Borrelia burgdorferi
Conditions
Interventions
None
Sponsors
Radboud university medical center, Nijmegen, the Netherlands
Eligibility
Inclusion criteria
Inclusion criteria: Subjects who have been randomized into the PLEASE study and not have subsequently withdrawn informed consent for the PLEASE or PLEASE5+ study are eligible. Inclusion criteria for PLEASE were: persistent symptoms that were attributed to Lyme borreliosis, either temporally related within 4 months to a physician-confirmed episode of erythema migrans or otherwise proven symptomatic Lyme borreliosis manifestation (by positive biopsy, PCR, culture, or intrathecal antibody production); or with a positive B. burgdorferi IgG or IgM immunoblot.
Exclusion criteria
Exclusion criteria: Subjects who have withdrawn informed consent to PLEASE participation, have not consented to receive PLEASE5+ study information, or who do not provide written informed consent to PLEASE5+ participation are excluded, as well as subjects who have died.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The health-related quality of life 5-8 years after participation in the randomized controlled trial on the effect of prolonged antibiotic treatment on persistent symptoms attributed to Lyme borreliosis (PLEASE). | — |
Secondary
| Measure | Time frame |
|---|---|
| - long-term impact of persistent symptoms attributed to Lyme borreliosis on (ability to) work and social costs; - reported use of medical or complementary interventions or support after PLEASE participation, and their association with the course of symptoms, quality of life and ability to work. | — |
Contacts
Public ContactHedwig Vrijmoeth
Radboudumc
Outcome results
None listed