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- Title
Persistent Lyme Empiric Antibiotic Study Europe (PLEASE)--design of a randomized controlled trial of prolonged antibiotic treatment in patients with persistent symptoms attributed to Lyme borreliosis.
- Authors
Berende, Anneleen; Ter Hofstede, Hadewych Jm; Donders, A Rogier T; van Middendorp, Henriët; Kessels, Roy Pc; Adang, Eddy Mm; Vos, Fidel J; Evers, Andrea Wm; Kullberg, Bart Jan; ter Hofstede, Hadewych J M; Kessels, Roy P C; Adang, Eddy M M; Evers, Andrea W M
- Abstract
<bold>Background: </bold>Lyme borreliosis, a potentially severe tick-borne infection caused by Borrelia burgdorferi, can cause multi-system inflammatory disease. The incidence has been increasing, as has the number of patients with persistent symptoms attributed to Borrelia. These symptoms, also referred to as post-Lyme disease syndrome, may follow an erythema migrans or other Lyme manifestations, and include pain, fatigue, and cognitive disturbances. The optimal duration of treatment for these symptoms is a subject of controversy. The PLEASE study is designed to determine whether prolonged antibiotic treatment leads to better patient outcome than standard treatment.<bold>Methods/design: </bold>The PLEASE study is a double-blind, randomized, placebo-controlled trial. Based on power analysis and compensating for possible loss to follow-up, a minimum of 255 patients with borreliosis-attributed persistent symptoms are included. These symptoms are either (a) temporally related to an erythema migrans or otherwise proven symptomatic borreliosis, or (b) accompanied by a positive B. burgdorferi IgG or IgM immunoblot. All patients receive open-label ceftriaxone for two weeks. Patients are then randomized (ratio 1:1:1) to blinded oral follow-up treatment for 12 weeks with (I) doxycycline, (II) clarithromycin combined with hydroxychloroquine, or (III) placebo. The primary outcome is the physical component summary score (PCS) of the RAND-36 Health Status Inventory (RAND SF-36) at week 14. Secondary outcomes include physical and mental aspects of health-related quality of life (assessed by the subscales of the RAND SF-36), fatigue, neuropsychological evaluation, physical activity, and cost-effectiveness.<bold>Discussion: </bold>This article describes the background and design issues of the PLEASE study protocol. The results of this study may provide evidence for prescribing or withholding prolonged antibiotic treatment.<bold>Trial Registration: </bold>ClinicalTrials.gov: NCT01207739 , Netherlands Trial Register: NTR2469.
- Publication
BMC Infectious Diseases, 2014, Vol 14, Issue 1, p543
- ISSN
1471-2334
- Publication type
journal article
- DOI
10.1186/s12879-014-0543-y