Effects of Doxycycline on Persistent Symptoms Post-neuroborreliosis
NCT ID: NCT01205464
Last Updated: 2010-09-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
15 participants
INTERVENTIONAL
2005-02-28
2008-02-29
Brief Summary
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Detailed Description
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A total of 15 patients from South-East Sweden with previously adequately diagnosed NB with diverse persistent symptoms ≥6months after antibiotic treatment were randomised in a double-blind, crossover fashion to receive either DOX 200 mg or placebo (PBO) once daily for three weeks, followed by a wash-out period of six weeks and a further three-weeks treatment with either DOX 200 mg or PBO once daily for three weeks. The primary outcome measures were improvement of the persistent symptoms and physical and mental health, evaluated using the visual analogue scale (VAS), the 36-item Short-Form General Health Survey (SF-36) and through physical examination with special emphasis on neurologic status at the follow-up visits. Secondary outcome measures were changes in drug-induced antigen-stimulated and unstimulated cytokine responses.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
BASIC_SCIENCE
TRIPLE
Study Groups
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Doxycycline
Treatment with Capsule Doxycycline 200 mg, once daily, for 21 days.
Doxycycline
Doxycycline, 100 mg, 2 capsules once daily, 24 hour time interval, 21 days.
Sugar pill
Capsule Placebo, 200 mg, once daily, for 21 days.
Placebo
Placebo, 100 mg, 2 capsules once daily, 24 hour dosage interval, 21 days.
Interventions
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Doxycycline
Doxycycline, 100 mg, 2 capsules once daily, 24 hour time interval, 21 days.
Placebo
Placebo, 100 mg, 2 capsules once daily, 24 hour dosage interval, 21 days.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* persistence of symptoms (with debut in conjunction with neuroborreliosis) of typical character, such as headache, radiculitis, cognitive dysfunction, fatigue, mood disorders, paresthesia or paresis \> 6 months post-treatment of neuroborreliosis
Exclusion Criteria
* ongoing infection at inclusion
* allergy against doxycycline
* pregnancy
* breast feeding
* psychiatric disease
* multiple sclerosis
* rheumatoid arthritis
* diabetes mellitus type 1 or II
* inflammatory systemic diseases
* liver ohc kidney dysfunction
* treatment with didanosine, quinapril, antacids
* malignancy
18 Years
85 Years
ALL
No
Sponsors
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Linkoeping University
OTHER_GOV
Responsible Party
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Dep. of Infectious Diseases, Faculty of Health Scienses, Linköping University, Sweden
Principal Investigators
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Pia Forsberg, MD
Role: PRINCIPAL_INVESTIGATOR
Department of Infectious Diseases, Faculty of Health Sciences, Linköping university, Sweden
Locations
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Clinic for Infectious Diseases, University Hospital
Linköping, Östergötland County, Sweden
Countries
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References
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Sjowall J, Ledel A, Ernerudh J, Ekerfelt C, Forsberg P. Doxycycline-mediated effects on persistent symptoms and systemic cytokine responses post-neuroborreliosis: a randomized, prospective, cross-over study. BMC Infect Dis. 2012 Aug 10;12:186. doi: 10.1186/1471-2334-12-186.
Other Identifiers
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151:2004/25331
Identifier Type: -
Identifier Source: org_study_id