Lyme Test Indication Combinations (LyTIC) Study

Oxford Immunotec

Status: Terminated

Conditions: Lyme Disease

Treatments: Diagnostic Test: PCR based assay; Diagnostic Test: Tcell based assay; Diagnostic Test: Serology based assay

Study type: Observational

Funder types: Industry

Identifiers

NCT03201042

L3

Details and patient eligibility

About

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

Full 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.

Enrollment: 410 patients

Sex: All

Ages: 5+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

410 participants in 3 patient groups

1a:Lyme patients- Erythema Migrans(EM)rash present

Description:

Patients with newly diagnosed Lyme disease based on the presence of a physician-documented EM rash. PCR, serology and Tcell based assay.

Treatment:

Diagnostic Test: Serology based assay

Diagnostic Test: PCR based assay

Diagnostic Test: Tcell based assay

1b:Lyme patients no typical EM

Description:

Patients documented symptoms of early Lyme disease, without a typical EM rash present, and the physician's intention to treat for Lyme disease. PCR, serology and Tcell based assay

Treatment:

Diagnostic Test: Serology based assay

Diagnostic Test: PCR based assay

Diagnostic Test: Tcell based assay

Cohort 2: healthy controls

Description:

Patients drawn from Lyme disease non-endemic areas and subjects with known exposure to Lyme disease will be excluded. PCR, serology and Tcell based assay.

Treatment:

Diagnostic Test: Serology based assay

Diagnostic Test: PCR based assay

Diagnostic Test: Tcell based assay