Lyme Borreliosis
Conditions
Keywords
Lyme Borreliosis, Lyme disease, In Vitro Diagnostics System, Dark Field Microscopy
Brief summary
The clinical data from the clinical trial will be used to assess the performance, sensitivity and specificity of the experimental DualDur In Vitro Diagnostic System.
Detailed description
The clinical data from the clinical trial will be used to assess the performance, sensitivity and specificity of the experimental DualDur In Vitro Diagnostic System. * 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.
Interventions
DIAGNOSTIC_TESTDualDur 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.
DIAGNOSTIC_TESTDualDur 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.
DIAGNOSTIC_TESTWestern 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.
DIAGNOSTIC_TESTBózsik 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.
DIAGNOSTIC_TESTenzyme-linked immunosorbent assay (ELISA) IgM and IgG
Standard ELISA test for Lyme borreliosis.
DIAGNOSTIC_TESTDualDur Polymerase chain reaction
DualDur PCR test for Lyme borreliosis.
Sponsors
Pharmahungary Group
Lyme Diagnostics Ltd.
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
I. Positive trial arm I.1. Inclusion Criteria: * Man or female subjects over 18 years of age * 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. I. 2.
Exclusion criteria
* 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 * 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 II.1. Inclusion Criteria: * 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. II. 2.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary endpoint, 1 (sensitivity of the experimental DualDur in Vitro Diagnostic System) | Laboratory samples evaluated within 72-144 hours of sampling. | The sensitivity of the experimental DualDur in Vitro Diagnostic System in the positive arm, based on medical diagnosis |
| Primary endpoint, 2 (specificity of the experimental DualDur In Vitro Diagnostic System) | Laboratory samples evaluated within 72-144 hours of sampling. | The specificity of the experimental DualDur In Vitro Diagnostic System in the negative arm, based on medical diagnosis and all the standard laboratory test results |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Secondary endpoint, 1 (sensitivity of the experimental DualDur in Vitro Diagnostic System) | Laboratory samples evaluated within 72-144 hours of sampling. | 1\. The sensitivity of the experimental DualDur in Vitro Diagnostic System, based on medical diagnosis (Lyme borreliosis positive) and direct/indirect diagnostic methods. |
| Secondary endpoint, 2 (Pairwise comparison of the sensitivity of the experimental DualDur in Vitro Diagnostic System and of the direct/indirect diagnostic methods) | Laboratory samples evaluated within 72-144 hours of sampling. | Pairwise comparison of the sensitivity of the experimental DualDur in Vitro Diagnostic System and of the direct/indirect diagnostic methods |
Other
| Measure | Time frame | Description |
|---|---|---|
| Tertiary endpoint (Validation of the image evaluation) | Software evaluation done at planned study completion date, February 2020. | Validation of the image evaluation software applied in the diagnosis of Lyme borreliosis by dark field microscopy. |
Countries
Austria, Czechia, Germany, Hungary, Poland, Slovakia
Outcome results
None listed