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Evaluation of Lyme Disease: Clinical, Microbiological and Immunological

Characteristics

_http://clinicaltrials.gov/ct/show/NCT00001539_

(http://clinicaltrials.gov/ct/show/NCT00001539)

This study is currently recruiting participants.

Verified by National Institutes of Health Clinical Center (CC), January

2009

First Received: November 3, 1999 Last Updated: November 25, 2009

_History of Changes_ (http://clinicaltrials.gov/ct2/archive/NCT00001539)

Sponsor: _National Institute of Allergy and Infectious Diseases (NIAID)_

(http://clinicaltrials.gov/ct2/bye/BQoPWw4lZX-i-iSxuQ7Ge6YxuQ7Ju6c9c.)

Information provided by: National Institutes of Health Clinical Center (CC)

ClinicalTrials.gov Identifier: NCT00001539

Purpose

 

 

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 between 13 and 65 years of age; all

others must be between 18 and 65 years of age. 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 a...

 

_Condition_ (http://clinicaltrials.gov/ct2/help/conditions_desc)

Chronic Disease

Healthy

Lyme Arthritis

Lyme Disease

Multiple Sclerosis

 

 

Study Type: Observational Official Title: A Comprehensive Clinical,

Microbiological and Immunological Assessment of Patients With Suspected Chronic

Lyme Infection and Selected Control Populations

Resource links provided by NLM:

 

 

_MedlinePlus_ (http://www.nlm.nih.gov/medlineplus/) related topics:

_Coping with Chronic Illness_

(http://clinicaltrials.gov/ct2/bye/tQoPWw4lZX-i-iSxudhWudNzlXNiZip9m67PvQ7xzwhaL\

wS90d-3edNi-Q1PlBckSdcxeBczvdhxzw-RuQoPmdt.)

_Lyme Disease_

(http://clinicaltrials.gov/ct2/bye/FQoPWw4lZX-i-iSxudhWudNzlXNiZip9m67PvQ7xzwhaL\

wS9vT7Lz6hzF67GF6DxlihLv.) _Multiple Sclerosis_

(http://clinicaltrials.gov/ct2/bye/xQoPWw4lZX-i-iSxudhWudNzlXNiZip9m67PvQ7xzwhaL\

wS9mi7a

WQ13v61g0dhHSd-gewSxlihLv.)

_U.S. FDA Resources_ (http://clinicaltrials.gov/ct2/info/fdalinks)

 

 

Further study details as provided by National Institutes of Health

Clinical Center (CC):

 

Estimated Enrollment: 440 Study Start March 1996Detailed

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

therapeutics approaches. The goal of this study is to assemble a

well-characterized cohort of patients with presumed chronic Lyme disease and

relevant controls that will yield a prospective database upon which stringent

diagnostic criteria can be established and future therapeutic trials can be

designed.

 

 

 

Eligibility

 

Ages Eligible for Study: 13 Years and older Genders Eligible for

Study: Both Accepts Healthy Volunteers: Yes

Criteria

 

* INCLUSION CRITERIA:

Screening:

Age greater than or equal to 13 years old.

Suspect of suffering from Lyme disease.

Chronic/Post Lyme Disease (CLD): For the purposes of this study, CLD is

defined as occurring in male or female patients age 13 and above who have

been diagnosed with Lyme disease, have received recommended antibiotic therapy

and have persistent symptoms and/or signs for at least six months after

therapy. They also should have no other documented explanation for their

signs and symptoms and have positive serum antibodies to B.burgdorferi

confirmed by Western blot according to the CDC criteria (IgG immunoblot is

considered positive if five of the following 10 bands are present: 18 kDa, 21

kDa

(OspC), 28 kDa, 30 kDa, 39 kDa, 41 kDa (Fla), 45 kDa, 58 kDa (not GroEL), 66

kDa, and 93 kDa).

