Skip to main content

Table 1 Inclusion and exclusion criteria

From: 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

Inclusion criteria
1 Males or non-pregnant, non-lactating females who are 18 years or older
2 Complaints of musculoskeletal pain, arthritis, arthralgia, neuralgia, sensory disturbances (such as paraesthesias or dysesthesias), or neuropsychological/cognitive disorders, with or without persistent fatigue, that are:
A either temporally related to an episode of erythema migrans or otherwise proven symptomatic Lyme borreliosis (defined as within 4 months after erythema migrans as assessed by a physician, or positive biopsy, PCR, culture, or intrathecal B. burgdorferi antibodies)
B or accompanied by a positive B. burgdorferi IgG or IgM immunoblot (as defined by strict criteria in line with the European Union Concerted Action on Lyme Borreliosis (EUCALB) and the manufacturer of the immunoblot* [20],[21]), regardless of prior ELISA IgG/IgM screening results
3 Subjects must sign a written informed consent form
Exclusion criteria
1 Subjects with a known history of allergy or intolerance to tetracyclines, macrolides, hydroxychloroquine, or ceftriaxone
2 Subjects who have had more than 5 days of antimicrobial therapy with activity against B. burgdorferi within the previous 4 weeks
3 Subjects with a presumed diagnosis of neuroborreliosis (CSF pleiocytosis or intrathecal antibody production) for which intravenous antimicrobial therapy is required
4 Subjects with a known diagnosis of HIV-seropositivity or other immune disorders
5 Subjects with positive syphilis serology or signs of other spirochetal diseases
6 Subjects with moderate or severe liver disease defined as ALP, ALT, or AST greater than 3 times upper limit of normal
7 Subjects who are receiving and cannot discontinue cisapride, astemizole, terfenadine, barbiturates, phenytoin, or carbamazepine
8 Subjects who are currently enrolled on other investigational drug trials or receiving investigational agents
9 Subjects who have been previously randomized into this study
10 Severe physical or psychiatric co-morbidity that interferes with participation in the study protocol, including previous medical diagnosis of rheumatic conditions, chronic fatigue syndrome, or chronic pain conditions, as well as insufficient command of the Dutch language
11 Co-morbidity that could (partially) account for the symptoms of the subject (e.g., vitamin B12 deficiency, anemia, hypothyroidism)
12 Subjects of child-bearing potential unwilling to use contraception methods other than oral contraceptives during the study therapy period
  1. Abbreviations: PCR = polymerase chain reaction, CSF = cerebrospinal fluid, ALP = alkaline phosfatase, ALT = alanine aminotransferase, AST = aspartate aminotransferase.
  2. *EUROLINE-WB: Anti-Borrelia (whole antigen plus recombinant VlsE). EUROIMMUN Corporation, Lübeck, Germany.