410
Participants
Start Date
June 8, 2017
Primary Completion Date
November 30, 2018
Study Completion Date
November 30, 2018
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)."
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."
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.
NYCT, A member of Alliance, Inc., New York
Modern Medical, Brooklyn
Private Practice-Johnathan Liebowitz, Brooklyn
Private Practice-David Wurwitz, Flushing
John T. Mather Hospital, Port Jefferson
NY Arthritis Clinic, Brooklyn
Mid Hudson Medical Research, Newburgh
Adirondack Medical Research Center, Glens Falls
Regional Clinical Research, Inc., Endwell
Liberty Family Practice/Square 1, Erie
Altoona Center for Clinical Research, Duncansville
Boyertown Medical Assoc., Boyertown
Suburban Research Assoc., Media
Brandywine Clinic, Downingtown
Pediatric Medical Associates of NTN/ABG, East Norriton
Collegeville Family Practice, Collegeville
Detweiler Family Practice, Lansdale
Green and Seidner Family Practice, Lansdale
Brookside Family Practice and Pediatrics, Pottstown
Spring-Ford Family Practice, Royersford
Bally Medical Group, Barto
Delaware Integrated Medicine, Georgetown
MD Medical Research, Inc., Oxon Hill
Rockville Internal Medicine Group, Rockville
Manassas Clinical Research Center, Manassas
Centennial Medical Group, Eldridge
Klein & Associates, MD, PA, Hagerstown
Burke Internal Medicine, Burke
Millennium Clincial Trials, Arlington
The Education and Research Foundation, Inc., Lynchburg
Exemplar Research, Morgantown
Eastern Research, Inc., Hialeah
South Florida Clinical Trials SFCT, A member of the Alliance, Inc., Hialeah
South Coast Research Center, Miami
Buckeye Health and Research, Columbus
Toledo Institute of Clinical Research, Toledo
Rapid Medical Research, Cleveland
Asthma and Allergy Institute of MI, Clinton Township
Oakland Medical Research, Troy
Pinnacle Research, Sartell
Atascosa Clinical Trial, Lytle
Advance Clinical Research, Meridian
Paradigm Clinical Research, Redding
Coastal Connecticut Research, New London
Circle CARE Center, Norwalk
Orthopaedic Foundation for Active Lifestyles, Inc, Stamford
Acadia Clinical Research, Bangor
Integrative Health Center of Maine, Portland
NECCR Primacare Research,LLC, Fall River
Cape Cod Hospital, Hyannis
Metromedic Walk In, New Bedford
The Research Institute, Springfield
NECCR Primacare Research, LLC, Westford
Clinical Pharmacology Study Group, Worcester
Andrea Gaito, Basking Ridge
MAffiliated Medical Associates, Florham Park
Safe Harbor Clinical Research, East Providence
Ocean State Clinical Research, Lincoln
NECCR Primacare Research, LLC, Portsmouth
Brookside Family Health Care, Hinesburg
Lead Sponsor
Oxford Immunotec
INDUSTRY