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 had initial or intermittent episodes of arthritis involving one or

few joints and have continuous joint swelling for more than three months,

without any other cause being documented, and have positive serum antibodies

to B.burgdorferi confirmed by 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 Lyme disease, fulfilling the CDC Lyme Disease National Surveillance Case

Definition and who had received accepted antibiotic treatment for Lyme

disease (at least 3 months since the end of antibiotic therapy before protocol

evaluation) and who are currently asymptomatic.

Seropositive Controls: For the purposes of this study, a serpositive

control is defined as an otherwise healthy male or female aged 18 and above who

has positive serum IgG antibody to B.burgdorferi by Western blot according

to the CDC criteria and are asymptomatic and who recall no episodes of

disease compatible with Lyme infection, and have not received antibiotic

therapy for Lyme disease.

OspA vaccinated control: For the purposes of this study, a OspA vaccinated

control is defined as an otherwise healthy male or female aged 18 and

above who has received at least two doses of the OspA vaccine for Lyme disease

(Lymerix [R]). 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 1 to 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 acute or chronic Lyme disease and negative western blot to

B.burgdorferi in the serum by the CDC criteria.

EXCLUSION CRITERIA:

General exclusion criteria:

Age less than 18 (less than 13 for patients with chronic Lyme disease).

Weight less than 70 Lb (35 kg).

Pregnancy or lactation.

Women with childbearing potential who are sexually active and unwilling to

use effective contraception.

Clinically significant laboratory abnormalities including positive test

for syphilis (RPR), HBsAg, anti-HCV, anti-HIV.

Chronic medication use will be evaluated in a case-by-case basis.

Not able to understand all of the requirements of the study or unable to

give informed consent and/or comply with all aspects of the evaluation.

EXCLUSION CRITERIA FOR CHRONIC LYME DISEASE PATIENTS AND LYME ARTHRITIS

CONTROLS:

In addition to the general exclusion criteria, these individuals will be

excluded for:

1. Use of immunosuppressive drugs such as systemic (but not topical

or inhalant) steroids and cytotoxic agents.

2. History of any recognized autoimmune disease such as rheumatoid

arthritis, vasculitis, systemic erythematous lupus, etc.

3. Serious pre-existing or concurrent chronic medical or psychiatric

illnesses other than Lyme disease.

4. 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).

5. Use of systemic antibiotics in the previous month.

6. Use of immunomodulators such as interferons.

7. Chronic medication use will be evaluated in a case-by-case basis.

8. Patients will be excluded from this protocol if they are judged by

the principal investigator as having a significant impairment in their

capacity for judgment and reasoning that compromise their ability to make

decisions in their best interest.

EXCLUSION CRITERIA FOR RECOVERED, SEROPOSITIVE, OSPA VACCINATED AND

HEALTHY VOLUNTEERS CONTROLS:

In addition to the above applicable exclusion criteria (general criteria

and exclusion criteria for chronic Lyme disease patients and Lyme arthritis

controls), these individuals will be excluded for:

1. Pre-existing or concurrent serious chronic medical or psychiatric

illness.

EXCLUSION CRITERIA FOR MULTIPLE SCLEROSIS CONTROLS:

In addition to the above general exclusion criteria, these individuals

will be excluded for:

1. Pre-existing or concurrent serious psychiatric or chronic medical

illness besides Multiple Sclerosis.

2. 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).

3. Previously received total lymphoid irradiation (TLI) or

cladribine.

4. Has used of immunoactive medications (excluding beta-interferon)

in the three months preceding the study.

5. In the three months prior to the study initiation, was given such

investigational treatments as plasmapheresis, hyperbaric oxygen,

gangliosides, Copolymer 1, etc.

 

 

 

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier:

NCT00001539

 

Contacts

Contact: Patient Recruitment and Public Liaison Office (800) 411-1222

_prpl_ (prpl?subject=NCT00001539, 960052,

Evaluation of Lyme Disease: Clinical, Microbiological and Immunological

Characteristics) Contact: TTY 1-866-411-1010

Locations

United States, Maryland National Institutes of Health Clinical Center,

9000 Rockville Pike Recruiting Bethesda, Maryland, United States, 20892

Sponsors and Collaborators

_National Institute of Allergy and Infectious Diseases (NIAID)_

(http://clinicaltrials.gov/ct2/bye/BQoPWw4lZX-i-iSxuQ7Ge6YxuQ7Ju6c9c.)

