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Trial record 2 of 64 for:    lyme

Lyme Test Indication Combinations (LyTIC) Study (LyTIC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03201042
Recruitment Status : Recruiting
First Posted : June 28, 2017
Last Update Posted : December 1, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
To establish performance of individual tests and combinations of tests (serological, molecular and cellular tests) in early Lyme infection diagnosis

Condition or disease Intervention/treatment
Lyme Disease Diagnostic Test: PCR based assay Diagnostic Test: Serology based assay Diagnostic Test: Tcell based assay

Detailed Description:
The present study aims to investigate the performance characteristics of both established and new assays for Borrelia burgdorferi infection and to assess the relative performance of appropriate combinations of these tests. The study will also investigate the effect of the time course of the infection and its treatment on the outcomes for the various tests. Polymerase Chain Reaction(PCR), serology and T cell based tests will be performed. In addition, tests for Babesia, Anaplasma, Ehrlichia and Rickettsia will also be performed as these pathogens can be carried by the same tick that carries Borrelia and may result in coinfection.

Study Design

Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Lyme Test Indication Combinations (LyTIC) Study
Actual Study Start Date : June 8, 2017
Estimated Primary Completion Date : December 1, 2018
Estimated Study Completion Date : February 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lyme Disease
U.S. FDA Resources

Groups and Cohorts

Group/Cohort Intervention/treatment
1a:Lyme patients- Erythema Migrans(EM)rash present
Patients with newly diagnosed Lyme disease based on the presence of a physician-documented EM rash. PCR, serology and Tcell based assay.
Diagnostic Test: PCR based assay

Whole blood specimens will be tested for the presence of Borrelia DNA by PCR in a two-step test (Imugen). In Cohort 1a and 1b. The first step tests for the presence of any Borrelia DNA. The second step is employed on positive samples and tests for the presence of either B. burgdorferi DNA or B. miyamotoi DNA. Positivity by PCR has a short but early window in the infection cycle for Borrelia burgdorferi and results may enable this window period and diagnosis rates to be better defined.

In addition co-infection PCR analysis will be performed for the presence of Babesia, Anaplasma or Ehrlichia DNA (Imugen).

Diagnostic Test: Serology based assay
  1. The Imugen Lyme Antibody Analysis which includes immunoglobulin M (IgM),immunoglobulin G (IgG), and immunoglobulin A (IgA) antibody capture immunoassay and IgG and IgM based Western blots. In Cohort 1a and 1b.
  2. The Immunetics C6 Lyme ELISA assay.
  3. A 2-tier Lyme test performed and interpreted according to Centers for Disease Control (CDC) Guidelines
  4. A Rickettsia antibody test will be used to identify Spotted Fever and Typhus fever groups infections.

Lyme test methodologies generally indicate a need to run a combination of tests in order to overcome limitations in either sensitivity or specificity of the various individual tests. Performance of all these tests on the same set of samples should enable both individual and combinatorial performance values to be calculated and compared.

Diagnostic Test: Tcell based assay
A research based ELISpot assay will be performed on peripheral blood mononuclear cells (PBMC) extracted from whole blood samples to test for presence of T cells activated against Borrelia antigens. Unlike serology based methods, this signal may not persist over extended periods of time in the absence of Borrelia antigens. The diagnostic window may be different for a test measuring adaptive immune response (i.e. T cells) and thus such test may identify patients with undetectable antibody response and may aid sensitivity of diagnosis.
1b:Lyme patients no typical EM
Patients documented symptoms of early Lyme disease, without a typical EM rash present, and the physician's intention to treat for Lyme disease. PCR, serology and Tcell based assay
Diagnostic Test: PCR based assay

Whole blood specimens will be tested for the presence of Borrelia DNA by PCR in a two-step test (Imugen). In Cohort 1a and 1b. The first step tests for the presence of any Borrelia DNA. The second step is employed on positive samples and tests for the presence of either B. burgdorferi DNA or B. miyamotoi DNA. Positivity by PCR has a short but early window in the infection cycle for Borrelia burgdorferi and results may enable this window period and diagnosis rates to be better defined.

In addition co-infection PCR analysis will be performed for the presence of Babesia, Anaplasma or Ehrlichia DNA (Imugen).

Diagnostic Test: Serology based assay
  1. The Imugen Lyme Antibody Analysis which includes immunoglobulin M (IgM),immunoglobulin G (IgG), and immunoglobulin A (IgA) antibody capture immunoassay and IgG and IgM based Western blots. In Cohort 1a and 1b.
  2. The Immunetics C6 Lyme ELISA assay.
  3. A 2-tier Lyme test performed and interpreted according to Centers for Disease Control (CDC) Guidelines
  4. A Rickettsia antibody test will be used to identify Spotted Fever and Typhus fever groups infections.

Lyme test methodologies generally indicate a need to run a combination of tests in order to overcome limitations in either sensitivity or specificity of the various individual tests. Performance of all these tests on the same set of samples should enable both individual and combinatorial performance values to be calculated and compared.

Diagnostic Test: Tcell based assay
A research based ELISpot assay will be performed on peripheral blood mononuclear cells (PBMC) extracted from whole blood samples to test for presence of T cells activated against Borrelia antigens. Unlike serology based methods, this signal may not persist over extended periods of time in the absence of Borrelia antigens. The diagnostic window may be different for a test measuring adaptive immune response (i.e. T cells) and thus such test may identify patients with undetectable antibody response and may aid sensitivity of diagnosis.
Cohort 2: healthy controls
Patients drawn from Lyme disease non-endemic areas and subjects with known exposure to Lyme disease will be excluded. PCR, serology and Tcell based assay.
Diagnostic Test: PCR based assay

Whole blood specimens will be tested for the presence of Borrelia DNA by PCR in a two-step test (Imugen). In Cohort 1a and 1b. The first step tests for the presence of any Borrelia DNA. The second step is employed on positive samples and tests for the presence of either B. burgdorferi DNA or B. miyamotoi DNA. Positivity by PCR has a short but early window in the infection cycle for Borrelia burgdorferi and results may enable this window period and diagnosis rates to be better defined.

In addition co-infection PCR analysis will be performed for the presence of Babesia, Anaplasma or Ehrlichia DNA (Imugen).

Diagnostic Test: Serology based assay
  1. The Imugen Lyme Antibody Analysis which includes immunoglobulin M (IgM),immunoglobulin G (IgG), and immunoglobulin A (IgA) antibody capture immunoassay and IgG and IgM based Western blots. In Cohort 1a and 1b.
  2. The Immunetics C6 Lyme ELISA assay.
  3. A 2-tier Lyme test performed and interpreted according to Centers for Disease Control (CDC) Guidelines
  4. A Rickettsia antibody test will be used to identify Spotted Fever and Typhus fever groups infections.

Lyme test methodologies generally indicate a need to run a combination of tests in order to overcome limitations in either sensitivity or specificity of the various individual tests. Performance of all these tests on the same set of samples should enable both individual and combinatorial performance values to be calculated and compared.

Diagnostic Test: Tcell based assay
A research based ELISpot assay will be performed on peripheral blood mononuclear cells (PBMC) extracted from whole blood samples to test for presence of T cells activated against Borrelia antigens. Unlike serology based methods, this signal may not persist over extended periods of time in the absence of Borrelia antigens. The diagnostic window may be different for a test measuring adaptive immune response (i.e. T cells) and thus such test may identify patients with undetectable antibody response and may aid sensitivity of diagnosis.


Outcome Measures

Primary Outcome Measures :
  1. Sample Data Analysis [ Time Frame: Tests at different time points post inital presentation will be evaluated through study completion, an average of 1 year. ]
    The results will be used to calculate performance, including sensitivity and specificity of the tests under evaluation. The utility of these tests at different time points post initial presentation will be evaluated.


Biospecimen Retention:   Samples Without DNA
whole blood serum

Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   5 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
500 subjects aged 5 years or older.
Criteria

Inclusion Criteria:

  • Cohort 1a (typical EM and intention to treat):

Inclusion

  1. Documented new onset Lyme disease EM rash (single or multiple) with photographic evidence provided to Oxford Immunotec.
  2. Patient must be able to provide blood sample at the initial visit (prior to treatment initiation) and subsequent samples according to the schedule.
  3. Patients 5 years of age or older, with a minimum weight of 40 pounds.
  4. Patient able to read English and to give consent to study participation.
  5. If patient is younger than 18 years of age a legally authorized representative must provide consent.

Cohort 1b (no typical EM; Lyme disease symptoms; intention to treat):

Inclusion

  1. Patients with suspected Lyme disease, based on physician's examination, where the physician has the intention to treat for Lyme disease (i.e. patients who following initial examination were prescribed treatment for Lyme disease).
  2. Documented new onset of Lyme disease symptoms without a typical EM rash or with no rash. If a rash is present, photographic evidence must be provided.
  3. Patient must be able to provide blood sample at the initial visit (prior to treatment initiation) and subsequent samples according to the schedule.
  4. Patients 5 years of age or older, with a minimum weight of 40 pounds.
  5. Patient able to read English and to give consent to study participation.
  6. If patient is younger than 18 years of age a legally authorized representative must provide consent.

Cohort 2 (Healthy subjects):

Inclusion

  1. Subjects 5 years of age or older, with a minimum weight of 40 pounds.
  2. Subjects never diagnosed with any tick borne disease including Lyme disease
  3. Subjects able to read English and to give consent to study participation.
  4. If subject is younger than 18 years of age a legally authorized representative must provide consent.

Exclusion Criteria:

  • Exclusion Cohort 1a (typical EM and intention to treat):

    1. Patients with Lyme-like symptoms lasting longer than 1 month prior to study enrolment.
    2. Patients receiving treatment for any tick borne disease (including Lyme disease) prior to enrolment.
    3. Patients who received a Lyme vaccination.
    4. Patients with anemia defined as a serum hemoglobin <10gm/dL.
    5. Patients who are participating in, or plan to participate in, any investigational drug study.
    6. Patients who are considered unsuitable for the study by the Investigator.

Cohort 1b (no typical EM; Lyme disease symptoms; intention to treat):

  1. Patients with Lyme-like symptoms lasting longer than 1 month prior to study enrolment.
  2. Patients receiving treatment for any tick borne disease (including Lyme disease) prior to enrolment.
  3. Patients who received a Lyme vaccination.
  4. Patients with anemia defined as a serum hemoglobin <10gm/dL.
  5. Patients who are participating in, or plan to participate in, any investigational drug study.
  6. Patients who are considered unsuitable for the study by the Investigator.

Cohort 2 (Healthy subjects):

Exclusion

  1. Subjects with a history of tick bite
  2. Subjects with past or current tick borne disease diagnosis
  3. Subjects at risk for tick borne diseases including Lyme disease
  4. Subjects residing in endemic regions for tick borne diseases: Connecticut, Delaware, Maine, Maryland, Massachusetts, Minnesota, New Hampshire, New Jersey, New York, Pennsylvania, Rhode Island, Vermont, Virginia and Wisconsin.
  5. Subjects who have ever visited non-urban areas of endemic regions for tick borne diseases: Connecticut, Delaware, Maine, Maryland, Massachusetts, Minnesota, New Hampshire, New Jersey, New York, Pennsylvania, Rhode Island, Vermont, Virginia and Wisconsin.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03201042


Contacts
Contact: Sharon Lynch 508-281-5707 slynch@oxfordimmunotec.com
Contact: Barbara Dimento 508-535-2422 bdimento@oxfordimmunotec.com

  Hide Study Locations
Locations
United States, Connecticut
Coastal Connecticut Research Recruiting
New London, Connecticut, United States, 06320
Contact: Diane Palmer       diane@ccrstudies.com   
Principal Investigator: Robert Spitz, MD         
Orthopaedic Foundation for Active Lifestyles, Inc Recruiting
Stamford, Connecticut, United States, 06905
Contact: Stephanie Petterson       spetterson@ofals.org   
Principal Investigator: Kevin Plancher, MD         
United States, Florida
Eastern Research, Inc. Recruiting
Hialeah, Florida, United States, 33013
Contact: Kali Ghazali    305-681-3111    kghazali@trialconnections.com   
Principal Investigator: Wilfrido Benitez, MD         
South Coast Research Center Recruiting
Miami, Florida, United States, 33136
Contact: Richard Garcia    786-343-6937    sc3@southresearch.org   
Principal Investigator: Adonis Maiquez, MD         
United States, Idaho
Advance Clinical Research Recruiting
Meridian, Idaho, United States, 83642
Contact: T Christianson    208-377-8653 ext 105    tchristianson@acr-research.com   
Principal Investigator: Corey Huffine, MD         
United States, Maine
Acadia Clinical Research Recruiting
Bangor, Maine, United States, 04401
Contact: Gail Ballargeon       gail@acadiaclinical.com   
Principal Investigator: Marie Albert, MD         
Integrative Health Center of Maine Recruiting
Portland, Maine, United States, 01430
Contact: Deborah Robb       deborah@mainintergrative.com   
Principal Investigator: Sean McCloy, MD         
United States, Maryland
Centennial Medical Group Recruiting
Eldridge, Maryland, United States, 21075
Contact: Andrea Henry    410-730-3399    ahenry@centennialmedical.com   
Principal Investigator: Steve Geller, MD         
Klein & Associates, MD, PA Recruiting
Hagerstown, Maryland, United States, 21740
Contact: Brenda Spotts       bspotts@rheumdocs.com   
Principal Investigator: Mary Howell, MD         
MD Medical Research, Inc. Recruiting
Oxon Hill, Maryland, United States, 20745
Contact: Spencer Ong    301-839-2008    spencer.ong@mdmedicalresearch.com   
Principal Investigator: Stephen Ong, MD         
Rockville Internal Medicine Group Recruiting
Rockville, Maryland, United States, 20854
Contact: Michelle Spence       mspence@priviamedicalgroup.com   
Principal Investigator: Shishir Khetan, MD         
United States, Massachusetts
NECCR Primacare Research,LLC Recruiting
Fall River, Massachusetts, United States, 02721
Contact: Mark Bergeron       mbergeron@neccr.com   
Principal Investigator: Ehab Sorial, MD         
Cape Cod Hospital Recruiting
Hyannis, Massachusetts, United States, 02601
Contact: Susa Pina    508-495-7190    pjcahill@capecodhealth.org   
Principal Investigator: Pat Cahill, MD         
Metromedic Walk In Recruiting
New Bedford, Massachusetts, United States, 02740
Contact: Nauka Patel       fallrivercr@gmail.com   
Principal Investigator: Tushar Patel, MD         
The Research Institute Recruiting
Springfield, Massachusetts, United States, 01105
Contact: Jacqueline Rivera    732-780-7650    jacquelinerivera@idresearchinstitute.com   
Principal Investigator: Claudia Martorell, MD         
NECCR Primacare Research, LLC Recruiting
Westford, Massachusetts, United States, 02790
Contact: Mark Bergeron    508-636-0613    ncordeiro@neccr.com   
Principal Investigator: Nate Cordeiro, MD         
Clinical Pharmacology Study Group Recruiting
Worcester, Massachusetts, United States, 01605
Contact: Mary Coughlin, RN       cpsgworc@aol.com   
Principal Investigator: Charles Birbara, MD         
United States, Michigan
Asthma and Allergy Institute of MI Recruiting
Clinton Township, Michigan, United States, 48038
Contact: Elaine Oakes       eoaaiom@gmail.com   
Principal Investigator: Jeff Bruner, MD         
Oakland Medical Research Recruiting
Troy, Michigan, United States, 48085
Contact: Julie LaFave    248-828-7500    juliejolafave@msn.com   
Principal Investigator: Jay sandberg, MD         
United States, Minnesota
Pinnacle Research Recruiting
Sartell, Minnesota, United States, 56377
Contact: Jen Wipper    320-333-6333    wipperj@pinnacleresearch.org   
Principal Investigator: Mark Halstrom, MD         
United States, New Jersey
Andrea Gaito Recruiting
Basking Ridge, New Jersey, United States, 07920
Contact: Andrea Gaito    908-766-0339    jslutzmd@eclipse.net   
Principal Investigator: Andrea Gaito, MD         
Andrea Gaito Recruiting
Basking Ridge, New Jersey, United States, 07920
Contact: Andrea Gaito, MD       jslutzmd@eclipse.net   
Principal Investigator: Andrea Gaito, MD         
MAffiliated Medical Associates Recruiting
Florham Park, New Jersey, United States, 07932
Contact: Johanna Buck       jcbuck87@gmail.com   
Principal Investigator: Max Deshaw, MD         
United States, New York
Modern Medical Recruiting
Brooklyn, New York, United States, 11207
Contact: Gabe Goldfeder       gg.g2crc@gmail.com   
Principal Investigator: Ilya Kleyns, MD         
Private Practice-Johnathan Liebowitz Recruiting
Brooklyn, New York, United States, 11219
Contact: Casey Brescia    917-714-6157    casey@btcsites.com   
Principal Investigator: Johnathan Liebowitz, MD         
NY Arthritis Clinic Recruiting
Brooklyn, New York, United States, 12298
Contact: Iya Katz    718-375-2300    Iyakatz@yahoo.com   
Principal Investigator: Victoria Katz, MD         
Regional Clinical Research, Inc. Recruiting
Endwell, New York, United States, 13760
Contact: Debra Gabrielson       dgabrielson@rcresearchinc.cm   
Principal Investigator: James Holler, MD         
Private Practice-David Wurwitz Recruiting
Flushing, New York, United States, 11367
Contact: Shilo West    718-520-1707    davidhdoc@aol.com   
Principal Investigator: David Hurwitz, MD         
Mid Hudson Medical Research Recruiting
Newburgh, New York, United States, 12550
Contact: William Chrvala    844-337-8839    wchrvala@mhmresearch.com   
Principal Investigator: Sashi Makam, MD         
John T. Mather Hospital Recruiting
Port Jefferson, New York, United States, 11777
Contact: Robert Lucien Cardinal         
Principal Investigator: Alan Kaell, MD         
United States, Ohio
Buckeye Health and Research Recruiting
Columbus, Ohio, United States, 43207
Contact: Sydney Hossfeld    614-850-7450    sydneyhossfeld@gmail.com   
Contact: Mark Tackett    614-850-7450    marktackett79@gmail.com   
Principal Investigator: Ward Paine, MD         
Toledo Institute of Clinical Research Recruiting
Toledo, Ohio, United States, 43207
Contact: Kehkashan Arshad    419-843-8815    kehkashan.arshad@ohmiallergy.com   
Principal Investigator: Syed M. Rehman, MD         
United States, Pennsylvania
Bally Medical Group Recruiting
Barto, Pennsylvania, United States, 19504
Contact: Deb Zlomek    610-845-2011    dzlomek@pmsiforlife.com   
Principal Investigator: Keith Harrison, MD         
Boyertown Medical Assoc. Recruiting
Boyertown, Pennsylvania, United States, 18512
Contact: Deb Zlomek    610-367-2259    dzlomek@pmsiforlife.com   
Principal Investigator: Kenneth Bingener, MD         
Collegeville Family Practice Recruiting
Collegeville, Pennsylvania, United States, 19426
Contact: Deb Zlomek    610-454-7750    dzlomek@pmsiforlife.com   
Principal Investigator: Paul Doghramji, MD         
Brandywine Clinic Recruiting
Downingtown, Pennsylvania, United States, 19335
Contact: Brittany Thomas       bcr77@comcast.net   
Principal Investigator: Lawrence Alwine, MD         
Altoona Center for Clinical Research Recruiting
Duncansville, Pennsylvania, United States, 16635
Contact: Harley Snyder       harleyweigl@altoonaresearch.com   
Principal Investigator: Alan Kivitz, MD         
Pediatric Medical Associates of NTN/ABG Recruiting
