Doxycycline in Therapy of Erythema Migrans

Lyme Borreliosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01475708
• Other study ID #: EM-DOXY
• Status: Completed
• Phase: N/A
• First received: November 16, 2011
• Last updated: March 23, 2016
• Start date: May 2011
• Est. completion date: November 2014

Study information

• Verified date: March 2016
• Source: University Medical Centre Ljubljana
• Contact: n/a
• Is FDA regulated: No
• Health authority: Slovenia: Ethics Committee
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 400
• Est. completion date: November 2014
• Est. primary completion date: October 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 15 Years and older

Eligibility

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

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Erythema
• Erythema Chronicum Migrans
• Lyme Borreliosis

Intervention

Drug:
• Doxycycline
100 mg PO bid, 14 days

Locations

Country	Name	City	State
Slovenia	UMC Ljubljana, Department of Infectious Diseases	Ljubljana

Sponsors (1)

Lead Sponsor	Collaborator
University Medical Centre Ljubljana

Country where clinical trial is conducted

Slovenia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	Comparison of subjective symptoms between erythema migrans patients treated with doxycycline and control subjects without a history of Lyme borreliosis.		1 year follow-up	No