Status:
COMPLETED
Performance Evaluation of the DualDur In Vitro Diagnostic System in the Diagnosis of Lyme Borreliosis
Lead Sponsor:
Lyme Diagnostics Ltd.
Collaborating Sponsors:
Pharmahungary Group
Conditions:
Lyme Borreliosis
Eligibility:
All Genders
18+ years
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 ...
Eligibility Criteria
Inclusion
- I. Positive trial arm
- I.1.
- 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
- 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.
Key Trial Info
Start Date :
July 2 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 4 2019
Estimated Enrollment :
400 Patients enrolled
Trial Details
Trial ID
NCT03873974
Start Date
July 2 2019
End Date
December 4 2019
Last Update
March 2 2020
Active Locations (8)
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1
MedUni Vienna,University Hospital Internal Medicine I, Clinical Dept. for Infections
Vienna, Austria, 1090
2
FORBELI s.r.o.
Prague, Czechia, 160 00
3
Neurologická ambulance
Prague, Czechia, 160 00
4
Praxis Dr.med. Reinhardt
Pforzheim, Germany, 5172