Clinical trial NCT03201042: Lyme Test Indication Combinations (LyTIC) Study
Official title: Lyme Test Indication Combinations (LyTIC) Study
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Lyme Disease
Lead sponsor: Oxford Immunotec
Sponsor class: INDUSTRY
First posted: 2017-06-28
Enrollment: 410
Sex: ALL
Minimum age (years): 5
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 500 subjects aged 5 years or older.

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

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.

Eligibility 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.

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