Clinical trial NCT03873974: Performance Evaluation of the DualDur In Vitro Diagnostic System in the Diagnosis of Lyme Borreliosis
Official title: Multicentre Clinical Trial to Assess the Performance of the DualDur In Vitro Diagnostic System in the Diagnosis of Lyme Borreliosis From Blood Samples of Subjects Who Are Either Pharmacotherapy-naive or Treatment-experienced and Their Physician Indicates Drug Therapy for Lyme Borreliosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lyme Borreliosis
Keywords: Lyme Borreliosis
Lyme disease
In Vitro Diagnostics System
Dark Field Microscopy
Lead sponsor: Lyme Diagnostics Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Pharmahungary Group
First posted: 2019-03-14
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Positive trial arm: At least 18-year-old, treatment-naive or treatment-experienced men and women with Lyme borreliosis, whose physician indicates drug therapy for Lyme borreliosis. Furthermore, they consent to the collection and processing of their data during the clinical trial, and to blood sampling for the assessment of the DualDur IVD System, and to the diagnostic analyses of these samples in the central laboratory of the trial.

Negative trial arm: At least 18-year-old healthy volunteers without the symptoms of either acute or chronic Lyme borreliosis, who have not been treated for Lyme borreliosis, and all the standard laboratory tests prove that they are free of Lyme borreliosis.

Furthermore, they give their consent to blood sampling for the purposes of the clinical trial, to the collection and processing of their data, and to the analyses of their blood samples in the central laboratory of the trial.

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.

Eligibility 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. 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

Primary outcomes:
measure: Primary endpoint, 1 (sensitivity of the experimental DualDur in Vitro Diagnostic System)
timeFrame: Laboratory samples evaluated within 72-144 hours of sampling.
measure: Primary endpoint, 2 (specificity of the experimental DualDur In Vitro Diagnostic System)
timeFrame: Laboratory samples evaluated within 72-144 hours of sampling.
Secondary outcomes:
measure: Secondary endpoint, 1 (sensitivity of the experimental DualDur in Vitro Diagnostic System)
timeFrame: Laboratory samples evaluated within 72-144 hours of sampling.
measure: Secondary endpoint, 2 (Pairwise comparison of the sensitivity of the experimental DualDur in Vitro Diagnostic System and of the direct/indirect diagnostic methods)
timeFrame: Laboratory samples evaluated within 72-144 hours of sampling.
Other outcomes:
measure: Tertiary endpoint (Validation of the image evaluation)
timeFrame: Software evaluation done at planned study completion date, February 2020.
Locations:
city: Wien
country: Austria
facility: MedUni Vienna,University Hospital Internal Medicine I, Clinical Dept. for Infections
city: Prague
country: Czechia
facility: FORBELI s.r.o.
city: Praha 6
country: Czechia
facility: Neurologická ambulance
city: Pforzheim
country: Germany
facility: Praxis Dr.med. Reinhardt
city: Budapest
country: Hungary
facility: Istenhegyi Géndiagnosztika Magánorvosi Rendelő Ltd.
city: Gdańsk
country: Poland
facility: St. Luke's Clinic
city: Warsaw
country: Poland
facility: Centrum Dr. Ozimek
city: Bratislava
country: Slovakia
facility: Borélia centrum Bratislava, BCB Clinic
Study officials:
affiliation: Lyme Diagnostics Ltd.
name: Bela P. Bozsik, MD
role: STUDY_DIRECTOR
References: