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Doxycycline in Therapy of Erythema Migrans

U

University Medical Centre Ljubljana

Status

Completed

Conditions

Lyme Borreliosis

Treatments

Drug: Doxycycline

Study type

Observational

Funder types

Other

Identifiers

NCT01475708
EM-DOXY

Details and patient eligibility

About

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.

Full description

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.

Enrollment

400 patients

Sex

All

Ages

15+ years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

400 participants in 3 patient groups

no symptoms
Description:
patients with erythema migrans and no additional newly onset symptoms treated with doxycycline
Treatment:
Drug: Doxycycline
mild symptoms
Description:
patients with erythema migrans and mild unspecific newly onset symptoms treated with doxycycline
Treatment:
Drug: Doxycycline
severe symptoms-lumbar puncture
Description:
patients with erythema migrans and newly onset intense "neurologic" symptoms with lumbar puncture performed, treated with doxycycline
Treatment:
Drug: Doxycycline

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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