Lyme Test Indication Combinations (LyTIC) Study

Stopped early

Conditions studied: Lyme Disease

In brief

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

Key facts

Study ID

NCT03201042

Run by

Oxford Immunotec

People needed

410

Starts

2017-06-08

Expected to finish

2018-11-30

Last updated by the study team

2018-12-13

Who can join

Age: 5 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Cohort 1a (typical EM and intention to treat):
• Inclusion
• Documented new onset Lyme disease EM rash (single or multiple) with photographic evidence provided to Oxford Immunotec.
• Patient must be able to provide blood sample at the initial visit (prior to treatment initiation) and subsequent samples according to the schedule.
• Patients 5 years of age or older, with a minimum weight of 40 pounds.
• Patient able to read English and to give consent to study participation.
• 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
• 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).
• 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.
• Patient must be able to provide blood sample at the initial visit (prior to treatment initiation) and subsequent samples according to the schedule.
• Patients 5 years of age or older, with a minimum weight of 40 pounds.
• Patient able to read English and to give consent to study participation.
• If patient is younger than 18 years of age a legally authorized representative must provide consent.
• Cohort 2 (Healthy subjects):
• Inclusion
• Subjects 5 years of age or older, with a minimum weight of 40 pounds.
• Subjects never diagnosed with any tick borne disease including Lyme disease
• Subjects able to read English and to give consent to study participation.
• If subject is younger than 18 years of age a legally authorized representative must provide consent.

You may not qualify if…

• Exclusion Cohort 1a (typical EM and intention to treat):
• Patients with Lyme-like symptoms lasting longer than 1 month prior to study enrolment.
• Patients receiving treatment for any tick borne disease (including Lyme disease) prior to enrolment.
• Patients who received a Lyme vaccination.
• Patients with anemia defined as a serum hemoglobin <10gm/dL.
• Patients who are participating in, or plan to participate in, any investigational drug study.
• Patients who are considered unsuitable for the study by the Investigator.
• Cohort 1b (no typical EM; Lyme disease symptoms; intention to treat):
• Patients with Lyme-like symptoms lasting longer than 1 month prior to study enrolment.
• Patients receiving treatment for any tick borne disease (including Lyme disease) prior to enrolment.
• Patients who received a Lyme vaccination.
• Patients with anemia defined as a serum hemoglobin <10gm/dL.
• Patients who are participating in, or plan to participate in, any investigational drug study.
• Patients who are considered unsuitable for the study by the Investigator.
• Cohort 2 (Healthy subjects):
• Exclusion
• Subjects with a history of tick bite
• Subjects with past or current tick borne disease diagnosis
• Subjects at risk for tick borne diseases including Lyme disease
• 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.
• 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.

Where it is running

• Coastal Connecticut Research — New London, Connecticut, United States
• Circle CARE Center — Norwalk, Connecticut, United States
• Orthopaedic Foundation for Active Lifestyles, Inc — Stamford, Connecticut, United States
• Delaware Integrated Medicine — Georgetown, Delaware, United States
• Eastern Research, Inc. — Hialeah, Florida, United States
• South Florida Clinical Trials SFCT, A member of the Alliance, Inc. — Hialeah, Florida, United States
• South Coast Research Center — Miami, Florida, United States
• Advance Clinical Research — Meridian, Idaho, United States
• Acadia Clinical Research — Bangor, Maine, United States
• Integrative Health Center of Maine — Portland, Maine, United States
• Centennial Medical Group — Eldridge, Maryland, United States
• Klein & Associates, MD, PA — Hagerstown, Maryland, United States
• MD Medical Research, Inc. — Oxon Hill, Maryland, United States
• Rockville Internal Medicine Group — Rockville, Maryland, United States
• NECCR Primacare Research,LLC — Fall River, Massachusetts, United States
• Cape Cod Hospital — Hyannis, Massachusetts, United States
• Metromedic Walk In — New Bedford, Massachusetts, United States
• The Research Institute — Springfield, Massachusetts, United States
• NECCR Primacare Research, LLC — Westford, Massachusetts, United States
• Clinical Pharmacology Study Group — Worcester, Massachusetts, United States
• Asthma and Allergy Institute of MI — Clinton Township, Michigan, United States
• Oakland Medical Research — Troy, Michigan, United States
• Pinnacle Research — Sartell, Minnesota, United States
• Andrea Gaito — Basking Ridge, New Jersey, United States
• Paradigm Clinical Research — Redding, California, United States

Full record on ClinicalTrials.gov

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