Doxycycline in Therapy of Erythema Migrans

NCT ID: NCT01475708

Last Updated: 2016-03-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

400 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-05-31

Study Completion Date

2014-11-30

Brief Summary

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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

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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.

Conditions

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Lyme Borreliosis

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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no symptoms

patients with erythema migrans and no additional newly onset symptoms treated with doxycycline

Doxycycline

Intervention Type DRUG

100 mg PO bid, 14 days

mild symptoms

patients with erythema migrans and mild unspecific newly onset symptoms treated with doxycycline

Doxycycline

Intervention Type DRUG

100 mg PO bid, 14 days

severe symptoms-lumbar puncture

patients with erythema migrans and newly onset intense "neurologic" symptoms with lumbar puncture performed, treated with doxycycline

Doxycycline

Intervention Type DRUG

100 mg PO bid, 14 days

Interventions

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Doxycycline

100 mg PO bid, 14 days

Intervention Type DRUG

Other Intervention Names

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Doxy

Eligibility Criteria

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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
Minimum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University Medical Centre Ljubljana

OTHER

Sponsor Role lead

Responsible Party

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Franc Strle

M.D., PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Franc Strle, MD PhD

Role: STUDY_CHAIR

UMC Ljubljana

Locations

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UMC Ljubljana, Department of Infectious Diseases

Ljubljana, , Slovenia

Site Status

Countries

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Slovenia

Other Identifiers

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EM-DOXY

Identifier Type: -

Identifier Source: org_study_id

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