Comparison of assays for Borrelia detectio

Conditions: lyme borreliosis
10004018

Registration Number: NL-OMON36027

Lead Sponsor: niversitair Medisch Centrum Sint Radboud

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 150

Inclusion Criteria

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

Exclusion Criteria

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.

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Diagnostic properties of the standard immunoblot used in the UMCN Medical<br /><br>Microbiology laboratory, the EUROLINE-WB: Anti-Borrelia (Whole Antigen plus<br /><br>VlsE), will be compared to RecomLine (Microgen) and antigen detection according<br /><br>to Multiplex Analysis for Flow Cytometry (SERION Multianalyt* Borrelia<br /><br>burgdorferi, Virion/Serion, Germany). In addition, the most commonly used<br /><br>Borrelia PCR in the Netherlands on blood and urine will be applied. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Besides immunoblot testing, serum samples of all participants will be screened<br /><br>as usual for the presence of Borrelia IgG and IgM antibodies by ELISA<br /><br>(Virion-Serion, Clinida Benelux BV).<br /><br><br /><br>Patients and controls complete the following questionnaires for evaluation of<br /><br>physical, psychological, cognitive and generic functioning at baseline:<br /><br>• Medical Outcomes Study 36-item Short-form General Health Survey (SF-36)<br /><br>• Fatigue subscale of Checklist Individual Strength (CIS)<br /><br>• Cognitive Failure Questionnaire (CFQ)<br /><br>• Hospital anxiety and depression score HADS (anxiety and depression) </p><br>