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

NCT03873974 | Completed DMC

• 1 other identifier: LymeDD_CIP
• Study Type: observational
• Target: 400
• Locations: 6 countries
• Sites: 8

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.

Conditions

Lyme Borreliosis

Keywords

Lyme Borreliosis; Lyme disease; In Vitro Diagnostics System; Dark Field Microscopy

Outcome Measures

Primary Outcomes (2)

• 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 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 Outcomes (2)

• Secondary endpoint, 1 (sensitivity of the experimental DualDur in Vitro Diagnostic System)

  Laboratory samples evaluated within 72-144 hours of sampling.

• 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.

Other Outcomes (1)

• Tertiary endpoint (Validation of the image evaluation)

  Software evaluation done at planned study completion date, February 2020.

Study Arms (2)

Negative trial arm

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

Diagnostic Test: DualDur dark-field microscopic test; Diagnostic Test: DualDur dark-field automatic microscopic test; Diagnostic Test: Western blot IgM and IgG; Diagnostic Test: Bózsik Western blot IgM and IgG; Diagnostic Test: enzyme-linked immunosorbent assay (ELISA) IgM and IgG; Diagnostic Test: DualDur Polymerase chain reaction

Positive trial arm

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

Diagnostic Test: DualDur dark-field microscopic test; Diagnostic Test: DualDur dark-field automatic microscopic test; Diagnostic Test: Western blot IgM and IgG; Diagnostic Test: Bózsik Western blot IgM and IgG; Diagnostic Test: enzyme-linked immunosorbent assay (ELISA) IgM and IgG; Diagnostic Test: DualDur Polymerase chain reaction

Interventions

DualDur dark-field microscopic test DIAGNOSTIC_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.

Negative trial arm; Positive trial arm

DualDur dark-field automatic microscopic test DIAGNOSTIC_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.

Negative trial arm; Positive trial arm

Western blot IgM and IgG DIAGNOSTIC_TEST

Borrelia qualitative in vitro test in order to detect and reliably identify IgG and IgM antibodies against Borrelia burgdorferi from human serum or plasma.

Negative trial arm; Positive trial arm

Bózsik Western blot IgM and IgG DIAGNOSTIC_TEST

Borrelia qualitative in vitro test in order to detect and reliably identify IgG and IgM antibodies against Borrelia burgdorferi from human serum or plasma.

Negative trial arm; Positive trial arm

enzyme-linked immunosorbent assay (ELISA) IgM and IgG DIAGNOSTIC_TEST

Standard ELISA test for Lyme borreliosis.

Negative trial arm; Positive trial arm

DualDur Polymerase chain reaction DIAGNOSTIC_TEST

DualDur PCR test for Lyme borreliosis.

Negative trial arm; Positive trial arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• Lyme Diagnostics Ltd.: lead
• Pharmahungary Group: collaborator

Study Sites (8)

MedUni Vienna,University Hospital Internal Medicine I, Clinical Dept. for Infections

Vienna, 1090, Austria

Location

FORBELI s.r.o.

Prague, 160 00, Czechia

Location

Neurologická ambulance

Prague, 160 00, Czechia

Location

Praxis Dr.med. Reinhardt

Pforzheim, 5172, Germany

Location

Istenhegyi Géndiagnosztika Magánorvosi Rendelő Ltd.

Budapest, 1125, Hungary

Location

St. Luke's Clinic

Gdansk, 80-557, Poland

Location

Centrum Dr. Ozimek

Warsaw, 00-001, Poland

Location

Borélia centrum Bratislava, BCB Clinic

Bratislava, 821 02, Slovakia

Location

Related Links

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

Biospecimen

Retention: NONE RETAINED

Blood samples will be collected from patients and healthy volunteers.

MeSH Terms

Conditions

Lyme Disease

Condition Hierarchy (Ancestors)

Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Borrelia Infections; Spirochaetales Infections; Tick-Borne Diseases; Vector Borne Diseases

Study Officials

• Bela P. Bozsik, MD

  Lyme Diagnostics Ltd.

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 28, 2019
• First Posted: March 14, 2019
• Study Start: July 2, 2019
• Primary Completion: November 25, 2019
• Study Completion: December 4, 2019
• Last Updated: March 2, 2020

Record last verified: 2020-01

Locations

HU (1); CZ (2); AU (1); PL (2); SL (1); DE (1)