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Doxycycline in Therapy of Erythema Migrans

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ClinicalTrials.gov Identifier: NCT01475708
Recruitment Status : Completed
First Posted : November 21, 2011
Last Update Posted : March 24, 2016
Sponsor:
Information provided by (Responsible Party):
Franc Strle, University Medical Centre Ljubljana

November 16, 2011
November 21, 2011
March 24, 2016
May 2011
October 2014   (Final data collection date for primary outcome measure)
Comparing of objective sequelae and post-treatment subjective symptoms in three groups of erythema migrans patients treated with doxycycline: with no accompanying symptoms, with mild and with severe symptoms at the beginning. [ Time Frame: 1 year follow-up ]
Same as current
Complete list of historical versions of study NCT01475708 on ClinicalTrials.gov Archive Site
Comparison of subjective symptoms between erythema migrans patients treated with doxycycline and control subjects without a history of Lyme borreliosis. [ Time Frame: 1 year follow-up ]
Same as current
Not Provided
Not Provided
 
Doxycycline in Therapy of Erythema Migrans
Doxycycline in Therapy of Erythema Migrans - do the Accompanying Symptoms Influence the Outcome?
The investigators will compare the outcome of three groups of erythema migrans patients treated with doxycycline: a group without any accompanying symptoms, with mild symptoms and with severe symptoms that require lumbar puncture.
Patients with erythema migrans treated with doxycycline for two weeks will be followed-up for one year (at 2 weeks, 2, 6 and 12 months) clinically and also by filling in the questionnaire to assess the presence of certain symptoms. Also the control group of their friends or relatives without a history of Lyme borreliosis will be included. The presence of their (unspecific) symptoms will also be recorded by the questionnaire at the time of enrollment and at 6 and 12 months.
Observational
Observational Model: Case Control
Time Perspective: Prospective
Not Provided
Retention:   Samples Without DNA
Description:
whole blood, serum, cerebrospinal fluid, skin tissue
Non-Probability Sample
Patients with erythema migrans reffered to Lyme Borreliosis outpatient clinic of the University Medical Center Ljubljana, Slovenia, Department of Infectious Diseases.
Lyme Borreliosis
Drug: Doxycycline
100 mg PO bid, 14 days
Other Name: Doxy
  • no symptoms
    patients with erythema migrans and no additional newly onset symptoms treated with doxycycline
    Intervention: Drug: Doxycycline
  • mild symptoms
    patients with erythema migrans and mild unspecific newly onset symptoms treated with doxycycline
    Intervention: Drug: Doxycycline
  • severe symptoms-lumbar puncture
    patients with erythema migrans and newly onset intense "neurologic" symptoms with lumbar puncture performed, treated with doxycycline
    Intervention: Drug: Doxycycline
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
400
Same as current
November 2014
October 2014   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • presence of erythema migrans
  • >15 years old
  • informed consent

Exclusion Criteria:

  • pregnancy
  • lactation
  • multiple erythema migrans
  • already treated with antibiotic for this episode of Lyme borreliosis
  • allergy to doxycycline
  • treatment with drugs with known interactions with doxycycline
  • cerebrospinal fluid pleocytosis
Sexes Eligible for Study: All
15 Years and older   (Child, Adult, Older Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
Slovenia
 
 
NCT01475708
EM-DOXY
No
Not Provided
Plan to Share IPD: Undecided
Franc Strle, University Medical Centre Ljubljana
University Medical Centre Ljubljana
Not Provided
Study Chair: Franc Strle, MD PhD UMC Ljubljana
University Medical Centre Ljubljana
March 2016