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Effects of Doxycycline on Persistent Symptoms Post-neuroborreliosis

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ClinicalTrials.gov Identifier: NCT01205464
Recruitment Status : Completed
First Posted : September 20, 2010
Last Update Posted : September 20, 2010
Sponsor:
Information provided by:
Linkoeping University

September 17, 2010
September 20, 2010
September 20, 2010
February 2005
February 2008   (Final data collection date for primary outcome measure)
Improvement in persistent symptoms [ Time Frame: 12 weeks ]
Same as current
No Changes Posted
Changes in cytokine levels in plasma/serum in patients during treatment with DOX/PBO [ Time Frame: 12 weeks ]
Same as current
Not Provided
Not Provided
 
Effects of Doxycycline on Persistent Symptoms Post-neuroborreliosis
Immunomodulatory and Clinical Effects of Doxycycline on Persistent Symptoms After Treatment of Neuroborreliosis: A Double-blind, Randomised, Crossover Study
The aim of this randomised, double-blind crossover study was to determine whether Doxycycline has an impact on the persistent symptoms post-neuroborreliosis, through alterations in the immune response and whether such an effect could influence the clinical outcome.

Persistent symptoms after treatment of neuroborreliosis (NB) are not uncommon. There is currently no evidence for improvement of symptoms after repeated or prolonged antibiotic treatment. However, clinical observations have indicated that some patients improve during treatment with doxycycline (DOX), but regain the symptoms some time after completed treatment. This may be due to an immunomodulatory effect of the drug. The aim of this randomised, double-blind crossover study was to determine whether DOX has an impact on the persistent symptoms through alterations in the immune response and whether such an effect can influence the clinical outcome.

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.

Interventional
Not Applicable
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Basic Science
  • Fatigue
  • Radicular Pain
  • Cognitive Dysfunction
  • Paresthesia
  • Paresis
  • Drug: Doxycycline
    Doxycycline, 100 mg, 2 capsules once daily, 24 hour time interval, 21 days.
    Other Names:
    • Doxyferm
    • Vibramycin
    • Tetracycline
  • Drug: Placebo
    Placebo, 100 mg, 2 capsules once daily, 24 hour dosage interval, 21 days.
    Other Name: Sugar pill
  • Active Comparator: Doxycycline
    Treatment with Capsule Doxycycline 200 mg, once daily, for 21 days.
    Intervention: Drug: Doxycycline
  • Placebo Comparator: Sugar pill
    Capsule Placebo, 200 mg, once daily, for 21 days.
    Intervention: Drug: Placebo
Sjöwall 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
15
Same as current
February 2008
February 2008   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • a history of adequately diagnosed and treated neuroborreliosis (presence of intrathecal borrelia-antibody production)
  • 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:

  • systemic immunosuppression (treatment with corticosteroids, cytostatics etc)
  • 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
Sexes Eligible for Study: All
18 Years to 85 Years   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
Sweden
 
 
NCT01205464
151:2004/25331
Yes
Not Provided
Not Provided
Pia Forsberg, Dep. of Infectious Diseases, Faculty of Health Scienses, Linköping University, Sweden
Linkoeping University
Not Provided
Principal Investigator: Pia Forsberg, MD Department of Infectious Diseases, Faculty of Health Sciences, Linköping university, Sweden
Linkoeping University
February 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP