Lyme Test Indication Combinations (LyTIC) Study



Status:Terminated
Conditions:Infectious Disease
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:5 - Any
Updated:12/15/2018
Start Date:June 8, 2017
End Date:November 30, 2018

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To establish performance of individual tests and combinations of tests (serological,
molecular and cellular tests) in early Lyme infection diagnosis

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.

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.
We found this trial at
60
sites
1343 55th Street
Brooklyn, New York 11219
Principal Investigator: Johnathan Liebowitz, MD
Phone: 718-972-7222
2405
mi
from 98109
Brooklyn, NY
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2095 Langhorne Road
Lynchburg, Virginia 24501
434-847-8400
Principal Investigator: Kappa Meadows, MD
2275
mi
from 98109
Lynchburg, VA
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342 Montauk Avenue
New London, Connecticut 06320
860-443-4567
Principal Investigator: Robert Spitz, MD
2469
mi
from 98109
New London, CT
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3801 Fairfax Drive
Arlington, Virginia 22207
Principal Investigator: Maria Natividad, MD
2319
mi
from 98109
Arlington, VA
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Bangor, Maine 04401
Principal Investigator: Marie Albert, MD
2516
mi
from 98109
Bangor, ME
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1315 Pennsylvania 100
Barto, Pennsylvania 19504
Principal Investigator: Keith Harrison, MD
Phone: 610-845-2011
2338
mi
from 98109
Barto, PA
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211 South Finley Avenue
Basking Ridge, New Jersey 07920
Principal Investigator: Andrea Gaito, MD
Phone: 908-766-0339
2377
mi
from 98109
Basking Ridge, NJ
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Boyertown, Pennsylvania 18512
Principal Investigator: Kenneth Bingener, MD
Phone: 610-367-2259
2338
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from 98109
Boyertown, PA
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699 Stanley Avenue
Brooklyn, New York 11207
Principal Investigator: Ilya Kleyns, MD
2409
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from 98109
Brooklyn, NY
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Brooklyn, New York 12298
Principal Investigator: Victoria Katz, MD
Phone: 718-375-2300
2129
mi
from 98109
Brooklyn, NY
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Burke, Virginia 22015
Principal Investigator: Nashwa Gabra, MD
2314
mi
from 98109
Burke, VA
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Cleveland, Ohio 44122
Principal Investigator: Toby Briskin
Phone: 216-682-0320
2029
mi
from 98109
Cleveland, OH
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Clinton Township, Michigan 48038
Principal Investigator: Jeff Bruner, MD
?
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from 98109
Clinton Township, MI
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555 2nd Avenue
Collegeville, Pennsylvania 19426
Principal Investigator: Paul Doghramji, MD
Phone: 610-454-7750
2352
mi
from 98109
Collegeville, PA
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65 Highview Boulevard
Columbus, Ohio 43207
Principal Investigator: Robert Florea, MD
Phone: 614-850-7450
2011
mi
from 98109
Columbus, OH
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1244 Cornerstone Boulevard
Downingtown, Pennsylvania 19335
Principal Investigator: Lawrence Alwine, MD
2347
mi
from 98109
Downingtown, PA
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Duncansville, Pennsylvania 16635
Principal Investigator: Alan Kivitz, MD
2206
mi
from 98109
Duncansville, PA
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160 West Germantown Pike
East Norriton, Pennsylvania 19401
Principal Investigator: Steven Shapiro, MD
Phone: 215-528-9720
2359
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from 98109
East Norriton, PA
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East Providence, Rhode Island 02914
Principal Investigator: Ronald Gilman, MD
2487
mi
from 98109
East Providence, RI
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8186 Lark Brown Road
Eldridge, Maryland 21075
Principal Investigator: Steve Geller, MD
Phone: 410-730-3399
2323
mi
from 98109
Eldridge, MD
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Endwell, New York 13760
Principal Investigator: James Holler, MD
2264
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from 98109
Endwell, NY
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Erie, Pennsylvania 16506
Principal Investigator: Bradley Fox, MD
Phone: 814-838-9828
2076
mi
from 98109
Erie, PA
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Fall River, Massachusetts 02721
Principal Investigator: Ehab Sorial, MD
2399
mi
from 98109
Fall River, MA
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220 Ridgedale Avenue
Florham Park, New Jersey 07932
Principal Investigator: Max Deshaw, MD
2381
mi
from 98109
Florham Park, NJ
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14715 70th Road
Flushing, New York 11367
Principal Investigator: David Hurwitz, MD
Phone: 718-520-1707
2410
mi
from 98109
Flushing, NY
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Georgetown, Delaware 19958
Principal Investigator: Henry Childers, MD
Phone: 302-362-8726
2406
mi
from 98109
Georgetown, DE
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11 Murray Street
Glens Falls, New York 12801
Principal Investigator: Andrew Garner, MD
2338
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from 98109
Glens Falls, NY
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Hagerstown, Maryland 21740
Principal Investigator: Mary Howell, MD
2265
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from 98109
Hagerstown, MD
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Hialeah, Florida 33013
Principal Investigator: Wilfrido Benitez, MD
Phone: 305-681-3111
2725
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from 98109
Hialeah, FL
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Hialeah, Florida 33016
Principal Investigator: Carlito Arrogante, MD
Phone: 310-289-8242
2724
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from 98109
Hialeah, FL
