Midtveisevaluering - Anne Marit Solheim
Midtveisevaluering for ph.d.-graden ved Universitetet i Bergen for kandidat Anne Marit Solheim
Hovedinnhold
PhD project
By Anne Marit Solheim
Abstract
Introduction
Current treatment guidelines for European Lyme neuroborreliosis (LNB) recommend cephalosporins, penicillin or doxycycline for 14 to 28 days but evidence for optimal treatment length is poor. Treatment lengths in clinical practice tend to exceed the recommendations. Most patients experience a rapid improvement of symptoms and neurological findings within days of treatment, but some report long-term complaints. The underlying mechanisms of remaining complaints are debated, and theories as ongoing chronic infection with Borrelia burgdorferi, dysregulated immune responses, genetic predisposition, co-infection with multiple tick-borne pathogens, structural changes in CNS, and personal traits have been suggested.
The main purpose of our trial is to address the hypothesis of persistent infection as cause of remaining symptoms, by comparing efficacy of treatment with two and six weeks courses of doxycycline in LNB
Methods and analysis
The trial has a multi-center, non-inferiority, penta-blinded design. One hundred and twenty patients diagnosed with LNB according to EFNS guidelines will be randomized to six or two weeks treatment with oral doxycycline. The patients will be followed for 12 months. The primary endpoint is improvement on a composite clinical score (CCS) from baseline to 6 months after inclusion. Secondary endpoints are improvements in the CCS 12 months after inclusion, fatigue scored on FSS, subjective symptoms on the PHQ-15 scale, health related quality of life scored on RAND 36- Item Short Form Health Survey, and safety as measured by side effects of the two treatment arms. Blood and CSF are collected from inclusion and through-out the follow-up and a biobank will be established. The study started including patients in November 2015 and will continue throughout December 2019.