NL-OMON36027尚未招募不适用
Comparison of assays for Borrelia detection - PLEASE Addendum
niversitair Medisch Centrum Sint Radboud0 个研究点目标入组 150 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 150
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •The present study is an addendum to the PLEASE study. Patients in this addendum are derived from the PLEASE study, and subsequently the same inclusion criteria apply:
- •a. Males or non-pregnant, non-lactating females who are 18 years or older.
- •b. Women of child-bearing potential must agree to use contraception methods other than oral contraceptives during the study therapy period, since failure of oral contraceptives due to long-term antibiotic use has been described and doxycycline might be teratogenic.
- •c. Patients with presumed or proven PLD. In this study, clinical suspicion of PLD is defined as complaints of musculoskeletal pain, arthritis or arthralgia, neuralgia or sensory disturbances (such as paraesthesias or dysesthesias), neuropsychological or cognitive disorders, and persistent fatigue, that are:
- •(1) temporally related to an episode of erythema migrans or otherwise proven symptomatic Lyme disease (defined as within 4 months after erythema migrans as assessed by a physician, or positive biopsy, PCR, culture, intrathecal B. burgdorferi antibodies), OR
- •(2) accompanied by a positive B. burgdorferi IgG or IgM immunoblot (as defined by strict criteria in line with the European Union Concerted Action on Lyme Borreliosis (EUCALB) and manufacturer of the immunoblot; see appendix A), regardless of prior ELISA IgG/IgM screening results.
- •d. Subjects must sign a written informed consent form.;A matched healthy control is defined as:
- •a. An adult with the same gender as the index patient (if possible)
- •b. No more than 10 years difference in age
- •c. Residence in the same neighbourhood
排除标准
- •The present study is an addendum to the PLEASE study. Patients in this addendum are derived from the PLEASE study, and subsequently the same exclusion criteria apply:
- •a. Subjects with a known history of allergy or intolerance to tetracyclines, macrolides, hydroxychloroquine or ceftriaxone.
- •b. Subjects who have had more than 5 days of antimicrobial therapy with activity against B. burgdorferi within the previous 4 weeks.
- •c. Subjects with a presumed diagnosis of neuroborreliosis (CSF pleiocytosis or intrathecal antibody production) for which intravenous antimicrobial therapy is required.
- •d. Subjects with a known diagnosis of HIV-seropositivity or other immune disorders. (No HIV serologic testing is required for the study).
- •e. Subjects with positive syphilis serology or signs of other spirochetal diseases.
- •f. Subjects with moderate or severe liver disease defined as alkaline phosphatase, ALAT, or ASAT greater than 3 times upper limit of normal.
- •g. Subjects who are receiving and cannot discontinue cisapride, astemizole, terfenadine, barbiturates, phenytoin, or carbamazepine (the concentrations of these drugs may increase during claritromycin therapy and/or lead to reduced availability of doxycycline).
- •h. Subjects who are currently enrolled on other investigational drug trials or receiving investigational agents.
- •i. Subjects who have been previously randomized into this study.
- •j. Severe physical or psychiatric co-morbidity that interferes with participation in the study protocol, including previous medical diagnosis of rheumatic conditions, chronic fatigue syndrome or chronic pain conditions as well as insufficient command of the Dutch language.
- •k. Co-morbidity that could (partially) account for the symptoms of the subject (e.g. vitamin B12 deficiency, anemia, hypothyroidism).;Exclusion criteria healthy controls
- •a. Symptoms of PLD: i.e.musculoskeletal pain, arthritis, neuralgia or sensory disturbances (such as paraesthesias or dysesthesias), neuro-psychological or cognitive disorders and persistent fatigue.
- •b. History of erythema migrans or treatment for Lyme disease.
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