Doxycycline in Therapy of Erythema Migrans

Completed

• Conditions: Lyme Borreliosis
• Interventions: Drug: Doxycycline

• Registration Number: NCT01475708
• Lead Sponsor: University Medical Centre Ljubljana

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.

Study Timeline

• Study Start: 2011-05
• Study First Submitted: 2011-11-16
• Study First Submitted QC: 2011-11-16
• Study First Posted: 2011-11-21
• Primary Completion: 2014-10
• Study Completion: 2014-11
• Status Verified: 2016-03
• Last Update Submitted: 2016-03-23
• Last Update Posted: 2016-03-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 400

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

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

Trial Locations

Locations (1)

UMC Ljubljana, Department of Infectious Diseases; 🇸🇮 Ljubljana, Slovenia