NCT03201042终止不适用
Lyme Test Indication Combinations (LyTIC) Study
Oxford Immunotec59 个研究点 分布在 1 个国家目标入组 410 人开始时间: 2017年6月8日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 410
- 试验地点
- 59
- 主要终点
- Sample Data Analysis
研究概览
简要总结
To establish performance of individual tests and combinations of tests (serological, molecular and cellular tests) in early Lyme infection diagnosis
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 5 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Cohort 1a (typical EM and intention to treat):
- •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):
- •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):
- •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.
排除标准
- •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):
- •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.
结局指标
主要结局
Sample Data Analysis
时间窗: Tests at different time points post inital presentation will be evaluated through study completion, an average of 1 year.
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.
次要结局
未报告次要终点
研究者
研究点 (59)
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