Lyme Test Indication Combinations (LyTIC) Study

Lyme Disease Clinical Trial

— LyTIC  

Official title:

Lyme Test Indication Combinations (LyTIC) Study

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03201042
• Other study ID #: L3
• Status: Terminated
• Start date: June 8, 2017
• Est. completion date: November 30, 2018

Study information

• Verified date: June 2018
• Source: Oxford Immunotec
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 410
• Est. completion date: November 30, 2018
• Est. primary completion date: November 30, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 5 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Lyme Disease

Intervention

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).
• Serology based assay
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. The Immunetics C6 Lyme ELISA assay. A 2-tier Lyme test performed and interpreted according to Centers for Disease Control (CDC) Guidelines 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.

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Oxford Immunotec

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sample Data Analysis	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.	Tests at different time points post inital presentation will be evaluated through study completion, an average of 1 year.