ymeProspect: a prospective study into the longterm-effects of Lyme borreliosis and determinants for persisting symptoms - LymeProspect

RIVM0 个研究点目标入组 1,318 人开始时间: 待定最近更新: 2024年6月11日

适应症

试验速览

Trial is onging in other countries

•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.

发起方

RIVM