 

 

More Information

 

Additional Information:

_NIH Clinical Center Detailed Web Page_

(http://clinicaltrials.gov/ct2/bye/9QoPWw4lZXcgvQ7xeBcGvw-PL6hzzwSxedN6ZXNxeQYxU\

d-BZ6hHWB7zvXWG2RC5xgpLyXCtEgCnu

QoPmdt/zC5znnjgvQ7xeBcGvnjgzdUPzwp3j61PkQ7az6Y3167nJ8hGU6V)

 

Publications:

 

_Hemmer B, Gran B, Zhao Y, Marques A, Pascal J, Tzou A, Kondo T, Cortese

I, Bielekova B, Straus SE, McFarland HF, Houghten R, Simon R, Pinilla C,

Martin R. Identification of candidate T-cell epitopes and molecular mimics in

chronic Lyme disease. Nat Med. 1999 Dec;5(12):1375-82._

(http://clinicaltrials.gov/ct2/bye/zQoPWw4lZX-i-iSxuBcyeXNxvdDxuQ7Ju6c9cXcHuioyz\

Tp9ai7HSTDxNBcie

scgm64LD61PSQ7Hc6D65B0LVi7yg67VN6h9Ei4L3BUgWwNG0iY6vQ1gW1-He6oR9RCtLK4jEgF5.

)

_Liang FT, Steere AC, Marques AR, Johnson BJ, Miller JN, Philipp MT.

Sensitive and specific serodiagnosis of Lyme disease by enzyme-linked

immunosorbent assay with a peptide based on an immunodominant conserved region

of

Borrelia burgdorferi vlsE. J Clin Microbiol. 1999 Dec;37(12):3990-6._

(http://clinicaltrials.gov/ct2/bye/zQoPWw4lZX-i-iSxuBcyeXNxvdDxuQ7Ju6c9cXcHuioyz\

Tp9ai

7HSTDxNBciescgm64LD61PSQ7Hc6D65B0LVi7yg67VN6h9Ei4L3BUgWwNG0iY6vQ1gW1-He6oR9R

CtLg08xR0t.)

_Steere AC, Malawista SE, Hardin JA, Ruddy S, Askenase W, Andiman WA.

Erythema chronicum migrans and Lyme arthritis. The enlarging clinical spectrum.

Ann Intern Med. 1977 Jun;86(6):685-98._

(http://clinicaltrials.gov/ct2/bye/0QoPWw4lZX-i-iSxuBcyeXNxvdDxuQ7Ju6c9cXcHuioyz\

Tp9ai7HSTDxNBciescgm64LD61PSQ7H

c6D65B0LVi7yg67VN6h9Ei4L3BUgWwNG0iY6vQ1gW1-He6oR9K4BxRFVO.)

 

 

Study ID Numbers: 960052, 96-I-0052 Study First Received: November 3, 1999

Last Updated: November 25, 2009 ClinicalTrials.gov Identifier:

_NCT00001539_ (http://clinicaltrials.gov/ct2/show/NCT00001539) _History of

Changes_

(http://clinicaltrials.gov/ct2/archive/NCT00001539) Health Authority:

United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):

Central Nervous System

Lyme Disease

Borrelia Burgdorferi

Neuroborreliosis

Chronic Infection

Lyme Disease

 

 

Additional relevant MeSH terms:

Bacterial Infections

Disease Attributes

Autoimmune Diseases

Immune System Diseases

Demyelinating Diseases

Borrelia Infections

Joint Diseases

Nervous System Diseases

Lyme Disease

Sclerosis

Tick-Borne Diseases

Gram-Negative Bacterial Infections

Multiple Sclerosis

Pathologic Processes

Musculoskeletal Diseases

Spirochaetales Infections

Arthritis

Demyelinating Autoimmune Diseases, CNS

Chronic Disease

Autoimmune Diseases of the Nervous System

 

 

ClinicalTrials.gov processed this record on December 28, 2009