Performance Evaluation of the DualDur In Vitro Diagnostic System in the Diagnosis of Lyme Borreliosis

Lyme Borreliosis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03873974
• Other study ID #: LymeDD_CIP
• Status: Completed
• Start date: July 2, 2019
• Est. completion date: December 4, 2019

Study information

• Verified date: January 2020
• Source: Lyme Diagnostics Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 400
• Est. completion date: December 4, 2019
• Est. primary completion date: November 25, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lyme Borreliosis

Intervention

Diagnostic Test:
• 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 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 Polymerase chain reaction
DualDur PCR test for Lyme borreliosis.

Locations

Country	Name	City	State
Austria	MedUni Vienna,University Hospital Internal Medicine I, Clinical Dept. for Infections	Wien
Czechia	FORBELI s.r.o.	Prague
Czechia	Neurologická ambulance	Praha 6
Germany	Praxis Dr.med. Reinhardt	Pforzheim
Hungary	Istenhegyi Géndiagnosztika Magánorvosi Rendelo Ltd.	Budapest
Poland	St. Luke's Clinic	Gdansk
Poland	Centrum Dr. Ozimek	Warsaw
Slovakia	Borélia centrum Bratislava, BCB Clinic	Bratislava

Sponsors (2)

Lead Sponsor	Collaborator
Lyme Diagnostics Ltd.	Pharmahungary Group

Countries where clinical trial is conducted

Austria,  Czechia,  Germany,  Hungary,  Poland,  Slovakia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Tertiary endpoint (Validation of the image evaluation)	Validation of the image evaluation software applied in the diagnosis of Lyme borreliosis by dark field microscopy.	Software evaluation done at planned study completion date, February 2020.
Primary	Primary endpoint, 1 (sensitivity of the experimental DualDur in Vitro Diagnostic System)	The sensitivity of the experimental DualDur in Vitro Diagnostic System in the positive arm, based on medical diagnosis	Laboratory samples evaluated within 72-144 hours of sampling.
Primary	Primary endpoint, 2 (specificity of the experimental DualDur In Vitro Diagnostic System)	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	Laboratory samples evaluated within 72-144 hours of sampling.
Secondary	Secondary endpoint, 1 (sensitivity of the experimental DualDur in Vitro Diagnostic System)	1. The sensitivity of the experimental DualDur in Vitro Diagnostic System, based on medical diagnosis (Lyme borreliosis positive) and direct/indirect diagnostic methods.	Laboratory samples evaluated within 72-144 hours of sampling.
Secondary	Secondary endpoint, 2 (Pairwise comparison of the sensitivity of the experimental DualDur in Vitro Diagnostic System and of the direct/indirect diagnostic methods)	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.

External Links

•   European Parliament Resolution of 15 November 2018 on Lyme disease (Borreliosis) (2018/2774(RSP)
•   Official website of central laboratory, Synlab Hungary Ltd.
•   Official website of CRO, Pharmahungary Group.
•   Official website of study Sponsor, Lyme Diagnostics Ltd.