ymeProspect: a prospective study into the longterm-effects of Lyme borreliosis and determinants for persisting symptoms
- Conditions
- Borrelia infection after tick biteLyme disease10004018
- Registration Number
- NL-OMON47035
- Lead Sponsor
- RIVM
- Brief Summary
Trial is onging in other countries
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 1318
Inclusion criteria are partly dependent on the patient group and the route of inclusion.
Patients included through Tekenradar.nl:
- are 5 yrs and older.
(there are no age restrictions for patients included through clinical Lyme centers)
EM patients included through Tekenradar.nl:
- report an EM at Tekenradar.nl with a diameter larger than 5 cm and that has been present for less than 3 months;
- have a confirmed (typical or atypical) EM diagnosed by their GP;
- have not yet started treatment for the EM or started maximum 4 days earlier at the moment of inclusion;
Confirmed Lyme patients:
- have a confirmed diagnosis of early or late Lyme borreliosis;
- have not yet started treatment at the moment of inclusion, or, if included via Tekenradar.nl at most 4 days before inclusion, or, if included via Clinical Lyme Centers, at most 1 week before inclusion.
Unconfirmed Lyme patients included through the Clinical Lyme Centers:
- symptoms that are present at the time of inclusion and have persisted for more than 6 months, such as myalgia and arthralgia, neuralgia, concentration disorders and cognitive disturbances, with or without fatigue.
- have a history of an unconfirmed suspicion for Lyme disease based on a positive result of a non-recommended diagnostic test OR onset of disease symptoms (as described above) that have started within one month after a documented tick bite;
-have a negative serological test for Borrelia spp.
Exclusion criteria are partly dependent on patient group and route of inclusion.
All patients (and/or their parents/guardians):
- are unable to give informed consent or do not have a thorough command of the Dutch language.
Confirmed Lyme patients included through Tekenradar.nl:
-started treatment more than 4 days before inclusion.
Confirmed Lyme patients included through the Clinical Lyme Centers:
- started treatment more than one week before inclusion.
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method