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

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ClinicalTrials.gov Identifier: NCT03873974
Recruitment Status : Recruiting
First Posted : March 14, 2019
Last Update Posted : November 14, 2019
Sponsor:
Collaborator:
Pharmahungary Group
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Lyme Borreliosis 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: Standard Polymerase chain reaction Diagnostic Test: enzyme-linked immunosorbent assay (ELISA) IgM and IgG Diagnostic Test: DualDur Polymerase chain reaction

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.


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Study Type : Observational
Estimated Enrollment : 400 participants
Observational Model: Other
Time Perspective: Prospective
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
Actual Study Start Date : July 2, 2019
Estimated Primary Completion Date : November 2019
Estimated Study Completion Date : February 2020

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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
  • Standard Polymerase chain reaction
  • Enzyme-Linked Immunosorbent Assay (ELISA) IgM and IgG
  • DualDur Polymerase chain reaction
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.

Diagnostic Test: 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.

Diagnostic Test: 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.

Diagnostic Test: 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.

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

Diagnostic Test: enzyme-linked immunosorbent assay (ELISA) IgM and IgG
Standard ELISA test for Lyme borreliosis.

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

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
  • Standard Polymerase chain reaction
  • Enzyme-Linked Immunosorbent Assay (ELISA) IgM and IgG
  • DualDur Polymerase chain reaction
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.

Diagnostic Test: 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.

Diagnostic Test: 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.

Diagnostic Test: 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.

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

Diagnostic Test: enzyme-linked immunosorbent assay (ELISA) IgM and IgG
Standard ELISA test for Lyme borreliosis.

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




Primary Outcome Measures :
  1. Primary endpoint, 1 (sensitivity of the experimental DualDur in Vitro Diagnostic System) [ Time Frame: 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

  2. Primary endpoint, 2 (specificity of the experimental DualDur In Vitro Diagnostic System) [ Time Frame: 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 :
  1. Secondary endpoint, 1 (sensitivity of the experimental DualDur in Vitro Diagnostic System) [ Time Frame: 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.

  2. Secondary endpoint, 2 (Pairwise comparison of the sensitivity of the experimental DualDur in Vitro Diagnostic System and of the direct/indirect diagnostic methods) [ Time Frame: 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


Other Outcome Measures:
  1. Tertiary endpoint (Validation of the image evaluation) [ Time Frame: Software evaluation done at planned study completion date, February 2020. ]
    Validation of the image evaluation software applied in the diagnosis of Lyme borreliosis by dark field microscopy.


Biospecimen Retention:   None Retained
Blood samples will be collected from patients and healthy volunteers.


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03873974


Contacts
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Contact: Andras Pal BOZSIK +36209388408 apbozsik@lymediagnostics.com
Contact: Project Manager, Lyme Diagnostics Ltd. +3630-522-7858 imre.biczo@lymediagnostics.com

Locations
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Austria
MedUni Vienna,University Hospital Internal Medicine I, Clinical Dept. for Infections Recruiting
Wien, Austria, 1090
Contact: Selma Tobudic, MD       selma.tobudic@meduniwien.ac.at   
Principal Investigator: Stefan Winkler, MD, PhD         
Czechia
FORBELI s.r.o. Recruiting
Prague, Czechia, 160 00
Contact: Michal Bajaček, MD, PhD    +420-608-164-394    mbajacek@yahoo.co.uk   
Principal Investigator: Michal Bajaček, MD, PhD         
Neurologická ambulance Recruiting
Praha 6, Czechia, 160 00
Contact: Tomáš Bouzek, MD, PhD    +420-222-943-297    tomas@bouzekordinace.cz   
Contact: Simon Bouzek    +420-777-623-007    simon.bouzek@seznam.cz   
Principal Investigator: Tomáš Bouzek, MD, PhD         
Germany
Praxis Dr.med. Reinhardt Recruiting
Pforzheim, Germany, 5172
Contact: Jan-Olaf Reinhardt, MD       dr.med.reinhardt@web.de   
Principal Investigator: Jan-Olaf Reinhardt         
Hungary
Istenhegyi Géndiagnosztika Magánorvosi Rendelő Ltd. Recruiting
Budapest, Hungary, 1125
Contact: Klára Esztó, MD         
Principal Investigator: Klára Esztó, MD         
Poland
St. Luke's Clinic Recruiting
Gdańsk, Poland, 80-557
Contact: Anna Bilecka       abiernacki@swietylukasz.pl   
Principal Investigator: Krzysztof Majdyło, MD         
Centrum Dr. Ozimek Recruiting
Warsaw, Poland, 00-001
Contact: Montse Gras       montse.gras@grascare.com   
Principal Investigator: Wojciech Ozimek, MD         
Slovakia
Borélia centrum Bratislava, BCB Clinic Recruiting
Bratislava, Slovakia, 821 02
Contact: Judita Ďurovská, MD, PhD    +421-2-206-206-88    durovska@borelioza.sk   
Contact       ambulancia@borelioza.sk   
Principal Investigator: Judita Ďurovská, MD, PhD         
Sponsors and Collaborators
Lyme Diagnostics Ltd.
Pharmahungary Group
Investigators
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Study Director: Bela P. Bozsik, MD Lyme Diagnostics Ltd.

Additional Information:
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Responsible Party: Lyme Diagnostics Ltd.
ClinicalTrials.gov Identifier: NCT03873974     History of Changes
Other Study ID Numbers: LymeDD_CIP
First Posted: March 14, 2019    Key Record Dates
Last Update Posted: November 14, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: To be decided later.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Lyme Diagnostics Ltd.:
Lyme Borreliosis
Lyme disease
In Vitro Diagnostics System
Dark Field Microscopy
Additional relevant MeSH terms:
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Borrelia Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Spirochaetales Infections
Immunoglobulin G
Immunoglobulin M
Immunologic Factors
Physiological Effects of Drugs