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Effects of Doxycycline on Persistent Symptoms Post-neuroborreliosis

Primary Purpose

Fatigue, Radicular Pain, Cognitive Dysfunction

Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Doxycycline
Placebo
Sponsored by
Linkoeping University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Fatigue focused on measuring Persistent symptoms, Doxycycline, Placebo, Neuroborreliosis

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Clinic for Infectious Diseases, University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Doxycycline

Sugar pill

Arm Description

Treatment with Capsule Doxycycline 200 mg, once daily, for 21 days.

Capsule Placebo, 200 mg, once daily, for 21 days.

Outcomes

Primary Outcome Measures

Improvement in persistent symptoms

Secondary Outcome Measures

Changes in cytokine levels in plasma/serum in patients during treatment with DOX/PBO

Full Information

First Posted
September 17, 2010
Last Updated
September 17, 2010
Sponsor
Linkoeping University
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1. Study Identification

Unique Protocol Identification Number
NCT01205464
Brief Title
Effects of Doxycycline on Persistent Symptoms Post-neuroborreliosis
Official Title
Immunomodulatory and Clinical Effects of Doxycycline on Persistent Symptoms After Treatment of Neuroborreliosis: A Double-blind, Randomised, Crossover Study
Study Type
Interventional

2. Study Status

Record Verification Date
February 2005
Overall Recruitment Status
Completed
Study Start Date
February 2005 (undefined)
Primary Completion Date
February 2008 (Actual)
Study Completion Date
February 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Linkoeping University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fatigue, Radicular Pain, Cognitive Dysfunction, Paresthesia, Paresis
Keywords
Persistent symptoms, Doxycycline, Placebo, Neuroborreliosis

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Doxycycline
Arm Type
Active Comparator
Arm Description
Treatment with Capsule Doxycycline 200 mg, once daily, for 21 days.
Arm Title
Sugar pill
Arm Type
Placebo Comparator
Arm Description
Capsule Placebo, 200 mg, once daily, for 21 days.
Intervention Type
Drug
Intervention Name(s)
Doxycycline
Other Intervention Name(s)
Doxyferm, Vibramycin, Tetracycline
Intervention Description
Doxycycline, 100 mg, 2 capsules once daily, 24 hour time interval, 21 days.
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Sugar pill
Intervention Description
Placebo, 100 mg, 2 capsules once daily, 24 hour dosage interval, 21 days.
Primary Outcome Measure Information:
Title
Improvement in persistent symptoms
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Changes in cytokine levels in plasma/serum in patients during treatment with DOX/PBO
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pia Forsberg, MD
Organizational Affiliation
Department of Infectious Diseases, Faculty of Health Sciences, Linköping university, Sweden
Official's Role
Principal Investigator
Facility Information:
Facility Name
Clinic for Infectious Diseases, University Hospital
City
Linköping
State/Province
Östergötland
ZIP/Postal Code
58185
Country
Sweden

12. IPD Sharing Statement

Citations:
PubMed Identifier
22876748
Citation
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.
Results Reference
derived

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Effects of Doxycycline on Persistent Symptoms Post-neuroborreliosis

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