East Norriton, Pennsylvania, United States, 19401
Contact: Shilo West    215-528-9720    researchpma@gmail.com   
Principal Investigator: Steven Shapiro, MD         
Detweiler Family Practice Recruiting
Lansdale, Pennsylvania, United States, 19446
Contact: Allison Fanelli       afanelli@detweilerfamilymedicine.com   
Principal Investigator: Robert Detweiler, MD         
Green and Seidner Family Practice Recruiting
Lansdale, Pennsylvania, United States, 19446
Contact: Renee Backer    215-361-7164    seidneresearch@aol.com   
Principal Investigator: Jack Rosenfeld, MD         
Suburban Research Assoc. Recruiting
Media, Pennsylvania, United States, 19063
Contact: Nadine Varney       shatti@suburbanresearch.com   
Principal Investigator: Shivkumar Hatti, MD         
Suburban Research Assoc. Recruiting
Media, Pennsylvania, United States, 19063
Contact: Nadine Varney         
Principal Investigator: Shivkumar Hatti, MD         
Brookside Family Practice and Pediatrics Recruiting
Pottstown, Pennsylvania, United States, 19465
Contact: Deb Zlomek    610-326-0782    dzlomek@pmsiforlife.com   
Principal Investigator: Gregory Giamo, MD         
Spring-Ford Family Practice Recruiting
Royersford, Pennsylvania, United States, 19468
Contact: Debbie Zlomek    610-792-0300    dzlomek@pmsiforlife.com   
Principal Investigator: Wade Brosius, MD         
United States, Rhode Island
Safe Harbor Clinical Research Recruiting
East Providence, Rhode Island, United States, 02914
Contact: Linda Cannistra       safeharbortrails@aol.com   
Principal Investigator: Ronald Gilman, MD         
Ocean State Clinical Research Recruiting
Lincoln, Rhode Island, United States, 02865
Contact: Peter La Torre       platorreoscr@gmail.com   
Principal Investigator: Scott Wilson, MD         
NECCR Primacare Research, LLC Recruiting
Portsmouth, Rhode Island, United States, 02871
Contact: Mark Bergeron    508-672-7450      
Principal Investigator: Stephen Butler, MD         
United States, Texas
Atascosa Clinical Trial Recruiting
Lytle, Texas, United States, 78052
Contact: Erika DeLagarza       edelagarza.act@outlook.com   
Principal Investigator: Richard Martinez, MD         
United States, Vermont
Brookside Family Health Care Recruiting
Hinesburg, Vermont, United States, 05461
Contact: Roger q Giroux       roger@brooksidehealth.com   
Principal Investigator: Roger Giroux, MD         
United States, Virginia
Millennium Clincial Trials Recruiting
Arlington, Virginia, United States, 22207
Contact: Mary Weiss       mary@mctrials.net   
Principal Investigator: Maria Natividad, MD         
Burke Internal Medicine Recruiting
Burke, Virginia, United States, 22015
Contact: Shilo West       nashwagabra@hotmail.com   
Principal Investigator: Nashwa Gabra, MD         
The Education and Research Foundation, Inc. Recruiting
Lynchburg, Virginia, United States, 24501
Contact: Julie Doyle    434-847-8400    jdoyle@educationandresearch.com   
Principal Investigator: Kappa Meadows, MD         
Manassas Clinical Research Center Recruiting
Manassas, Virginia, United States, 21010
Contact: Shilo West       nandrawis@gmail.com   
Principal Investigator: Nabil Andrawis, MD         
United States, West Virginia
Exemplar Research Recruiting
Morgantown, West Virginia, United States, 26505
Contact: Kali Ghazali    304-216-2411    kghazali@trialconnections.com   
Principal Investigator: Ward Paine, MD         
Sponsors and Collaborators
Oxford Immunotec
More Information

Responsible Party: Oxford Immunotec
ClinicalTrials.gov Identifier: NCT03201042     History of Changes
Other Study ID Numbers: L3
First Posted: June 28, 2017    Key Record Dates
Last Update Posted: December 1, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
Lyme Disease
Borrelia Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Tick-Borne Diseases
Spirochaetales Infections