Performance Evaluation of the DualDur In Vitro Diagnostic System in the Diagnosis of Lyme Borreliosis
NCT ID: NCT03873974
Last Updated: 2020-03-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
400 participants
OBSERVATIONAL
2019-07-02
2019-12-04
Brief Summary
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Detailed Description
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* The sensitivity of the DualDur in Vitro Diagnostic System will be examined in subjects whose physician indicates drug therapy for Lyme borreliosis (positive arm).
* The specificity of the DualDur in Vitro Diagnostic System will be examined in healthy volunteers declared Lyme borreliosis negative by their physician and all the standard laboratory tests prove that they are free of Lyme borreliosis (negative arm).
The diagnostic system developed by Lyme Diagnostics Ltd. is planned for application in the diagnosis during the entire life cycle of Lyme borreliosis.
Conditions
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Study Design
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OTHER
PROSPECTIVE
Study Groups
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Negative trial arm
Venous blood samples will be taken for central laboratory analysis with:
* DualDur dark-field microscopic test
* DualDur dark-field automatic microscopic test
* Western blot IgM and IgG
* Bózsik Western blot IgM and IgG
* Enzyme-Linked Immunosorbent Assay (ELISA) IgM and IgG
* DualDur Polymerase chain reaction
DualDur dark-field automatic microscopic test
Morphologically identify the presence of Borrelia burgdorferi sensu lato bacteria (in a broader sense) which are present in the body fluid, hence to verify Borreliosis. Software evaluation.
Western blot IgM and IgG
Borrelia qualitative in vitro test in order to detect and reliably identify IgG and IgM antibodies against Borrelia burgdorferi from human serum or plasma.
Bózsik Western blot IgM and IgG
Borrelia qualitative in vitro test in order to detect and reliably identify IgG and IgM antibodies against Borrelia burgdorferi from human serum or plasma.
enzyme-linked immunosorbent assay (ELISA) IgM and IgG
Standard ELISA test for Lyme borreliosis.
DualDur dark-field microscopic test
Morphologically identify the presence of Borrelia burgdorferi sensu lato bacteria (in a broader sense) which are present in the body fluid, hence to verify Borreliosis. Manual evaluation.
DualDur Polymerase chain reaction
DualDur PCR test for Lyme borreliosis.
Positive trial arm
Venous blood samples will be taken for central laboratory analysis with:
* DualDur dark-field microscopic test
* DualDur dark-field automatic microscopic test
* Western blot IgM and IgG
* Bózsik Western blot IgM and IgG
* Enzyme-Linked Immunosorbent Assay (ELISA) IgM and IgG
* DualDur Polymerase chain reaction
DualDur dark-field automatic microscopic test
Morphologically identify the presence of Borrelia burgdorferi sensu lato bacteria (in a broader sense) which are present in the body fluid, hence to verify Borreliosis. Software evaluation.
Western blot IgM and IgG
Borrelia qualitative in vitro test in order to detect and reliably identify IgG and IgM antibodies against Borrelia burgdorferi from human serum or plasma.
Bózsik Western blot IgM and IgG
Borrelia qualitative in vitro test in order to detect and reliably identify IgG and IgM antibodies against Borrelia burgdorferi from human serum or plasma.
enzyme-linked immunosorbent assay (ELISA) IgM and IgG
Standard ELISA test for Lyme borreliosis.
DualDur dark-field microscopic test
Morphologically identify the presence of Borrelia burgdorferi sensu lato bacteria (in a broader sense) which are present in the body fluid, hence to verify Borreliosis. Manual evaluation.
DualDur Polymerase chain reaction
DualDur PCR test for Lyme borreliosis.
Interventions
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DualDur dark-field automatic microscopic test
Morphologically identify the presence of Borrelia burgdorferi sensu lato bacteria (in a broader sense) which are present in the body fluid, hence to verify Borreliosis. Software evaluation.
Western blot IgM and IgG
Borrelia qualitative in vitro test in order to detect and reliably identify IgG and IgM antibodies against Borrelia burgdorferi from human serum or plasma.