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206 Commerce Street
Hinesburg, Vermont 05461
Principal Investigator: Roger Giroux, MD
2334
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from 98109
Hinesburg, VT
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Hyannis, Massachusetts 02601
Principal Investigator: Pat Cahill, MD
Phone: 508-495-7190
2543
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from 98109
Hyannis, MA
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Lansdale, Pennsylvania 19446
Principal Investigator: Robert Detweiler, MD
2358
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from 98109
Lansdale, PA
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Lansdale, Pennsylvania 19446
Principal Investigator: Jack Rosenfeld, MD
Phone: 215-361-7164
2358
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from 98109
Lansdale, PA
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Lincoln, Rhode Island 02865
Principal Investigator: Scott Wilson, MD
?
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from 98109
Lincoln, RI
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Lytle, Texas 78052
Principal Investigator: Richard Martinez, MD
1786
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from 98109
Lytle, TX
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Manassas, Virginia 20110
Principal Investigator: Nabil Andrawis, MD
2306
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from 98109
Manassas, VA
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107 Chesley Drive
Media, Pennsylvania 19063
Principal Investigator: Shivkumar Hatti, MD
2365
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from 98109
Media, PA
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Meridian, Idaho 83642
Principal Investigator: Corey Huffine, MD
Phone: 208-377-8653
401
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from 98109
Meridian, ID
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Miami, Florida 33136
Principal Investigator: Adonis Maiquez, MD
Phone: 786-343-6937
2731
mi
from 98109
Miami, FL
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Morgantown, West Virginia
Principal Investigator: Ward Paine, MD
Phone: 304-216-2411
2161
mi
from 98109
Morgantown, WV
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827 Pleasant Street
New Bedford, Massachusetts 02740
Principal Investigator: Tushar Patel, MD
2514
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from 98109
New Bedford, MA
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545 8th Avenue
New York, New York 10022
Principal Investigator: Scott Bloom, MD
Phone: 646-625-3011
2401
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from 98109
New York, NY
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17 Oakwood Terrace
Newburgh, New York 12550
Principal Investigator: Sashi Makam, MD
Phone: 844-337-8839
2376
mi
from 98109
Newburgh, NY
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Norwalk, Connecticut 06851
Principal Investigator: David Rubin, MD
Phone: 203-852-9525
2416
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from 98109
Norwalk, CT
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Oxon Hill, Maryland 20745
Principal Investigator: Stephen Ong, MD
Phone: 301-839-2008
2327
mi
from 98109
Oxon Hill, MD
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75 North Country Road
Port Jefferson, New York 11777
Principal Investigator: Alan Kaell, MD
2438
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from 98109
Port Jefferson, NY
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222 Auburn Street
Portland, Maine 01430
Principal Investigator: Sean McCloy, MD
2479
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from 98109
Portland, ME
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Portsmouth, Rhode Island 02871
Principal Investigator: Stephen Butler, MD
Phone: 508-672-7450
2500
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from 98109
Portsmouth, RI
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1555 Medical Drive
Pottstown, Pennsylvania 19465
Principal Investigator: Gregory Giamo, MD
Phone: 610-326-0782
2343
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from 98109
Pottstown, PA
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Redding, California 96001
Principal Investigator: Jamshid Saleh, MD
Phone: 530-247-7049
486
mi
from 98109
Redding, CA
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Rockville, Maryland 20854
Principal Investigator: Shishir Khetan, MD
2308
mi
from 98109
Rockville, MD
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307 South Lewis Road
Royersford, Pennsylvania 19468
Principal Investigator: Wade Brosius, MD
Phone: 610-792-0300
2348
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from 98109
Royersford, PA
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Sartell, Minnesota 56377
Principal Investigator: Mark Halstrom, MD
Phone: 320-333-6333
1334
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from 98109
Sartell, MN
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Springfield, Massachusetts 01107
Principal Investigator: Claudia Martorell, MD
Phone: 732-780-7650
2423
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from 98109
Springfield, MA
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Stamford, Connecticut 06905
Principal Investigator: Kevin Plancher, MD
2412
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from 98109
Stamford, CT
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Toledo, Ohio 43617
Principal Investigator: Syed M. Rehman, MD
Phone: 419-843-8815
1930
mi
from 98109
Toledo, OH
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Troy, Michigan 48085
Principal Investigator: Jay sandberg, MD
Phone: 248-828-7500
1922
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from 98109
Troy, MI
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Westford, Massachusetts 02790
Principal Investigator: Nate Cordeiro, MD
Phone: 508-636-0613
2461
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from 98109
Westford, MA
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Worcester, Massachusetts 01610
Principal Investigator: Charles Birbara, MD
2454
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from 98109
Worcester, MA
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