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LymeProspect: longterm-effects of Lyme disease


- candidate number21683
- NTR NumberNTR4998
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR13-feb-2015
- Secondary IDsNL50227.094.14 EPI-280
- Public TitleLymeProspect: longterm-effects of Lyme disease
- Scientific TitleLymeProspect: a prospective study into the longterm-effects of Lyme borreliosis and determinants for persisting symptoms
- ACRONYMLymeProspect
- hypothesisAround 5-20% of Lyme borreliosis patients report persisting symptoms, such as musculoskeletal pain, neurocognitive symptoms and fatigue after treatment. It has been hypothesized that long-term persisting symptoms are related to microbiological factors (e.g. persistence of Borrelia infection or co-infection with other tick-borne pathogens), immunological factors (auto-inflammation or auto-immunity, e.g. due to genetic differences), clinical and/or epidemiological factors (e.g. late-start of treatment, severity of symptoms) or cognitive-behavioral factors. In the proposed study we will test all of these hypotheses, through a prospective follow-up of patients with early localized, early disseminated or late disseminated Lyme borreliosis.
- Healt Condition(s) or Problem(s) studiedBorrelia burgdorferi, Lyme, Tick-borne disease
- Inclusion criteriaInclusion criteria are partly dependent on the patient group and the route of inclusion.
All patients:
- are 18 yrs and older.
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 at the moment of inclusion;
Confirmed Lyme patients included through the Clinical Lyme Centers:
- have a confirmed diagnosis of early or late Lyme borreliosis;
- have not yet started treatment at the moment of inclusion, or, for disseminated Lyme borreliosis cases, 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 criteriaExclusion criteria are partly dependent on patient group and route of inclusion.
All patients:
- are unable to give informed consent or do not have a thorough command of the Dutch language.
EM patients included through Tekenradar.nl:
-started treatment for erythema migrans before inclusion.
Confirmed Lyme patients included through the Clinical Lyme Centers:
- started treatment for erythema migrans before inclusion, or for disseminated Lyme borreliosis more than one week before inclusion.
- mec approval receivedyes
- multicenter trialyes
- randomisedno
- groupParallel
- Type2 or more arms, non-randomized
- Studytypeobservational
- planned startdate 1-apr-2015
- planned closingdate31-dec-2018
- Target number of participants2300
- Interventionsnone
- Primary outcomeThe main study endpoint is the severity of persisting symptoms in confirmed Lyme patients at follow-up, based upon validated symptom and disability questionnaires. The main study parameters are all microbiological, immunological, genetic, clinical, cognitive-behavioral, and epidemiological parameters measured during follow-up, which are associated with, or could predict development of, such persisting symptoms.
- Secondary outcomeSecondary study parameters are all microbiological, immunological, genetic, clinical, cognitive-behavioral, and epidemiological parameters in unconfirmed Lyme patients with existing persisting symptoms, that are possibly similar to the determinants of such persisting symptoms that were identified in the confirmed Lyme patients. Other study parameters are health status (quality of life), relevant co-morbidity and medication use.
- TimepointsEM patients included through Tekenradar.nl:
T=0, 2 weeks, 6 weeks, 3 months, 6 months, 9 months, 12 months.
Confirmed Lyme patients included through the Clinical Lyme Centers:
T=0, 10 days, 6 weeks, 3 months, 6 months, 9 months, 12 months.
Unconfirmed Lyme patients included through the Clinical Lyme centers:
T=0, 3 months, 6 months, 9 months, 12 months.
- Trial web siteTekenradar.nl
- statusplanned
- CONTACT FOR PUBLIC QUERIES R.A.J. Boxtel, van
- CONTACT for SCIENTIFIC QUERIES
- Sponsor/Initiator Rijksinstituut voor Volksgezondheid en Milieu (RIVM)
- Funding
(Source(s) of Monetary or Material Support)
ZON-MW, The Netherlands Organization for Health Research and Development
- Publications
- Brief summaryThis is a prospective cohort study with a one-year follow-up, and a total duration of 4 years. We recruit two groups of patients: 1) Individuals ˇÝ18 yrs old with a confirmed diagnosis of previously untreated early localized or disseminated Lyme borreliosis, and 2) Individuals ˇÝ18 yrs old with an unconfirmed Lyme diagnosis in combination with existing persisting symptoms. Group 1 patients will be included before or just after start of treatment. Using questionnaires with norm scores from the population we will determine which patients develop persisting symptoms after treatment. At baseline and during follow up, we will take blood and skin samples, and record epidemiological, clinical and cognitive-behavioral characteristics. By explaining the outcome ˇ°persisting of symptomsˇ± in a prediction model by all possible measured explanatory determinants (e.g. an aberrant immune response, cognitive-behavioral factors, or persistence of infection), we can assess explanations and risk factors for the development of persisting symptoms for individual patients. The outcomes of group 1 will be compared with group 2 to identify similar mechanisms behind the persisting symptoms. Countries of recruitment: The Netherlands.
- Main changes (audit trail)
- RECORD13-feb-2015 - 3-apr-2015


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