Bózsik Western blot IgM and IgG
Borrelia qualitative in vitro test in order to detect and reliably identify IgG and IgM antibodies against Borrelia burgdorferi from human serum or plasma.
enzyme-linked immunosorbent assay (ELISA) IgM and IgG
Standard ELISA test for Lyme borreliosis.
DualDur dark-field microscopic test
Morphologically identify the presence of Borrelia burgdorferi sensu lato bacteria (in a broader sense) which are present in the body fluid, hence to verify Borreliosis. Manual evaluation.
DualDur Polymerase chain reaction
DualDur PCR test for Lyme borreliosis.
Eligibility Criteria
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Inclusion Criteria
* Treatment-naive or treatment-experienced subjects with Lyme borreliosis, whose physician indicates drug therapy for Lyme borreliosis.
* Subjects capable of reading, understanding, and observing the requirements of the clinical trial, who sign the Patient Information Leaflet and Informed Consent Form approved by the Competent Authority and the Ethics Committee.
* Man or female subjects over 18 years of age
* Asymptomatic healthy volunteer subjects without acute or chronic symptoms of Lyme borreliosis, who are free of Lyme borreliosis by the indication of all standard laboratory tests, and who are willing to take part in a comprehensive medical examination and related blood sampling.
* Subjects capable of reading, understanding, and observing the requirements of the trial, who sign the Patient Information Leaflet and Informed Consent Form approved by the Competent Authority and the Ethics Committee.
Exclusion Criteria
* Pregnancy, breastfeeding
* History of any complication related to previous blood sampling
* Coagulation and/or bleeding disorders
* Anticoagulant therapy
* Acute, life-threatening condition
* Participation in another clinical trial
* The patient is under antibiotic therapy, or received such treatment in the preceding 3 months
* The patient is currently taking or has taken in the preceding 6 months dietary supplements of herbal origin, or medicinal herbs as first-line or add-on treatments for Lyme borreliosis
* In the event the patient has previously been treated for Lyme borreliosis, then this treatment took place less than 6 months before blood sampling.
* In the preceding 6 months, the patient used an electronic device operating along the principle of electromagnetic (i.e. electric or magnetic) fields - such as bioresonance, pulsed magnetic field, etc. - as add-on treatment for Lyme borreliosis.
II. Negative trial arm
* Man or female subjects over 80 years of age
* Pregnancy, breastfeeding
* History of any complication related to previous blood sampling
* Coagulation and/or bleeding disorders
* Anticoagulant therapy
* Participation in another clinical trial
* Lyme borreliosis diagnosed previously, at any time during the life of the subject
* The subject has received any treatment for Lyme borreliosis (medicinal products, dietary supplements, medicinal plants, electronic devices, etc.) during his/her life
* The patient is under antibiotic therapy, or received such treatment in the preceding 3 months
* The occupation of the subject is either a forester or a hunter
18 Years
ALL
Yes
Sponsors
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Pharmahungary Group
INDUSTRY
Lyme Diagnostics Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Bela P. Bozsik, MD
Role: STUDY_DIRECTOR
Lyme Diagnostics Ltd.
Locations
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MedUni Vienna,University Hospital Internal Medicine I, Clinical Dept. for Infections
Vienna, , Austria
FORBELI s.r.o.
Prague, , Czechia
Neurologická ambulance
Prague, , Czechia
Praxis Dr.med. Reinhardt
Pforzheim, , Germany
Istenhegyi Géndiagnosztika Magánorvosi Rendelő Ltd.
Budapest, , Hungary
St. Luke's Clinic
Gdansk, , Poland
Centrum Dr. Ozimek
Warsaw, , Poland
Borélia centrum Bratislava, BCB Clinic
Bratislava, , Slovakia
Countries
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Related Links
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Official website of study Sponsor, Lyme Diagnostics Ltd.
Official website of central laboratory, Synlab Hungary Ltd.
European Parliament Resolution of 15 November 2018 on Lyme disease (Borreliosis) (2018/2774(RSP)
Official website of CRO, Pharmahungary Group.
Other Identifiers
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LymeDD_CIP
Identifier Type: -
Identifier Source: org_study_id
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