A Phase 4 interventional study of Doxycycline and Clarithromycin and hydroxychloroquine in Lyme Disease and Borrelia Infection, sponsored by Radboud University Medical Center. Completed at 2 sites in Netherlands. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-09-08.
Sponsored by Radboud University Medical Center · Phase 4, Interventional, and Treatment
The purpose of the study is to establish whether prolonged antibiotic treatment of patients diagnosed with proven or presumed PLD (as endorsed by the international ILADS guidelines) leads to better patient outcome than short-term treatment as endorsed by the Dutch CBO guidelines.
91 studies on the registry are indexed under Lyme Disease; 27 are open to participants now.
This study's enrollment of 280 is above the median of 100 across 49 interventional studies indexed under Lyme Disease.
Browse Lyme Disease studies →Radboud University Medical Center is the lead sponsor of 959 studies on the registry; 134 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
Patients with presumed or proven PLD. In this study, clinical suspicion of PLD is defined as complaints of musculoskeletal pain, arthritis or arthralgia, neuralgia or sensory disturbances (such as paresthesias or dysesthesias), neuropsychological or cognitive disorders, and persistent fatigue, that are:
Exclusion Criteria:
Drug: Doxycycline
Drug: Clarithromycin and hydroxychloroquine
Drug: Placebo
After open-label i.v. ceftriaxone 2000 mg qd via a peripheral i.v. catheter: oral Doxycycline 100 mg combined with a placebo b.i.d. for 12 weeks
Also known as: Doxycycline disper, CASnr 564-25-0 (doxycycline); 17086-28-1 (doxycycline monohydraat)
After open-label i.v. ceftriaxone 2000 mg qd via a peripheral i.v. catheter: clarithromycin 500 mg combined with hydroxychloroquine 200 mg b.i.d. for 12 weeks
Also known as: Clarithromycine Mylan, RVG 32619, CASnr 81103-11-9, Hydroxychloroquine; Plaquenil, RVG 00853, CASnr 118-42-3 (hydroxychloroquine); 737-36-4 (hydroxychloroquine sulfate)
After open-label i.v. ceftriaxone 2000 mg qd via a peripheral i.v. catheter: 12 weeks' course of double placebo b.i.d.
Global score 36-item Short-form General Health Survey (SF 36)
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.
Time frame: Week 14
Subscales 36-item Short-form General Health Survey (SF 36)
After the last comprehensive outcome assessment at week 40, patients are surveyed by post-study questionnaires at week 52 (protocol version 3.8; dated July 17, 2009; final Ethics Committee approval April 29, 2010).
Time frame: weeks 0, 14, 26, 40 and 52
Actometer recording during 14 days (objective physical activity)
Time frame: weeks 0, 14 and 40
Measurements of neuropsychological impairment
Time frame: weeks 0, 14, 26 and 40
Economic evaluation: Questionaire EQ-5D, health consumption and productivity of labour
After the last comprehensive outcome assessment at week 40, patients are surveyed by post-study questionnaires at week 52 (protocol version 3.8; dated July 17, 2009; final Ethics Committee approval April 29, 2010).
Time frame: weeks 0, 14, 26, 40 and 52
Fatigue subscale of Checklist Individual Strength (CIS)
After the last comprehensive outcome assessment at week 40, patients are surveyed by post-study questionnaires at week 52 (protocol version 3.8; dated July 17, 2009; final Ethics Committee approval April 29, 2010).
Time frame: weeks 0, 14, 26, 40 and 52
This study is completed, as verified in Sep 2016. You cannot join it, but the record below documents what was studied.
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Radboud University Medical Center