A double-blind, randomised, placebo-controlled trial of prolonged antibiotic treatment after intravenous ceftriaxone in patients with (possible) persistent Lyme disease.
Completed
- Conditions
- Borrelia, Lyme
- Registration Number
- NL-OMON20560
- Lead Sponsor
- niversity Medical Center St Radboud
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 270
Inclusion Criteria
1. Males or non-pregnant, non-lactating females who are 18 years or older;
2. Women of child-bearing potential must agree to use contraception methods other than oral contraceptives during the study therapy period, since failure of oral contraceptives due to long-term antibiotic use has been described and doxycycline might be teratogenic;
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;
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Because different operationalizations of the term ‘Global score 36-item Short-form General Health Survey (SF 36)’ exist, the primary outcome measure is specified here as the ‘physical component summary score’ (PCS) of the RAND-36 Health Status Inventory (RAND SF-36, Hays 1998), which is similar to the Medical Outcomes Study (MOS) 36-item Short-Form General Health Survey (SF-36). The PCS is also known as the physical health composite score (PHC). This specification has been communicated to the local Ethics Committee on March 1, 2011, and was approved on April 6, 2011.
- Secondary Outcome Measures
Name Time Method 1. Subscales 36-item Short-form General Health Survey (SF 36). Time Frame: Weeks 0, 14, 26 and 40;<br /><br>2. Actometer recording during 14 days (objective physical activity). Time Frame: Weeks 0, 14 and 40;<br /><br>3. Measurements of neuropsychological impairment. Time Frame: Weeks 0, 14, 26 and 40;<br /><br>4. Economic evaluation: Questionaire EQ-5D, health consumption and productivity of labour. Time Frame: Weeks 0, 14, 26 and 40;<br /><br>5. Fatigue subscale of Checklist Individual Strength (CIS). Time Frame: Weeks 0, 14, 26, and 40.<br><br>After the last comprehensive outcome assessment at week 40, patients are surveyed by post-study questionnaires at week 52, regarding Subscales of 36-item Short-form General Health Survey, Economic evaluation and Fatigue subscale of Checklist Individual Strength. (Protocol version 3.8; dated July 17, 2009; final Ethics Committee approval April 29, 2010).