PLEASE5+ - Long-term outcomes and quality of life of patients with symptoms attributed to Lyme borreliosis
- Conditions
- Borrelia burgdorferiLyme diseaseLyme borreliosistick-borne diseasePost-treatment Lyme Disease Syndrome
- Registration Number
- NL-OMON21558
- Lead Sponsor
- Radboud university medical center, Nijmegen, the Netherlands
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 280
Subjects who have been randomized into the PLEASE study and not have subsequently withdrawn informed consent for the PLEASE or PLEASE5+ study are eligible.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.
Subjects who have withdrawn informed consent to PLEASE participation, have not consented to receive PLEASE5+ study information, or who do not provide written informed consent to PLEASE5+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.
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method - long-term impact of persistent symptoms attributed to Lyme borreliosis on (ability to) work and social costs;<br>- 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.