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Doxycycline in Therapy of Erythema Migrans

Doxycycline in Therapy of Erythema Migrans - do the Accompanying Symptoms Influence the Outcome?

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01475708
Enrollment
400
Registered
2011-11-21
Start date
2011-05-31
Completion date
2014-11-30
Last updated
2016-03-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lyme Borreliosis

Keywords

Lyme borreliosis, Erythema migrans, Doxycycline, Subjective symptoms, Outcome

Brief summary

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.

Detailed 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.

Interventions

DRUGDoxycycline

100 mg PO bid, 14 days

Sponsors

University Medical Centre Ljubljana
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
15 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
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.1 year follow-up

Secondary

MeasureTime frame
Comparison of subjective symptoms between erythema migrans patients treated with doxycycline and control subjects without a history of Lyme borreliosis.1 year follow-up

Countries

Slovenia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026