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Performance Evaluation of the DualDur In Vitro Diagnostic System in the Diagnosis of Lyme Borreliosis | Clinical Trials | Clareo Health

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

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

NCT03873974•Lyme Diagnostics Ltd.

View on ClinicalTrials.gov

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 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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•I. Positive trial arm
•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.
•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.

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.
+12 more criteria

Locations (8)

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

Vienna, Austria

FORBELI s.r.o.

Prague, Czechia

Neurologická ambulance

Prague, Czechia

Praxis Dr.med. Reinhardt

Pforzheim, Germany

Istenhegyi Géndiagnosztika Magánorvosi Rendelő Ltd.

Budapest, Hungary

St. Luke's Clinic

Gdansk, Poland

Centrum Dr. Ozimek

Warsaw, Poland

Borélia centrum Bratislava, BCB Clinic

Bratislava, Slovakia

Key Dates

Start Date

July 2, 2019

Primary Completion Date

November 25, 2019

Completion Date

December 4, 2019

Last Updated

March 2, 2020

Enrollment

400

ACTUAL participants

Conditions

Lyme Borreliosis

Interventions

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

DIAGNOSTIC_TEST

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 2, 2020Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

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