borreliosis Lyme Disease
Conditions
Interventions
Biomarkers
Borrelia
Lyme Disease
Sponsors
Innatoss Laboratories BV
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: - 18 years or older - a tick-bite in the previous 10 days and attachment of the tick for > 16 hours, or - an erythema migrans (EM) observed in past two weeks with a documented tick-bite or evidence of tick-bite in the center of the EM - controls: subjects without tick bite after 1 Jan 2015
Exclusion criteria
Exclusion criteria:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| * Measure cytokine production induced by recombinant Borrelia antigens using a whole-blood CMI-based test * Classify participants in an infected and not-infected group based on erythema migrans and/or seroconversion after 12 weeks * Determine the percentage of infected subjects that is identified at 4 weeks by serology or the CMI-test or both. | — |
Secondary
| Measure | Time frame |
|---|---|
| * Measure increases in addtional cytokines induced by Borrelia antigens using a whole-blood CMI-based test * Determine whether a combination of 2 or 3 biomarkers may be better in predicting the likelihood of developing disease symptoms. * Determine the variation in cytokine concentrations in unstimulated samples, antigen-stimulated samples and positive controls using the Mesoscale Discovery Technology and specifically developed ELISA tests. * Determine an appropriate cut-off that differentiates infected and non-infected subject. | — |
Countries
The Netherlands
Outcome results
None listed