Performance Evaluation of the DualDur In Vitro Diagnostic System in the Diagnosis of Lyme Borreliosis
Completed
- Conditions
- Lyme Borreliosis
- Interventions
- Diagnostic Test: DualDur dark-field microscopic testDiagnostic Test: DualDur dark-field automatic microscopic testDiagnostic Test: Western blot IgM and IgGDiagnostic Test: Bózsik Western blot IgM and IgGDiagnostic Test: enzyme-linked immunosorbent assay (ELISA) IgM and IgGDiagnostic Test: DualDur Polymerase chain reaction
- Registration Number
- NCT03873974
- Lead Sponsor
- Lyme Diagnostics Ltd.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 400
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. 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
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Negative trial arm DualDur dark-field microscopic test 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 Negative trial arm Western blot IgM and IgG 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 Negative trial arm Bózsik Western blot IgM and IgG 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 Positive trial arm Western blot IgM and IgG 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 Positive trial arm Bózsik Western blot IgM and IgG 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 Negative trial arm enzyme-linked immunosorbent assay (ELISA) IgM and IgG 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 Negative trial arm DualDur Polymerase chain reaction 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 Negative trial arm DualDur dark-field automatic microscopic test 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 Positive trial arm DualDur dark-field microscopic test 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 Positive trial arm DualDur dark-field automatic microscopic test 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 Positive trial arm DualDur Polymerase chain reaction 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 Positive trial arm enzyme-linked immunosorbent assay (ELISA) IgM and IgG 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
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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
Trial Locations
- Locations (8)
FORBELI s.r.o.
🇨🇿Prague, Czechia
Neurologická ambulance
🇨🇿Praha 6, Czechia
MedUni Vienna,University Hospital Internal Medicine I, Clinical Dept. for Infections
🇦🇹Wien, Austria
Borélia centrum Bratislava, BCB Clinic
🇸🇰Bratislava, Slovakia
Praxis Dr.med. Reinhardt
🇩🇪Pforzheim, Germany
Centrum Dr. Ozimek
🇵🇱Warsaw, Poland
St. Luke's Clinic
🇵🇱Gdańsk, Poland
Istenhegyi Géndiagnosztika Magánorvosi Rendelő Ltd.
🇭🇺Budapest, Hungary