substance abuse in the past 5
years or other medical illness that might produce neurologic deficit (such as
cerebrovascular disease)
Use of systemic antibiotics in the previous month
Patients will be excluded from this protocol if they are judged by the principal
Use of immunomodulators such as interferons
investigator as having a significant impairment in their capacity for judgment and
Chronic medication use will be evaluated in a case-by-case basis
reasoning that compromise their ability to make decisions in their best interest
EXCLUSION CRITERIA FOR RECOVERED, SEROPOSITIVE, OSPA VACCINATED AND HEALTHY VOLUNTEERS
In addition to the above applicable exclusion criteria (general exclusion criteria and
CONTROLS
exclusion criteria for PTLDS patients and Lyme arthritis controls), these individuals will
be excluded for
Pre-existing or concurrent serious chronic medical or psychiatric illness
In addition to the above general exclusion criteria, these individuals will be excluded
EXCLUSION CRITERIA FOR MULTIPLE SCLEROSIS CONTROLS
Pre-existing or concurrent serious psychiatric or chronic medical illness besides
Multiple Sclerosis
for
Past history of significant head trauma, alcohol or substance abuse in the past 5
years or other medical illness, besides Multiple Sclerosis, that might produce
neurologic deficit (such as cerebrovascular disease)
Previously received total lymphoid irradiation (TLI) or cladribine
preceding the study
ELIGIBILITY OF SPECIAL POPULATIONS
In the three months prior to the study initiation, was given such investigational
treatments as plasmapheresis, hyperbaric oxygen, gangliosides, Copolymer 1, etc
Children: Children 13 years and older are eligible to participate in the PTLDS cohort
Has used immunoactive medications (excluding beta-interferon) in the three months
Pregnant and lactating women: Pregnant and lactating women are excluded from study
participation. An enrolled participant who becomes pregnant during the study will be
withdrawn
Adults who lack capacity to consent: Adults who lack decision-making capacity to provide
informed consent are excluded at screening, and enrolled adult participants who permanently
because the condition under study can affect children. This age was selected as appropriate
lose the ability to consent during study participation will be withdrawn
for the children to provide assent to and comply with the study procedures. Children
NIH staff members: NIH staff may be enrolled if they meet eligibility criteria. Neither
younger than 13 will be excluded from the PTLDS cohort, and no children will be enrolled in
participation nor refusal to participate as a subject in the research will have an effect
the other study cohorts
either beneficial or adverse, on the participant s employment or position at NIH. Every
effort will be made to protect participant information, but such information may be
available in medical records and may be available to authorized users outside of the study
team in both an identifiable and unidentifiable manner
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