Last reviewed · How we verify
NCT03873974
Performance Evaluation of the DualDur In Vitro Diagnostic System in the Diagnosis of Lyme Borreliosis
trial testing DualDur dark-field microscopic test in Lyme Borreliosis in 400 participants. Completed in 4 December 2019.
25 November 2019
Quick facts
| Lead sponsor | Lyme Diagnostics Ltd. |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 400 |
| Start date | 2 July 2019 |
| Primary completion | 25 November 2019 |
| Estimated completion | 4 December 2019 |
| Sites | 8 locations across Slovakia, Austria, Germany, Poland, Hungary, Czechia |
Drugs / interventions 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
- DualDur Polymerase chain reaction
Conditions studied
- Lyme Borreliosis — all drugs for Lyme Borreliosis →
Sponsor
Lyme Diagnostics Ltd.
Who can join
18 and older, any sex, with Lyme Borreliosis. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own 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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT03873974
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Lyme Borreliosis
Currently open trials in the same condition.
- NCT07226882 — A Study to Learn About Different Dosing Schedules of a Lyme Disease Vaccine in Healthy Adults · Phase 3 · active not recruiting
- NCT06835075 — Clinicaly Manifested Reinfections with Borrelia Burgdorferi Sensu Lato · active not recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03873974 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Lyme Diagnostics Ltd.
- Last refreshed: 2 March 2020
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03873974.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing