Lyme BorreliosisNCT03873974
Performance Evaluation of the DualDur In Vitro Diagnostic System in the Diagnosis of Lyme Borreliosis
An observational study of Lyme Borreliosis, run by Lyme Diagnostics Ltd. at 8 sites in 6 countries.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Lyme Borreliosis
- What is being tested?
- DualDur dark-field microscopic test, DualDur dark-field automatic microscopic test and Western blot IgM and IgG
- How many people
- 400 participants
- Where
- 8 sitesin 6 countries
- Study dates
- 2 Jul 2019to 4 Dec 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
- 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.
- 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
Trial locations and contacts
8 sites in 6 countries.
8 sites in 6 countries
Czechia2 sites
FORBELI s.r.o.
Prague, 160 00
Neurologická ambulance
Prague, 160 00
Poland2 sites
St. Luke's Clinic
Gdansk, 80-557
Centrum Dr. Ozimek
Warsaw, 00-001
Austria1 site
MedUni Vienna,University Hospital Internal Medicine I, Clinical Dept. for Infections
Vienna, 1090
Hungary1 site
Istenhegyi Géndiagnosztika Magánorvosi Rendelő Ltd.
Budapest, 1125
About this study
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
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.
Read the 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.
- Conditions
- Lyme Borreliosis
- Being tested
- 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
- Keywords
- Lyme Borreliosis, Lyme disease, In Vitro Diagnostics System, Dark Field Microscopy
- Medical subject headings
- Lyme Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DualDur dark-field microscopic testDiagnostic 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 testDiagnostic 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 IgGDiagnostic 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.
Bózsik Western blot IgM and IgGDiagnostic 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.
enzyme-linked immunosorbent assay (ELISA) IgM and IgGDiagnostic test
Standard ELISA test for Lyme borreliosis.
DualDur Polymerase chain reactionDiagnostic test
DualDur PCR test for Lyme borreliosis.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: Laboratory samples evaluated within 72-144 hours of sampling.
Secondary outcomes (2)
Secondary endpoint, 1 (sensitivity of the experimental DualDur in Vitro Diagnostic System)
- The sensitivity of the experimental DualDur in Vitro Diagnostic System, based on medical diagnosis (Lyme borreliosis positive) and direct/indirect diagnostic methods.
Measured: 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)
Pairwise comparison of the sensitivity of the experimental DualDur in Vitro Diagnostic System and of the direct/indirect diagnostic methods
Measured: Laboratory samples evaluated within 72-144 hours of sampling.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2019
- Study start2 Jul 2019
- Primary completion25 Nov 2019
- Study completion4 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lyme BorreliosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lyme Diagnostics Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Pharmahungary Group
- Responsible party
- Sponsor
- Investigators
- Bela P. Bozsik, MD, Study director, Lyme Diagnostics Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03873974
- Sponsor's protocol ID
- LymeDD_CIP
- Status last verified
- Jan 2020
- First submitted
- 28 Feb 2019
- Last updated
- 2 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: To be decided later.
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03873974
- Acronym / sponsor ID
- LymeDD_CIP
- Conditions
- Lyme Borreliosis
- Keywords
- Lyme Borreliosis, Lyme disease, In Vitro Diagnostics System, Dark Field Microscopy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- Lyme Diagnostics Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Pharmahungary Group
- Study start
- 2 Jul 2019 (actual)
- Primary completion
- 25 Nov 2019 (actual)
- Study completion
- 4 Dec 2019 (actual)
- First posted
- 14 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Negative trial arm | – | 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 reactionVenous 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 |
| Positive trial arm | – | 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 reactionVenous 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DualDur dark-field microscopic testMorphologically 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 | Negative trial arm, Positive trial arm |
| DualDur dark-field automatic microscopic testMorphologically 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 | Negative trial arm, Positive trial arm |
| Western blot IgM and IgGBorrelia 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 | Negative trial arm, Positive trial arm |
| Bózsik Western blot IgM and IgGBorrelia 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 | Negative trial arm, Positive trial arm |
| enzyme-linked immunosorbent assay (ELISA) IgM and IgGStandard ELISA test for Lyme borreliosis. | Diagnostic test | Negative trial arm, Positive trial arm |
| DualDur Polymerase chain reactionDualDur PCR test for Lyme borreliosis. | Diagnostic test | Negative trial arm, Positive trial arm |
Primary outcome
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
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
2 secondary outcomes
Secondary endpoint, 1 (sensitivity of the experimental DualDur in Vitro Diagnostic System)
Time frame: 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)
Time frame: Laboratory samples evaluated within 72-144 hours of sampling.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2020.
- Official website of study Sponsor, Lyme Diagnostics Ltd.Link provided by the sponsor.
- Official website of central laboratory, Synlab Hungary Ltd.Link provided by the sponsor.
- European Parliament Resolution of 15 November 2018 on Lyme disease (Borreliosis) (2018/2774(RSP)Link provided by the sponsor.
- Official website of CRO, Pharmahungary Group.Link provided by the sponsor.
- Individual participant dataSharing planned: Undecided. To be decided later.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bela P. Bozsik, MD study director
Lyme Diagnostics Ltd.
8 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lyme Borreliosis, run by Lyme Diagnostics Ltd. at 8 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Czechia, Poland, Austria, Germany, Hungary and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary endpoint, 1 (sensitivity of the experimental DualDur in Vitro Diagnostic System) (time frame: Laboratory samples evaluated within 72-144 hours of sampling.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2020.