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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT03201042
Other study ID # L3
Secondary ID
Status Terminated
Phase
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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.
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