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Voortgangsverslag

Samenvatting
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Dit is een onderzoek van het RIVM, AMC en Radboudumc. Tweeduizend patiënten met Lymeziekte worden onderzocht om te kijken wie van hen na behandeling langdurige klachten ontwikkelen zoals vermoeidheid, pijn en concentratiestoornissen. Tijdens het onderzoek worden patiëntkenmerken gemeten die mogelijk bepalen of zulke klachten ontstaan, zoals een voortdurende besmetting met de “Lyme bacterie”, de aanwezigheid van andere ziekteverwekkers, of een afwijkende afweerreactie. Patiënten worden sinds 2015 geworven via het AMC, Radboudumc, het Gelre ziekenhuis Apeldoorn, via huisartsen en via de website Tekenradar.nl. Tijdens het onderzoek wordt bloed afgenomen en vullen patiënten gedurende een jaar enkele vragenlijsten in. Na dit onderzoek kan bij start van de behandeling voor Lymeziekte beter voorspeld worden of en waarom klachten zullen voortduren. Dit zal in de toekomst leiden tot behandelstrategieën die langdurige klachten voorkomen of genezen.

Resultaten
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De werving voor de studie is gestart in april 2015 tijdens de week van de teek. Deelnemers worden geworven via www.tekenradar.nl en via behandelend artsen. Tijdens en na het eerste jaar is de werving voor de studie aangepast om meer deelnemers te kunnen laten meedoen. Op dit moment doen ruim 500 deelnemers mee. Na het eerste jaar zijn de 150 foto’s van deelnemers met een erythema migrans gebruikt om tijdens de week van de teek 2016 het publiek en professionals te informeren over het herkennen van deze vroege vorm van de ziekte van Lyme. Het bleek namelijk dat deze huiduitslag door de ziekte van Lyme lang niet altijd een karakteristieke ‘rode ring’ is, maar bij 1 op de 3 mensen een egaal gekleurde vlek. Deze egale huiduitslag is moeilijker te herkennen en te onderscheiden van andere aandoeningen dan de karakteristieke “ring”. Kenmerkend voor zowel de ring als de vlek is dat deze steeds groter wordt. Snel herkennen en behandelen is belangrijk, om ernstiger klachten door de ziekte van Lyme te voorkomen.

Samenvatting van de aanvraag

Samenvatting
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In the past 15 years a three-fold increase in the number of tick bites and cases of Lyme borreliosis has been observed in the Netherlands, with currently more than one million tick bites and 20.000-30.000 Lyme borreliosis cases per year. After antibiotic treatment, around 5-20% of patients report persisting symptoms such as musculoskeletal pain, neurocognitive symptoms and fatigue. These persisting and often disabling symptoms have great impact on the quality of life. This has led to great societal concern and dissatisfaction among patients about the care provided. A civilian request (‘burgerinitiatief’) was submitted to the Dutch Parliament in order to voice these concerns and to request more research focused on improving treatment for Lyme borreliosis patients. This request was supported by an advice of the Dutch Health Council in 2013 and the Dutch Ministry of Health.

 

It is not known to what extent long-term persisting symptoms are related to the treated Borrelia infection, to persistence of Borrelia infection, auto-inflammation or immunity, co-infection with other tick-borne diseases, re-infection with Borrelia or psychological factors. Therefore, in a prospective clinical study we will: (1) prospectively investigate the clinical course of antibiotic-treated Lyme borreliosis and assess the actual risk of developing persisting symptoms; (2) assess specific determinants that predict the development of such symptoms; (3) based on those determinants, propose more personalized treatment and diagnostic strategies or interventions to prevent and resolve long-term persisting symptoms in Lyme borreliosis patients.

 

Ad (1), we will include 2000 patients with confirmed Lyme borreliosis. Symptoms and disability will be assessed with widely used and validated questionnaires at t= 0, 3, 6, 9 and 12 months after inclusion (CIS, SF-36, CFQ, PHQ-15). For these questionnaires Dutch norms exist which enable us to use cut-off scores to determine to what extent the level of symptoms patients report is clinically significant.

 

Ad (2), we will measure microbiological, immunological, genetic, clinical, cognitive-behavioral, and epidemiological parameters during follow-up that possibly predict development of persisting symptoms. For all patients, laboratory measurements will include cellular immune response against Borrelia and whole blood and PBMC restimulation assays. For a subset of patients, laboratory measurements will also include: serology for Borrelia and other tick-borne pathogens; PCRs for Borrelia on skin and blood samples; Borrelia cultures from skin samples and minimal inhibitory concentrations (MICs) for relevant antibiotics; PCRs for other tick-borne pathogens on blood and skin samples; and finally doxycycline trough levels during antibiotic treatment. In addition, in the questionnaires we measure several cognitive-behavioral variables as possible maintaining factors that (partly) predict persistence of symptoms. After follow-up, we will use prediction models to determine predictors of the occurrence and intensity of persisting symptoms. As a result, we will elucidate the role of all above described laboratory and cognitive-behavioral determinants and assess their relative predictive value in a clinical setting.

 

Ad (3), based on our findings, we will be able to propose treatment and diagnostic strategies aimed at specific determinants to resolve or prevent persisting symptoms in Lyme borreliosis patients; e.g. immunotherapy, anti-inflammatory therapy, additional antibiotic treatment against Borrelia or against specific other tick borne pathogens, or interventions aimed at changing the cognitive-behavioral determinants.

 

Patients will be included before or just after start of antibiotic treatment. In order to include 2000 patients in 3 years, we will include patients presenting at the clinical Lyme expertise centers of AMC, Radboudumc and Gelre hospital Apeldoorn, and patients presenting to their general practitioner (GP). The GP patients will be included by active recruitment through networks of collaborating GPs and through online self-reporting of patients, followed by GP confirmation. For the inclusion through online self-reporting, we will use the well-established website tekenradar.nl, which has previously been successfully used to include more than 1000 subjects per year for tick bites and Lyme borreliosis studies, including a clinical intervention trial.

 

Our study is unique and innovative by its prospective and holistic approach. The prospective follow-up up of patients allows us to identify determinants that predict the development of persisting symptoms for individual Lyme borreliosis patients. Including microbiological, genetic, immunological and cognitive-behavioral determinants in an unbiased way ensures a comprehensive approach. Through our study we will be able to identify those at risk for development of persisting symptoms and propose interventions to prevent or resolve persisting symptoms.

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