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.

Study Overview

• Status: Completed
• Conditions: Lyme Borreliosis
• Intervention / Treatment: Drug: Doxycycline

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 Type: Observational
• Enrollment (Actual): 400

Contacts and Locations

Study Locations

• Slovenia
  • Ljubljana, Slovenia, 1000
    • UMC Ljubljana, Department of Infectious Diseases

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with erythema migrans reffered to Lyme Borreliosis outpatient clinic of the University Medical Center Ljubljana, Slovenia, Department of Infectious Diseases.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
no symptoms; patients with erythema migrans and no additional newly onset symptoms treated with doxycycline	Drug: Doxycycline; 100 mg PO bid, 14 days; Other Names: Doxy
mild symptoms; patients with erythema migrans and mild unspecific newly onset symptoms treated with doxycycline	Drug: Doxycycline; 100 mg PO bid, 14 days; Other Names: Doxy
severe symptoms-lumbar puncture; patients with erythema migrans and newly onset intense "neurologic" symptoms with lumbar puncture performed, treated with doxycycline	Drug: Doxycycline; 100 mg PO bid, 14 days; Other Names: Doxy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time 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 Outcome Measures

Outcome Measure	Time 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

Collaborators and Investigators

• Sponsor: University Medical Centre Ljubljana
• Investigators: Study Chair: Franc Strle, MD PhD, UMC Ljubljana

Study record dates

Study Major Dates

• Study Start: May 1, 2011
• Primary Completion (Actual): October 1, 2014
• Study Completion (Actual): November 1, 2014

Study Registration Dates

• First Submitted: November 16, 2011
• First Submitted That Met QC Criteria: November 16, 2011
• First Posted (Estimate): November 21, 2011

Study Record Updates

• Last Update Posted (Estimate): March 24, 2016
• Last Update Submitted That Met QC Criteria: March 23, 2016
• Last Verified: March 1, 2016

More Information

Terms related to this study

• Keywords: Outcome; Doxycycline; Lyme borreliosis; Erythema migrans; Subjective symptoms
• Additional Relevant MeSH Terms: Skin Diseases; Infections; Stomatognathic Diseases; Mouth Diseases; Vector Borne Diseases; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Skin Diseases, Infectious; Skin Manifestations; Skin Diseases, Bacterial; Tick-Borne Diseases; Spirochaetales Infections; Tongue Diseases; Glossitis; Erythema; Lyme Disease; Borrelia Infections; Erythema Chronicum Migrans; Glossitis, Benign Migratory; Anti-Infective Agents; Anti-Bacterial Agents; Antiprotozoal Agents; Antiparasitic Agents; Antimalarials; Doxycycline
• Other Study ID Numbers: EM-DOXY

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided